Sitting less and moving more for improved metabolic and brain health in type 2 diabetes: 'OPTIMISE your health' trial protocol.

BACKGROUND: Clinical practice guidelines recommend that adults with type 2 diabetes (T2D) sit less and move more throughout the day. The 18-month OPTIMISE Your Health Clinical Trial was developed to support desk-based workers with T2D achieve these recommendations. The two-arm protocol consists of an intervention and control arms. The intervention arm receives 6 months health coaching, a sit-stand desktop workstation and an activity tracker, followed by 6 months of text message support, then 6 months maintenance. The control arm receives a delayed modified intervention after 12 months of usual care. This paper describes the methods of a randomised controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of the intervention, compared to a delayed intervention control. METHODS: This is a two-arm RCT being conducted in Melbourne, Australia. Desk-based workers (≥0.8 full-time equivalent) aged 35-65 years, ambulatory, and with T2D and managed glycaemic control (6.5-10.0% HbA1c), are randomised to the multicomponent intervention (target n = 125) or delayed-intervention control (target n = 125) conditions. All intervention participants receive 6 months of tailored health coaching assisting them to "sit less" and "move more" at work and throughout the day, supported by a sit-stand desktop workstation and an activity tracker (Fitbit). Participants receive text message-based extended care for a further 6-months (6-12 months) followed by 6-months of non-contact (12-18 months: maintenance). Delayed intervention occurs at 12-18 months for the control arm. Assessments are undertaken at baseline, 3, 6, 12, 15 and 18-months. Primary outcomes are activPAL-measured sitting time (h/16 h day), glycosylated haemoglobin (HbA1c; %, mmol/mol) and, cognitive function measures (visual learning and new memory; Paired Associates Learning Total Errors [adjusted]). Secondary, exploratory, and process outcomes will also be collected throughout the trial. DISCUSSION: The OPTIMISE Your Health trial will provide unique insights into the benefits of an intervention aimed at sitting less and moving more in desk-bound office workers with T2D, with outcomes relevant to glycaemic control, and to cardiometabolic and brain health. Findings will contribute new insights to add to the evidence base on initiating and maintaining behaviour change with clinical populations and inform practice in diabetes management. TRIAL REGISTRATION: ANZCTRN12618001159246 .

Evaluation of the Healthy Living after Cancer text message-delivered, extended contact intervention using the RE-AIM framework.

BACKGROUND: Text message-delivered interventions have potential to prevent weight regain and maintain diet and physical activity behaviours through extending contact with participants following initial weight loss, lifestyle interventions. Using the RE-AIM Framework, this study evaluated the adoption, reach, implementation, effectiveness, and maintenance of an extended contact text-message intervention following the Healthy Living after Cancer (HLaC) program. HLaC was a 6-month, telephone-delivered intervention targeting healthy diet, physical activity and weight loss for adult cancer survivors, offered by Cancer Councils (CCs) in Australia. METHODS: HLaC completers (n = 182) were offered extended contact via text messages for 6-months (HLaC+Txt). Text message content/frequency was individually tailored to participant's preferences, ascertained through two telephone-tailoring interviews with CC staff. Adoption (HLaC+Txt uptake among eligible CCs), reach (uptake by HLaC completers) and implementation (intervention cost/length; text dose) were assessed. The effectiveness of extended contact relative to historic controls was quantified by pre-to-post HLaC+Txt changes in self-reported: weight, moderate-vigorous physical activity (MVPA), fruit and vegetable intake, fat and fibre behaviour. Maintenance, following 6-months of noncontact for the intervention cohort, was assessed for these same variables. Semi-structured interviews with CC staff and participants contextualised outcomes. RESULTS: HLaC+Txt was adopted by all four CCs who had delivered HLaC. In total, 115 participants commenced HLaC+Txt, with reach ranging across CCs from 47 to 80% of eligible participants. The mean number of weeks participants received the text message intervention ranged across CCs from 18.5-22.2 weeks. Participants received (median, 25th,75th percentile) 83 (48, 119) texts, ranging across CCs from 40 to 112. The total cost of HLaC+Txt delivery was on average $AUD85.00/participant. No meaningful (p < 0.05) differences in self-reported outcomes were seen between HLaC+Txt and control cohorts. After 6-months no contact the intervention cohort had maintained weight, fruit intake, fat and fibre index scores relative to end of HLaC+Txt outcomes. Participants/CC staff perceived an important intervention component was maintaining accountability. CONCLUSIONS: While feasible to implement, HLaC+Txt was not effective in the short term. However, intervention effects during the non-contact period suggest the program supports longer term maintenance of weight and diet behaviour. Intervention delivery in this real-world context highlighted key considerations for future implementation. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12615000882527 (registered on 24/08/2015).

