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/ .

Feasibility, acceptability and efficacy of a text message-enhanced clinical exercise rehabilitation intervention for increasing 'whole-of-day' activity in people living with and beyond cancer.

BACKGROUND: Exercise interventions are typically delivered to people with cancer and survivors via supervised clinical rehabilitation. However, motivating and maintaining activity changes outside of the clinic setting remains challenging. This study investigated the feasibility, acceptability and efficacy of an individually-tailored, text message-enhanced intervention that focused on increasing whole-of-day activity both during and beyond a 4-week, supervised clinical exercise rehabilitation program for people with cancer and survivors. METHODS: Participants (n = 36; mean ± SD age 64.8 ± 9.6 years; 44.1 ± 30.8 months since treatment) were randomized 1:1 to receive the text message-enhanced clinical exercise rehabilitation program, or the standard clinical exercise rehabilitation program alone. Activity was assessed at baseline, 4-weeks (end of the standard program) and 12-weeks (end of enhanced program) using both device (activPAL accelerometer; sitting, standing, light-stepping, moderate-stepping) and self-report [Multimedia Activity Recall for Children and Adults (MARCA); sedentary, light, moderate-to-vigorous physical activity (MVPA)] methods. The MARCA also assessed time use domains to provide context to activity changes. Changes and intervention effects were evaluated using linear mixed models, adjusting for baseline values and potential confounders. RESULTS: The study had high retention (86%) and participants reported high levels of satisfaction [4.3/5 (±0.8)] with the intervention. Over the first 4 weeks, MARCA-assessed MVPA increased [+ 53.2 (95%CI: 2.9, 103.5) min/d] between groups, favoring the text message-enhanced program, but there were no significant intervention effects on sedentary behavior. By 12 weeks, relative to the standard group, participants in the text message-enhanced group sat less [activPAL overall sitting: - 48.2 (- 89.9, - 5.6) min/16 h awake; MARCA: -80.1 (- 156.5, - 3.8) min/d] and were participating in more physical activity [activPAL light stepping: + 7.0 (0.4, 13.6: min/16 h awake; MARCA MVPA: + 67.3 (24.0, 110.6) min/d]. The time-use domains of Quiet Time [- 63.3 (- 110.5, - 16.0) min/d] and Screen Time [- 62.0 (- 109.7, - 14.2) min/d] differed significantly between groups. CONCLUSIONS: Results demonstrate feasibility, acceptability and efficacy of a novel, text message-enhanced clinical exercise rehabilitation program to support changes in whole-of-day activity, including both physical activity and sedentary behavior. Changes were largely seen at 12-week follow-up, indicating potential for the intervention to result in continued improvement and maintenance of behavior change following a supervised exercise intervention. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12616000641493 ; date registered 17/5/16).

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.

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.

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).

Iterative development of Stand Up Australia: a multi-component intervention to reduce workplace sitting.

BACKGROUND: Sitting, particularly in prolonged, unbroken bouts, is widespread within the office workplace, yet few interventions have addressed this newly-identified health risk behaviour. This paper describes the iterative development process and resulting intervention procedures for the Stand Up Australia research program focusing on a multi-component workplace intervention to reduce sitting time. METHODS: The development of Stand Up Australia followed three phases. 1) Conceptualisation: Stand Up Australia was based on social cognitive theory and social ecological model components. These were operationalised via a taxonomy of intervention strategies and designed to target multiple levels of influence including: organisational structures (e.g. via management consultation), the physical work environment (via provision of height-adjustable workstations), and individual employees (e.g. via face-to-face coaching). 2) Formative research: Intervention components were separately tested for their feasibility and acceptability. 3) Pilot studies: Stand Up Comcare tested the integrated intervention elements in a controlled pilot study examining efficacy, feasibility and acceptability. Stand Up UQ examined the additional value of the organisational- and individual-level components over height-adjustable workstations only in a three-arm controlled trial. In both pilot studies, office workers' sitting time was measured objectively using activPAL3 devices and the intervention was refined based on qualitative feedback from managers and employees. RESULTS: Results and feedback from participants and managers involved in the intervention development phases suggest high efficacy, acceptance, and feasibility of all intervention components. The final version of the Stand Up Australia intervention includes strategies at the organisational (senior management consultation, representatives consultation workshop, team champions, staff information and brainstorming session with information booklet, and supportive emails from managers to staff), environmental (height-adjustable workstations), and individual level (face-to-face coaching session and telephone support). Stand Up Australia is currently being evaluated in the context of a cluster-randomised controlled trial at the Department of Human Services (DHS) in Melbourne, Australia. CONCLUSIONS: Stand Up Australia is an evidence-guided and systematically developed workplace intervention targeting reductions in office workers' sitting time.