Dose and engagement during an extended contact physical activity and dietary behavior change intervention delivered via tailored text messaging: exploring relationships with behavioral outcomes.

BACKGROUND: Extended contact interventions delivered via text messaging are a low-cost option for promoting the long-term continuation of behavior change. This secondary analysis of a text message-delivered extended contact intervention ('Get Healthy, Stay Healthy' (GHSH)) explores the extent to which changes in physical activity, dietary behaviors and body weight were associated with the frequency of text messages (dose) and contact between the health coach and participant (engagement). METHODS: Following a telephone coaching program, participants were randomised to receive extended contact via tailored text messages (GHSH, n = 114) or no additional contact (n = 114) over a 6-month period. Message dose, timing, and content were based on participant preferences, ascertained during two tailoring telephone calls. All incoming and outgoing messages were recorded. At baseline and 6 months, participants self-reported body weight and dietary behaviors (fruit and vegetable servings/day). Moderate-vigorous physical activity (MVPA) was assessed via accelerometry. RESULTS: Median dose (25th, 75th percentile) was 53 (33, 72) text messages in total across six months. Mean fortnightly dose in weeks 1-2 was 5.5 (95 % CI: 4.3, 6.6) text messages, and remained stable (with the exception of planned decreases in weeks involving additional intervention contacts). Offset against the average fortnightly dose of goal checks (1.6, 95 % CI: 1.3, 2.0 and 1.5, 95 % CI: 1.2, 1.8, for physical activity and diet respectively), mean replies to goal checks were highest in weeks 1-2 (1.4, 95 % CI: 1.4, 1.5 and 1.3, 95 % CI: 1.2, 1.4, respectively) and tended to become lower in most weeks thereafter. Greater weight loss was positively associated with text message dose (P = 0.022), with a difference of 1.9 kg between participants receiving the most and fewest texts. There was no association between engagement and changes in outcome measures. CONCLUSIONS: A fixed dose of texts does not seem suitable to meet participants' individual preferences. Higher self-selected text doses predicted better weight outcomes. However, greater participant engagement through text replies does not predict more favourable outcomes, despite being a suggested facilitator of successful behavior change maintenance. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry number: ACTRN12613000949785. Date registered: 27 August 2013. Retrospectively registered. http://www.anzctr.org.au/ .

How does MobileMums work? Mediators of a physical activity intervention.

Objectives: To establish which Social Cognitive Theory constructs mediated effects of the MobileMums (MMP) program on increased duration and frequency of moderate-vigorous physical activity (MVPA) in women with young children (<5 years). Methods: This secondary data analysis is from a community-based randomised controlled trial. Over 12 weeks, intervention participants received a minimum of 52 individually tailored text messages, one face-to-face and one telephone-delivered session with a trained behavioural counsellor. Participants identified a support person who also received 12 weeks of individually tailored text messages. Control participants received minimal intervention contact. Data were collected pre- and post-program. Five potential mediators were assessed: barrier self-efficacy, goal setting skills, outcome expectancies, perceived environmental opportunity for physical activity and social support for physical activity. Results: Improvements in MVPA frequency were mediated by improvements in barrier self-efficacy, goal setting skills, outcome expectancies and perceived social support. Improvements in MVPA duration resulting from the MMP were mediated by improvements in women's barrier self-efficacy and goal setting skills. Conclusions: MMP improved targeted theoretical constructs and this led to changes in women's MVPA. These findings are valuable for refinement and translation of the MMP and for further research to create theory- and evidence-based physical activity behaviour change programs for women with young children.

Get Healthy, Stay Healthy: Evaluation of the Maintenance of Lifestyle Changes Six Months After an Extended Contact Intervention.

BACKGROUND: Extended intervention contact after an initial, intensive intervention is becoming accepted as best practice in behavioral weight control interventions. Whether extended contact mitigates weight regain in the longer term or it simply delays weight regain until after the extended intervention contact ceases is not clear. OBJECTIVE: This study aimed to evaluate, in multiple ways, maintenance of weight, diet, and physical activity outcomes following Get Healthy, Stay Healthy (GHSH), a text message-delivered extended contact intervention. METHODS: Clients completing the Get Healthy Service (GHS) lifestyle telephone coaching program were randomized to receive GHSH (n=114) or standard care (no additional contact, n=114) and were assessed at baseline (following completion of GHS), 6 months (following completion of GHSH), and 12 months (noncontact maintenance follow-up). At all 3 assessments, participants self-reported their body weight, waist circumference, physical activity (walking and moderate and vigorous sessions/week), and dietary behaviors (fruit and vegetable serves/day, cups of sweetened drinks per day, takeaway meals per week; fat, fiber, and total indices from the Fat and Fiber Behavior Questionnaire). Moderate-to-vigorous physical activity (MVPA) was also assessed via accelerometry. Maintenance was examined multiple ways: (1) using traditional methods to assess and compare group averages after some period of noncontact (ie, at 12 months), (2) using a novel approach to assess and compare group average changes over the first 6 months of noncontact, and (3) exploring individual participant changes (increase/decrease/no change) over the first 6 months of noncontact. RESULTS: Retention over the 12-month trial was high (92.5%, 211/228). Participants had a mean (SD) age of 53.4 (SD 12.3) years and a baseline body mass index of 29.2 (SD 5.9) kg/m2. The between-group differences detected at 6 months were still present and statistically significant at 12 months for bodyweight (-1.33 kg [-2.61 to -0.05]) and accelerometer-assessed MVPA (24.9 min/week [5.8-44.0]). None of the other outcomes were significantly favored compared with the control group at 12 months. Changes over their first 6 months of noncontact for the GHSH group were significantly better than the control group in terms of accelerometer-measured MVPA and self-reported moderate activity (other differences between the groups were all nonsignificant). In addition to the maintenance seen in the group averages, most intervention participants had maintained their behavioral outcomes during the first 6 months of noncontact. CONCLUSIONS: The GHSH participants were better off relative to where they were initially, and relative to their counterparts, not receiving extended contact in terms of MVPA. However, based on the between-group difference in bodyweight over the first 6 months of noncontact, GHSH does appear to simply delay the inevitable weight regain. However, this delay in weight regain, coupled with sustained improvements in MVPA, has public health benefits. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000949785; https://www.anzctr.org. au/Trial/Registration/TrialReview.aspx?id=364821&isReview=true.

Evaluating Short-Term Musculoskeletal Pain Changes in Desk-Based Workers Receiving a Workplace Sitting-Reduction Intervention.

This paper explores changes in musculoskeletal pain among desk-based workers over three months of a workplace-delivered, sitting-reduction intervention. Participants (n = 153, 46% female; mean ± SD aged 38.9 ± 8.0 years) were cluster-randomized (n = 18 work teams) to receive an organizational change intervention, with or without an activity tracker. A modified Nordic Musculoskeletal Questionnaire assessed pain intensity (0⁻9; none⁻worst possible) in the neck, upper and lower back, upper and lower extremities, and in total. The activPAL3 (7 days, 24 h/day protocol) measured sitting and prolonged sitting in ≥30 min bouts at work. Mixed models adjusting for cluster and intervention arm examined changes in pain (n = 104), and their associations with reductions in sitting and prolonged sitting (h/10 h at work) (n = 90). Changes in pain were nonsignificant (p ≥ 0.05) and small for total pain (-0.06 [95% CI: -0.27, 0.16]) and for each body area (-0.26 [-0.66, 0.15] for upper back to 0.09 [-0.39, 0.56] for lower back). Sitting reduction was associated with reduced lower back pain (-0.84 [-1.44, -0.25] per hour, p = 0.005); other effects were small and non-significant. No substantial average changes in pain were seen; some improvement in lower back pain might be expected with larger sitting reductions. Larger samples and diverse interventions are required for more definitive evidence.

What Do Workers Do to Reduce Their Sitting Time? The Relationships of Strategy Use and Workplace Support With Desk-Based Workers' Behavior Changes in a Workplace-Delivered Sitting-Reduction and Activity-Promoting Intervention.

OBJECTIVE: To explore workers' sitting-reduction and activity-promoting strategy use following an intervention targeting these changes, and whether strategy use and perceived workplace support impacted on 3-month sitting and activity outcomes. METHODS: This secondary analysis in desk-based workers (n = 83) utilized data collected on questionnaire-derived strategy use and workplace support, and activPAL3-derived sitting (total; prolonged, ≥30 minutes) and activity (standing; stepping) at work. RESULTS: Fourteen strategies were commonly used during the intervention. Increased usage of some strategies were significantly (P < 0.05) associated with beneficial changes in prolonged sitting or stepping only. Workplace support was significantly beneficially associated with changes in sitting, prolonged sitting, and stepping; these associations were largely independent of strategy use changes. CONCLUSIONS: Strategies were highly used, with increased use associated with some behavioral improvements. Workplace support appears essential for improving sitting and activity in the workplace.

Usage, Acceptability, and Effectiveness of an Activity Tracker in a Randomized Trial of a Workplace Sitting Intervention: Mixed-Methods Evaluation.