Moderators of health behavior initiation and maintenance in a randomized telephone counseling trial.

OBJECTIVE: This study compares moderators of initiation and maintenance of health behavior changes. METHODS: Data come from a cluster-randomized, 12-month telephone counseling intervention for physical activity and diet, targeting type 2 diabetes or hypertension patients (n=434, Australia,2005-2007). Demographic and health-related characteristics, theoretical constructs, and baseline behavioral outcomes were considered as moderators. Mixed models, adjusting for baseline values, assessed moderation of intervention effects for trial outcomes (physical activity, intakes of fat, saturated fat, fiber, fruit, vegetables) at end-of-intervention (12 months/initiation) and maintenance follow-up (18 months), and compared moderation between these periods. RESULTS: Social support for physical activity and baseline physical activity were significant (p<0.05) moderators of physical activity at 12 months. Gender, marital status, social support for healthy eating, BMI, and number of chronic conditions were significant moderators of dietary changes at 12- and/or 18 months. Instances of moderation differing significantly between 12- and 18 months were: baseline physical activity for physical activity (initiation) and marital status for fat intake (maintenance). CONCLUSIONS: This exploratory study showed that moderation of physical activity and diet effects sometimes differed between initiation and maintenance. To identify unique moderators for initiation and/or maintenance of behavior changes, future studies need to report on and statistically test for such differences.

'Get Healthy, Stay Healthy': protocol for evaluation of a lifestyle intervention delivered by text-message following the Get Healthy Information and Coaching Service®.

BACKGROUND: Behavioural lifestyle interventions can be effective at promoting initial weight loss and supporting physical activity and dietary behaviour change, however maintaining improvements in these outcomes is often more difficult to achieve. Extending intervention contact to reinforce learnt behavioural skills has been shown to improve maintenance of behaviour change and weight loss. This trial aims to evaluate the feasibility, acceptability and efficacy of a text message-delivered extended contact intervention to enhance or maintain change in physical activity, dietary behaviour and weight loss among participants who have completed a six month Government-funded, population-based telephone coaching lifestyle program: the Get Healthy Information and Coaching Service (GHS). METHODS/DESIGN: GHS completers will be randomised to the 6-month extended contact intervention (Get Healthy, Stay Healthy, GHSH) or a no contact control group (standard practice following GHS completion). GHSH participants determine the timing and frequency of the text messages (3-13 per fortnight) and content is tailored to their behavioural and weight goals and support preferences. Two telephone tailoring calls are made (baseline, 12-weeks) to facilitate message tailoring. Primary outcomes, anthropometric (body weight and waist circumference via self-report) and behavioural (moderate-vigorous physical activity via self-report and accelerometer, fruit and vegetable intake via self-report), will be assessed at baseline (at GHS completion), 6-months (end of extended contact intervention) and 12-months (6-months post intervention contact). Secondary aims include evaluation of: the feasibility of program delivery; the acceptability for participants; theoretically-guided, potential mediators and moderators of behaviour change; dose-responsiveness; and, costs of program delivery. DISCUSSION: Findings from this trial will inform the delivery of the GHS in relation to the maintenance of behaviour change and weight loss, and will contribute to the broader science of text message lifestyle interventions delivered in population health settings. TRIAL REGISTRATION: ACTRN12613000949785.

Reducing sitting time in office workers: short-term efficacy of a multicomponent intervention.

OBJECTIVE: To investigate the short-term efficacy of a multicomponent intervention to reduce office workers' sitting time. METHODS: Allocation for this non-randomized controlled trial (n=43 participants; 56% women; 26-62 years; Melbourne, Australia) was by office floor, with data collected during July-September 2011. The 4-week intervention emphasized three key messages: "Stand Up, Sit Less, Move More" and comprised organizational, environmental, and individual elements. Changes in minutes/day at the workplace spent sitting (primary outcome), in prolonged sitting (sitting time accumulated in bouts ≥ 30 min), standing, and moving were objectively measured (activPAL3). RESULTS: Relative to the controls, the intervention group significantly reduced workplace sitting time (mean change [95%CI]: -125 [-161, -89] min/8-h workday), with changes primarily driven by a reduction in prolonged sitting time (-73 [-108, -40] min/8-h workday). Workplace sitting was almost exclusively replaced by standing (+127 [+92, +162] min/8-h workday) with non-significant changes to stepping time (-2 [-7, +4] min/8-h workday) and number of steps (-70 [-350, 210]). CONCLUSIONS: This multicomponent workplace intervention demonstrated that substantial reductions in sitting time are achievable in an office setting. Larger studies with longer timeframes are needed to assess sustainability of these changes, as well as their potential longer-term impacts on health and work-related outcomes.

Moving MobileMums forward: protocol for a larger randomized controlled trial of an improved physical activity program for women with young children.

BACKGROUND: Women with young children (under 5 years) are a key population group for physical activity intervention. Previous evidence highlights the need for individually tailored programs with flexible delivery mechanisms for this group. Our previous pilot study suggested that an intervention primarily delivered via mobile phone text messaging (MobileMums) increased self-reported physical activity in women with young children. An improved version of the MobileMums program is being compared with a minimal contact control group in a large randomised controlled trial (RCT). METHODS/DESIGN: This RCT will evaluate the efficacy, feasibility and acceptability, cost-effectiveness, mediators and moderators of the MobileMums program. Primary (moderate-vigorous physical activity) and secondary (intervention implementation data, health service use costs, intervention costs, health benefits, theoretical constructs) outcomes are assessed at baseline, 3-months (end of intervention) and 9-months (following 6-month no contact: maintenance period).The intervention commences with a face-to-face session with a behavioural counsellor to initiate rapport and gather information for tailoring the 12-week text message program. During the program participants also have access to a: MobileMums Participant Handbook, MobileMums refrigerator magnet, MobileMums Facebook© group, and a MobileMums website with a searchable, on-line exercise directory. A nominated support person also receives text messages for 12-weeks encouraging them to offer their MobileMum social support for physical activity. DISCUSSION: Results of this trial will determine the efficacy and cost-effectiveness of the MobileMums program, and the feasibility of delivering it in a community setting. It will inform the broader literature of physical activity interventions for women with young children and determine whether further investment in the translation of the program is warranted. TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611000481976).

Reducing office workers' sitting time: rationale and study design for the Stand Up Victoria cluster randomized trial.