BACKGROUND: Wearable activity trackers are now a common feature of workplace wellness programs; however, their ability to impact sitting time (the behavior in which most of the desk-based workday is spent) is relatively unknown. This study evaluated the LUMOback, an activity tracker that targets sitting time, as part of a cluster-randomized workplace sitting intervention in desk-based office workers. OBJECTIVE: Study objectives were to explore: (1) office workers' self-directed LUMOback use, (2) individual-level characteristics associated with LUMOback use, (3) the impact of LUMOback use on activity and sitting behaviors, and (4) office workers' perceived LUMOback acceptability. METHODS: Exploratory analyses were conducted within the activity tracker intervention group (n=66) of a 2-arm cluster-randomized trial (n=153) with follow-up at 3 and 12 months. The intervention, delivered from within the workplace, consisted of organizational support strategies (eg, manager support, emails) to stand up, sit less, and move more, plus the provision of a LUMOback activity tracker. The LUMOback, worn belted around the waist, provides real-time sitting feedback through a mobile app. LUMOback usage data (n=62), Web-based questionnaires (n=33), activPAL-assessed sitting, prolonged (≥30 min bouts) and nonprolonged (<30 min bouts) sitting, standing and stepping time (7-day, 24 h/day protocol; n=40), and telephone interviews (n=27) were used to evaluate study aims. LUMOback usage data were downloaded and described. Associations between user characteristics and LUMOback usage (in the first 3 months) were analyzed using zero-inflated negative binomial models. Associations between LUMOback usage and 3-month activity outcomes were analyzed using mixed models, correcting for cluster. LUMOback acceptability was explored using 3-month questionnaire data and thematic analysis of telephone interviews (conducted 6 to 10 months post intervention commencement). RESULTS: Tracker uptake was modest (43/61, 70%), and among users, usage over the first 3 months was low (1-48 days, median 8). Usage was greatest among team leaders and those with low self-perceived scores for job control and supervisor relationships. Greater tracker use (≥5 days vs <5 days) was significantly associated only with changes in prolonged unbroken sitting (-50.7 min/16 h; 95% CI -94.0 to -7.3; P=.02) during all waking hours, and changes in nonprolonged sitting (+32.5 min/10 h; 95% CI 5.0 to 59.9; P=.02) during work hours. Participants found the LUMOback easy to use but only somewhat comfortable. Qualitatively, participants valued the real-time app feedback. Nonuptake was attributed to being busy and setup issues. Low usage was attributed to discomfort wearing the LUMOback. CONCLUSIONS: The LUMOback-although able to reduce prolonged sitting time-was only used to a limited extent, and its low usage may provide a partial explanation for the limited behavior changes that occurred. Discomfort limited the feasibility of the LUMOback for ongoing use. Such findings yield insight into how to improve upon implementing activity trackers in workplace settings.

Australian employee perceptions of an organizational-level intervention to reduce sitting.

Stand Up Lendlease-a cluster-randomized trial targeting reductions in sitting time in Australian office workers (n = 153, 18 manager-led teams, 1 organization)-effectively reduced sitting time during work hours and across the day after 12 months. The trial included two arms: organizational-support strategies (e.g. manager support, emails) with or without an activity tracker. The current study aimed to examine participant perceptions of the intervention, and perceived barriers and facilitators for reducing sitting time. Telephone interviews (n = 50 participants; conducted at 6-10 months) and three focus groups (n = 21 participants; conducted at 16 months) evaluated the intervention with qualitative data analysed thematically. Several consistent themes emerged across both short and long-term time points and intervention groups. Support and role modelling of desired behaviours from important organization personnel and receiving feedback on sitting levels were key drivers of change. Improvements in awareness about sitting, and workplace culture changes supporting active work practices were positive impacts of the intervention, but some participants also reported that initial cultural effects had dissipated and the intervention needed 'reinvigoration'. Participants desired additional 'tools' to maintain sitting less and being active, such as sit-stand desks, standing meeting tables and activity trackers. In summary, the intervention raised awareness and initiated cultural changes towards active work practices, however, additional support may be required to maintain changes in organizational culture long term. Practical tools to support sitting changes, organizational and management support and role modelling, as well as ongoing 'reinvigoration' are key strategies for short and long-term intervention success in office workplaces.

Intervening to reduce workplace sitting: mediating role of social-cognitive constructs during a cluster randomised controlled trial.

BACKGROUND: The Stand Up Victoria multi-component intervention successfully reduced workplace sitting time in both the short (three months) and long (12 months) term. To further understand how this intervention worked, we aimed to assess the impact of the intervention on four social-cognitive constructs, and examined whether these constructs mediated intervention effects on workplace sitting time at 3 and 12 months post-baseline. METHODS: Two hundred and thirty one office-based workers (14 worksites, single government employer) were randomised to intervention or control conditions by worksite. The intervention comprised organisational, environmental, and individual level elements. Participant characteristics and social-cognitive constructs (perceived behavioural control, barrier self-efficacy, perceived organisational norms and knowledge) were measured through a self-administered online survey at baseline, 3 months and 12 months. Workplace sitting time (min/8 h day) was measured with the activPAL3 device. Single multi-level mediation models were performed for each construct at both time points. RESULTS: There were significant intervention effects at 3 months on perceived behavioural control, barrier self-efficacy and perceived organisational norms. Effects on perceived organisational norms were not significant at 12 months. Perceived behavioural control significantly mediated intervention effects at 3 months, accounting for a small portion of the total effect (indirect effect: -8.6 min/8 h day, 95% CI: -18.5, -3.6 min; 7.5% of total effect). At 12 months, barrier self-efficacy significantly mediated the intervention effects on workplace sitting time (indirect effect: -10.3 min/8 h day, 95% CI: -27.3, -2.2; 13.9% of total effect). No significant effects were observed for knowledge at either time point. CONCLUSIONS: Strategies that aim to increase workers' perceived control and self-efficacy over their sitting time may be helpful components of sedentary behaviour interventions in the workplace. However, social-cognitive factors only partially explain variation in workplace sitting reduction. Understanding the importance of other levels of influence (particularly interpersonal and environmental) for initiating and maintaining workplace sedentary behaviour change will be informative for intervention development and refinement. TRIAL REGISTRATION: This study was prospectively registered with the Australian New Zealand Clinical Trials register ( ACTRN12611000742976 ) on 15 July 2011.

Women's Perceptions of Participation in an Extended Contact Text Message-Based Weight Loss Intervention: An Explorative Study.

BACKGROUND: Extending contact with participants after the end of an initial weight loss intervention has been shown to lead to maintained weight loss and related behavioral change. Mobile phone text messaging (short message service, SMS) offers a low-cost and efficacious method to deliver extended contact. In this rapidly developing area, formative work is required to understand user perspectives of text message technology. An extended contact intervention delivered by text messages following an initial telephone-delivered weight loss intervention in breast cancer survivors provided this opportunity. OBJECTIVE: The aim of this study was to qualitatively explore women's perceptions of participation in an extended contact intervention using text messaging to support long-term weight loss, physical activity, and dietary behavioral change. METHODS: Following the end of an initial 6-month randomized controlled trial of a telephone-delivered weight loss intervention (versus usual care), participants received a 6-month extended contact intervention via tailored text messages. Participant perceptions of the different types of text messages, the content, tailoring, timing, and frequency of the text messages, and the length of the intervention were assessed through semistructured interviews conducted after the extended contact intervention. The interviews were transcribed verbatim and analyzed with key themes identified. RESULTS: Participants (n=27) were a mean age of 56.0 years (SD 7.8) and mean body mass index of 30.4 kg/m2 (SD 4.2) and were at a mean of 16.1 months (SD 3.1) postdiagnosis at study baseline. Participants perceived the text messages to be useful behavioral prompts and felt the messages kept them accountable to their behavioral change goals. The individual tailoring of the text message content and schedules was a key to the acceptability of the messages; however, some women preferred the support and real-time discussion via telephone calls (during the initial intervention) compared with the text messages (during the extended contact intervention). CONCLUSIONS: Text message support was perceived as acceptable for the majority of women as a way of extending intervention contact for weight loss and behavioral maintenance. Text messages supported the maintenance of healthy behaviors established in the intervention phase and kept the women accountable to their goals. A combination of telephone calls and text message support was suggested as a more acceptable option for some of the women for an extended contact intervention.

Preventive Health Behavior Change Text Message Interventions: A Meta-analysis.

CONTEXT: Existing evidence shows that text message interventions can produce short-term health behavior change. However, understanding is limited regarding intervention characteristics moderating this effect or the long-term effectiveness of text message interventions on behavior change after contact stops. EVIDENCE ACQUISITION: MEDLINE, PubMed Central, ERIC, PsycINFO, and Web of Science were searched for articles published between April 2008 and December 2014 that evaluated an intervention targeting preventive health behaviors, delivered primarily by text message. EVIDENCE SYNTHESIS: Intervention development and design characteristics and research outcomes were evaluated for 51 studies. Thirty-five studies were included in a meta-analysis (conducted in 2015) examining overall effect size and moderators of effect size. The overall pooled effect of interventions was d=0.24 (95% CI=0.16, 0.32, p<0.001) using outcome data collected most proximal to intervention cessation. Seven studies collected data following a no-intervention maintenance period and showed a small but significant pooled maintenance effect (d=0.17, 95% CI=0.03, 0.31, p=0.017, k=7). Few variables significantly moderated intervention efficacy. Interventions that did not use a theoretic basis, used supplementary intervention components, and had a duration of 6-12 months were most effective. The specific behavior being targeted was not associated with differences in efficacy nor was tailoring, targeting, or personalization of text message content. CONCLUSIONS: Text message interventions are capable of producing positive change in preventive health behaviors. Preliminary evidence indicates that these effects can be maintained after the intervention stops. The moderator analysis findings are at odds with previous research, suggesting a need to examine moderators at the behavior-specific level.