BACKGROUND: Excessive time spent in sedentary behaviours (sitting or lying with low energy expenditure) is associated with an increased risk for type 2 diabetes, cardiovascular disease and some cancers. Desk-based office workers typically accumulate high amounts of daily sitting time, often in prolonged unbroken bouts. The Stand Up Victoria study aims to determine whether a 3-month multi-component intervention in the office setting reduces workplace sitting, particularly prolonged, unbroken sitting time, and results in improvements in cardio-metabolic biomarkers and work-related outcomes, compared to usual practice. METHODS/DESIGN: A two-arm cluster-randomized controlled trial (RCT), with worksites as the unit of randomization, will be conducted in 16 worksites located in Victoria, Australia. Work units from one organisation (Department of Human Services, Australian Government) will be allocated to either the multi-component intervention (organisational, environmental [height-adjustable workstations], and individual behavioural strategies) or to a usual practice control group. The recruitment target is 160 participants (office-based workers aged 18-65 years and working at least 0.6 full time equivalent) per arm. At each assessment (0- [baseline], 3- [post intervention], and 12-months [follow-up]), objective measurement via the activPAL3 activity monitor will be used to assess workplace: sitting time (primary outcome); prolonged sitting time (sitting time accrued in bouts of ≥30 minutes); standing time; sit-to-stand transitions; and, moving time. Additional outcomes assessed will include: non-workplace activity; cardio-metabolic biomarkers and health indicators (including fasting glucose, lipids and insulin; anthropometric measures; blood pressure; and, musculoskeletal symptoms); and, work-related outcomes (presenteeism, absenteeism, productivity, work performance). Incremental cost-effectiveness and identification of both workplace and individual-level mediators and moderators of change will also be evaluated. DISCUSSION: Stand Up Victoria will be the first cluster-RCT to evaluate the effectiveness of a multi-component intervention aimed at reducing prolonged workplace sitting in office workers. Strengths include the objective measurement of activity and assessment of the intervention on markers of cardio-metabolic health. Health- and work-related benefits, as well as the cost-effectiveness of the intervention, will help to inform future occupational practice. TRIAL REGISTRATION: ACTRN1211000742976.

Active adults recall their physical activity differently to less active adults: test-retest reliability and validity of a physical activity survey.

ISSUE ADDRESSED: This paper determined the test-retest reliability and criterion validity of a modified version of the Active Australia Survey (AAS) and whether these properties varied across participants' activity levels. METHODS: Participants (n=63) responded to repeat administrations of the AAS and wore an accelerometer for 7 days. Analyses used Spearman's rho (rs,) or weighted kappa (κ) and Bland-Altman methods. Variation in mean difference and 95% limits of agreement (LOA) across average levels of activity were tested by linear regression. RESULTS: Reliability correlations (rs; 95% confidence intervals (CI)) for minutes per week ranged from 0.40 (0.16, 0.59) to 0.80 (0.68, 0.87). For days per week, the agreement (κ; 95% CI) between administrations ranged from 0.43 (0.34, 0.73) to 0.83 (0.61, 0.93). There was a small mean difference between administrations (-8.46 moderate-vigorous minutes per week); 95% LOA widened as participants' average activity levels increased. Validity correlations (rs; 95% CI) for minutes per week ranged from 0.50 (0.28, 0.66) to 0.61 (0.43, 0.75). For days per week, the agreement (κ; 95% CI) ranged from 0.35 (0.10, 0.50) to 0.61 (0.29, 0.87). The mean difference between the AAS and accelerometer and 95% LOA both varied with participants' activity levels. CONCLUSIONS: The reliability and validity of the modified AAS were better than those of previously published versions, but varied according to participants' activity levels. So what? In this study, participants who engaged in more activity had more measurement error than less active participants. This proportionality will have important implications for cross-sectional and intervention studies. This phenomenon needs to be examined for other self-reported physical activity measures.

Evaluation of the Pragmatic Implementation of a Digital Health Intervention Promoting Healthy Nutrition, Physical Activity, and Gestational Weight Gain for Women Entering Pregnancy at a High Body Mass Index.

txt4two is a multi-modality intervention promoting healthy pregnancy nutrition, physical activity (PA), and gestational weight gain (GWG), which had been previously evaluated in a pilot randomized controlled trial (RCT). This study aimed to evaluate a pragmatic implementation of an adapted version of txt4two in a public tertiary hospital. Using a consecutive cohort design, txt4two was delivered to women with a pre-pregnancy BMI > 25 kg/m2, between 10 + 0 to 17 + 6 weeks. Control and intervention cohorts (n = 150) were planned, with surveys and weight measures at baseline and 36 weeks. The txt4two cohort received a dietetic goal-setting appointment and program (SMS, website, and videos). The navigation of disparate hospital systems and the COVID-19 pandemic saw adaptation and adoption take two years. The intervention cohort (n = 35; 43% full data) demonstrated significant differences (mean (SD)), compared to the control cohort (n = 97; 45% full data) in vegetable intake (+0.9 (1.2) versus +0.1 (0.7), p = 0.03), fiber-diet quality index (+0.6 (0.8) versus 0.1 (0.5), p = 0.012), and total diet quality index (+0.7 (1.1) versus +0.2 (±0.6), p = 0.008), but not for PA or GWG. Most (85.7%) intervention participants found txt4two extremely or moderately useful, and 92.9% would recommend it. Embedding the program in a non-RCT context raised implementation challenges. Understanding the facilitators and barriers to adaptation and adoption will strengthen the evidence for the refinement of implementation plans.