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer.

BACKGROUND: Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. METHODS/DESIGN: Women (18-75 years; body mass index 25-45 kg/m2) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of intervention effects. DISCUSSION: This trial will provide evidence needed to inform the wide-scale provision of weight loss, physical activity and dietary interventions as part of routine survivorship care for breast cancer survivors. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry (ANZCTR) - ACTRN12612000997853 (Registered 18 September 2012).

Feasibility and acceptability of reducing workplace sitting time: a qualitative study with Australian office workers.

BACKGROUND: Office workers spend a large proportion of their working hours sitting. This may contribute to an increased risk of chronic disease and premature mortality. While there is growing interest in workplace interventions targeting prolonged sitting, few qualitative studies have explored workers' perceptions of reducing occupational sitting outside of an intervention context. This study explored barriers to reducing office workplace sitting, and the feasibility and acceptability of strategies targeting prolonged sitting in this context. METHODS: Semi-structured interviews were conducted with a convenience sample of 20 office workers (50 % women), including employees and managers, in Melbourne, Australia. The three organisations (two large, and one small organisation) were from retail, health and IT industries and had not implemented any formalised approaches to sitting reduction. Questions covered barriers to reducing sitting, the feasibility of potential strategies aimed at reducing sitting, and perceived effects on productivity. Interviews were audiotaped and transcribed verbatim. Data were analysed using thematic analysis. RESULTS: Participants reported spending most (median: 7.2 h) of their working hours sitting. The nature of computer-based work and exposure to furniture designed for a seated posture were considered to be the main factors influencing sitting time. Low cost strategies, such as standing meetings and in-person communication, were identified as feasible ways to reduce sitting time and were also perceived to have potential productivity benefits. However, social norms around appropriate workplace behaviour and workload pressures were perceived to be barriers to uptake of these strategies. The cost implications of height-adjustable workstations influenced perceptions of feasibility. Managers noted the need for an evidence-based business case supporting action on prolonged sitting, particularly in the context of limited resources and competing workplace health priorities. CONCLUSIONS: While a number of low-cost approaches to reduce workplace sitting are perceived to be feasible and acceptable in the office workplace, factors such as work demands and the organisational social context may still act as barriers to greater uptake. Building a supportive organisational culture and raising awareness of the adverse health effects of prolonged sitting may be important for improving individual-level and organisational-level motivation for change.

A Cluster Randomized Controlled Trial to Reduce Office Workers' Sitting Time: Effect on Activity Outcomes.

PURPOSE: This study aimed to evaluate the initial and long-term effectiveness of a workplace intervention compared with usual practice, targeting the reduction of sitting on activity outcomes. METHODS: Office worksites (≥1 km apart) from a single organization in Victoria, Australia, were cluster randomized to intervention (n = 7) or control (n = 7). Participants were 231 desk-based office workers (5-39 participants per worksite) working at least 0.6 full-time equivalent. The workplace-delivered intervention addressed organizational, physical environment, and individual behavioral changes to reduce sitting time. Assessments occurred at baseline, 3 months, and 12 months, with the primary outcome participants' objectively measured (activPAL3 device) workplace sitting time (minutes per 8-h workday). Secondary activity outcomes were workplace time spent standing, stepping (light, moderate to vigorous, and total), and in prolonged (≥30 min) sitting bouts (hours per 8-h workday); usual duration of workplace sitting bouts; and overall sitting, standing, and stepping time (minutes per 16-h day). Analysis was by linear mixed models, accounting for repeated-measures and clustering and adjusting for baseline values and potential confounders. RESULTS: At baseline, on average, participants (68% women; mean ± SD age = 45.6 ± 9.4 yr) sat, stood, and stepped for 78.8% ± 9.5%, 14.3% ± 8.2%, and 6.9% ± 2.9% of work hours, respectively. Workplace sitting time was significantly reduced in the intervention group compared with the controls at 3 months (-99.1 [95% confidence interval = -116.3 to -81.8] min per 8-h workday) and 12 months (-45.4 [-64.6 to -26.2] min per 8-h workday). Significant intervention effects (all favoring intervention) were observed for standing, prolonged sitting, and usual sitting bout duration at work, as well as overall sitting and standing time, with no significant or meaningful effects observed for stepping. CONCLUSIONS: This workplace-delivered multicomponent intervention was successful at reducing workplace and overall daily sitting time in both the short term and the long term.

Organizational-Level Strategies With or Without an Activity Tracker to Reduce Office Workers' Sitting Time: Rationale and Study Design of a Pilot Cluster-Randomized Trial.

BACKGROUND: The office workplace is a key setting in which to address excessive sitting time and inadequate physical activity. One major influence on workplace sitting is the organizational environment. However, the impact of organizational-level strategies on individual level activity change is unknown. Further, the emergence of sophisticated, consumer-targeted wearable activity trackers that facilitate real-time self-monitoring of activity, may be a useful adjunct to support organizational-level strategies, but to date have received little evaluation in this workplace setting. OBJECTIVE: The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of organizational-level strategies with or without an activity tracker on sitting, standing, and stepping in office workers in the short (3 months, primary aim) and long-term (12 months, secondary aim). METHODS: This study is a pilot, cluster-randomized trial (with work teams as the unit of clustering) of two interventions in office workers: organizational-level support strategies (eg, visible management support, emails) or organizational-level strategies plus the use of a waist-worn activity tracker (the LUMOback) that enables self-monitoring of sitting, standing, and stepping time and enables users to set sitting and posture alerts. The key intervention message is to 'Stand Up, Sit Less, and Move More.' Intervention elements will be implemented from within the organization by the Head of Workplace Wellbeing. Participants will be recruited via email and enrolled face-to-face. Assessments will occur at baseline, 3, and 12 months. Time spent sitting, sitting in prolonged (≥30 minute) bouts, standing, and stepping during work hours and across the day will be measured with activPAL3 activity monitors (7 days, 24 hours/day protocol), with total sitting time and sitting time during work hours the primary outcomes. Web-based questionnaires, LUMOback recorded data, telephone interviews, and focus groups will measure the feasibility and acceptability of both interventions and potential predictors of behavior change. RESULTS: Baseline and follow-up data collection has finished. Results are expected in 2016. CONCLUSIONS: This pilot, cluster-randomized trial will evaluate the feasibility, acceptability, and effectiveness of two interventions targeting reductions in sitting and increases in standing and stepping in office workers. Few studies have evaluated these intervention strategies and this study has the potential to contribute both short and long-term findings.

Evaluating the Maintenance of Lifestyle Changes in a Randomized Controlled Trial of the 'Get Healthy, Stay Healthy' Program.

BACKGROUND: Extending contact with participants after initial, intensive intervention may support maintenance of weight loss and related behaviors. OBJECTIVE: This community-wide trial evaluated a text message (short message service, SMS)-delivered, extended contact intervention ('Get Healthy, Stay Healthy' (GHSH)), which followed on from a population-level, behavioral telephone coaching program. METHODS: This study employed a parallel, randomized controlled trial: GHSH compared with no continued contact (standard practice). Participants (n=228) were recruited after completing a 6-month lifestyle telephone coaching program: mean age = 53.4 (standard deviation (SD)=12.3) years; 66.7% (152/228) female; mean body mass index (BMI) upon entering GHSH=29.5 kg/m2 (SD = 6.0). Participants received tailored text messages over a 6-month period. The message frequency, timing, and content of the messages was based on participant preference, ascertained during two tailoring telephone calls. Primary outcomes of body weight, waist circumference, physical activity (walking, moderate, and vigorous sessions/week), and dietary behaviors (fruit and vegetable serves/day, cups of sweetened drinks per day, takeaway meals per week; fat, fiber and total indices from the Fat and Fiber Behavior Questionnaire) were assessed via self-report before (baseline) and after (6-months) extended contact (with moderate-vigorous physical activity (MVPA) also assessed via accelerometry). RESULTS: Significant intervention effects, all favoring the intervention group, were observed at 6-months for change in weight (-1.35 kg, 95% confidence interval (CI): -2.24, -0.46, P=.003), weekly moderate physical activity sessions (0.56 sessions/week, 95% CI: 0.15, 0.96, P=.008) and accelerometer-assessed MVPA (24.16 minutes/week, 95% CI: 5.07, 43.25, P=.007). Waist circumference, other physical activity outcomes and dietary outcomes, did not differ significantly between groups. CONCLUSIONS: The GHSH extended care intervention led to significantly better anthropometric and physical activity outcomes than standard practice (no contact). This evidence is useful for scaling up the delivery of GHSH as standard practice following the population-level telephone coaching program.

Efficacy of a Text Message-Delivered Extended Contact Intervention on Maintenance of Weight Loss, Physical Activity, and Dietary Behavior Change.