Iterative development of MobileMums: a physical activity intervention for women with young children.

BACKGROUND: To describe the iterative development process and final version of 'MobileMums': a physical activity intervention for women with young children (<5 years) delivered primarily via mobile telephone (mHealth) short messaging service (SMS). METHODS: MobileMums development followed the five steps outlined in the mHealth development and evaluation framework: 1) conceptualization (critique of literature and theory); 2) formative research (focus groups, n= 48); 3) pre-testing (qualitative pilot of intervention components, n= 12); 4) pilot testing (pilot RCT, n= 88); and, 5) qualitative evaluation of the refined intervention (n= 6). RESULTS: Key findings identified throughout the development process that shaped the MobileMums program were the need for: behaviour change techniques to be grounded in Social Cognitive Theory; tailored SMS content; two-way SMS interaction; rapport between SMS sender and recipient; an automated software platform to generate and send SMS; and, flexibility in location of a face-to-face delivered component. CONCLUSIONS: The final version of MobileMums is flexible and adaptive to individual participant's physical activity goals, expectations and environment. MobileMums is being evaluated in a community-based randomised controlled efficacy trial (ACTRN12611000481976).

The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial.

BACKGROUND: With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. METHODS: Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention), characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. RESULTS: Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also unexpected and detrimental. Physical activity screening (alone or in combination with diet) resulted in improved intervention effects for physical activity, while fruit and vegetable screening had no impact on intervention effects for these outcomes. All three types of screening impacted detrimentally on intervention effects for behaviours not being targeted by screening. CONCLUSIONS: Behavioural screening may have desirable and undesirable consequences in the context of multiple behaviour intervention trials, and thus its potential merits and pitfalls should be carefully considered.

Characteristics of control group participants who increased their physical activity in a cluster-randomized lifestyle intervention trial.

BACKGROUND: Meaningful improvement in physical activity among control group participants in lifestyle intervention trials is not an uncommon finding, and may be partly explained by participant characteristics. This study investigated which baseline demographic, health and behavioural characteristics were predictive of successful improvement in physical activity in usual care group participants recruited into a telephone-delivered physical activity and diet intervention trial, and descriptively compared these characteristics with those that were predictive of improvement among intervention group participants. METHODS: Data come from the Logan Healthy Living Program, a primary care-based, cluster-randomized controlled trial of a physical activity and diet intervention. Multivariable logistic regression models examined variables predictive of an improvement of at least 60 minutes per week of moderate-to-vigorous intensity physical activity among usual care (n = 166) and intervention group (n = 175) participants. RESULTS: Baseline variables predictive of a meaningful change in physical activity were different for the usual care and intervention groups. Being retired and completing secondary school (but no further education) were predictive of physical activity improvement for usual care group participants, whereas only baseline level of physical activity was predictive of improvement for intervention group participants. Higher body mass index and being unmarried may also be predictors of physical activity improvement for usual care participants. CONCLUSION: This is the first study to examine differences in predictors of physical activity improvement between intervention group and control group participants enrolled in a physical activity intervention trial. While further empirical research is necessary to confirm findings, results suggest that participants with certain socio-demographic characteristics may respond favourably to minimal intensity interventions akin to the treatment delivered to participants in a usual care group. In future physical activity intervention trials, it may be possible to screen participants for baseline characteristics in order to target minimal-intensity interventions to those most likely to benefit. (Australian Clinical Trials Registry, http://www.anzctr.org.au/default.aspx, ACTRN012607000195459).