BACKGROUND: Extending contact with participants after the end of an initial intervention is associated with successful maintenance of weight loss and behavior change. However, cost-effective methods of extending intervention contact are needed. OBJECTIVE: This study investigated whether extended contact via text message was efficacious in supporting long-term weight loss and physical activity and dietary behavior change in breast cancer survivors. METHODS: Following the end of an initial 6-month randomized controlled trial of a telephone-delivered weight loss intervention versus usual care, eligible and consenting intervention participants received a 6-month extended contact intervention via tailored text messages targeting a range of factors proposed to influence the maintenance of behavior change. In this single-group, pre-post designed study, within group changes in weight, moderate-to-vigorous physical activity (Actigraph GT3X+ accelerometers), and total energy intake (2x24 hour dietary recalls) were evaluated from baseline to end of initial intervention (6 months), end of extended contact intervention (12 months), and after a no-contact follow-up (18 months) via linear mixed models. Feasibility of implementation was assessed through systematic tracking of text message delivery process outcomes, and participant satisfaction was assessed through semistructured interviews. RESULTS: Participants at baseline (n=29) had a mean age of 54.9 years (SD 8.8), body mass index of 30.0 kg/m(2) (SD 4.2), and were recruited a mean 16.6 months (SD 3.2) post diagnosis. From baseline to 18 months, participants showed statistically significantly lower mean weight (-4.2 kg [95% CI -6.0 to -2.4]; P<.001) and higher physical activity (mean 10.4 mins/day [95% CI 3.6-17.2]; P=.003), but no significant differences in energy intake (P=.200). Participants received a mean of 8 text messages every 2 weeks (range 2-11) and reported a high rate of satisfaction. CONCLUSIONS: In comparison to interventions without extended contact, results suggest text message-delivered extended contact may support the attenuation of weight regain and promote the maintenance of physical activity.

The cost-effectiveness of the MobileMums intervention to increase physical activity among mothers with young children: a Markov model informed by a randomised controlled trial.

OBJECTIVES: To determine the cost-effectiveness of the MobileMums intervention. MobileMums is a 12-week programme which assists mothers with young children to be more physically active, primarily through the use of personalised SMS text-messages. DESIGN: A cost-effectiveness analysis using a Markov model to estimate and compare the costs and consequences of MobileMums and usual care. SETTING: This study considers the cost-effectiveness of MobileMums in Queensland, Australia. PARTICIPANTS: A hypothetical cohort of over 36 000 women with a child under 1 year old is considered. These women are expected to be eligible and willing to participate in the intervention in Queensland, Australia. DATA SOURCES: The model was informed by the effectiveness results from a 9-month two-arm community-based randomised controlled trial undertaken in 2011 and registered retrospectively with the Australian Clinical Trials Registry (ACTRN12611000481976). Baseline characteristics for the model cohort, treatment effects and resource utilisation were all informed by this trial. MAIN OUTCOME MEASURES: The incremental cost per quality-adjusted life year (QALY) of MobileMums compared with usual care. RESULTS: The intervention is estimated to lead to an increase of 131 QALYs for an additional cost to the health system of 1.1 million Australian dollars (AUD). The expected incremental cost-effectiveness ratio for MobileMums is 8608 AUD per QALY gained. MobileMums has a 98% probability of being cost-effective at a cost-effectiveness threshold of 64 000 AUD. Varying modelling assumptions has little effect on this result. CONCLUSIONS: At a cost-effectiveness threshold of 64 000 AUD, MobileMums would likely be a cost-effective use of healthcare resources in Queensland, Australia. TRIAL REGISTRATION NUMBER: Australian Clinical Trials Registry; ACTRN12611000481976.

Randomized Controlled Trial of an Improved Version of MobileMums, an Intervention for Increasing Physical Activity in Women with Young Children.

BACKGROUND: Women with young children (<5 years) are an important group for physical activity intervention. PURPOSE: The objective of the study was to evaluate the feasibility, acceptability, and efficacy of MobileMums-a physical activity intervention for women with young children. METHODS: Women were randomized to MobileMums (n = 133) or a control group (n = 130). MobileMums was delivered primarily via individually tailored text messages. Moderate to vigorous physical activity (MVPA) was measured by self-report and an accelerometer at baseline, end of the intervention (13 weeks), and 6 months later (9 months). Changes were analyzed using repeated-measures models. RESULTS: MobileMums was feasible to deliver and acceptable to women. Self-reported MVPA duration (minutes/week) and frequency (days/week) increased significantly post-intervention (13-week intervention effect 48.5 min/week, 95 % credible interval (CI) [13.4, 82.9] and 1.6 days/week, 95 % CI [0.6, 2.6]). Intervention effects were not maintained 6 months later. No effects were observed in accelerometer-derived MVPA. CONCLUSIONS: MobileMums increased women's self-reported MVPA immediately post-intervention. Future investigations need to target sustained physical activity improvements (ACTRN12611000481976).