Youth-centred participatory action approach towards co-created implementation of socially and physically activating environmental interventions in Africa and Europe: the YoPA project study protocol.

INTRODUCTION: The majority of adolescents do not meet guidelines for healthy behaviours, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway. How to develop and implement sustainable and effective interventions focused on adolescent health and well-being in urban vulnerable life situations is a key challenge. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions. METHODS AND ANALYSIS: In diverse urban environments in Denmark, the Netherlands, Nigeria and South Africa, we will engage a dynamic group of 15-20 adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (eg, policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system; tailoring; implementing and evaluating interventions during participatory meetings over the course of 3 years. YoPA applies a participatory mixed methods design guided by a novel Systems, User perspectives, Participatory co-creation process, Effects, Reach, Adoption, Implementation and Maintenance framework assessing: (i) the local systems, (ii) user perspectives, (iii) the participatory co-creation process, (iv) effects, (v) reach, (vi) adoption, (vii) implementation and (viii) maintenance of interventions. Through a realist evaluation, YoPA will explore why and how specific outcomes were reached (or not) in each setting (n=800-1000 adolescents in total). ETHICS AND DISSEMINATION: This study received approval from the ethics committees in Denmark, the Netherlands, Nigeria and South Africa and will be disseminated via various collaborative dissemination activities targeting multiple audiences. We will obtain informed consent from all participants. We envision that our YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally. TRIAL REGISTRATION NUMBER: NCT06181162.

Different sedentary behavior domains present distinct associations with eating-related indicators.

BACKGROUND: Unhealthful dietary patterns have been consistently associated with low levels of physical activity (PA), but studies dedicated to sedentary behavior (SB) are scarce, especially in adults. The few studies that investigated the association between SB and dietary patterns focused mostly on specific types of SB, such as TV-watching or screen time. SB can be accumulated in distinct domains (i.e., work, transport, and leisure-time), thus, it is key to investigate in depth the impact that different domains of SB can have on eating-related indicators. We aimed to investigate the associations between different SB domains and eating-related indicators, in a sample of adults. METHODS: Cross-sectional data from students, teachers, and staff from a Portuguese University was collected in November/2021 through an anonymous online survey. Data analyses were performed using the IBM SPSS software (version 28.0) and included descriptive statistics, partial correlations, and group comparisons using one-way ANOVA. Daily average SB at work/study, transport, and in leisure-time were self-reported and eating-related indicators were measured with several items from the Mediterranean Diet Score. Specific eating-related behaviors reflecting a protective eating pattern (e.g., eating breakfast regularly), and eating behavior traits (e.g., external eating) were also assessed. Body mass index (BMI) was calculated as weight (kg)/height(m)2. The International Physical Activity Questionnaire/Short-Form was used to assess PA. RESULTS: The sample included 301 adults (60.1% women), with a mean age of 34.5 years. Overall, leisure-time SB was inversely associated with adherence to the Mediterranean diet (r = -0.20; p < 0.001) and with a protective eating profile (r = -0.31; p < 0.001). Higher transport SB was also related to lower adherence to the Mediterranean diet (r = -0.20; p < 0.001) and to an unhealthier eating profile (r = -0.22; p < 0.001), but no associations were found for work-related SB (p > 0.05). These results persisted after the adjustment for BMI, sex, and self-reported PA. These results were impacted by the age tertile. CONCLUSIONS: Our findings suggest that adults with higher levels of SB in leisure-time and transport domains tend to report less healthy eating-related behaviors, irrespective of BMI, sex, and PA level. However, some differences in these associations were found according to the age tertile. This information may assist public health authorities in focusing their efforts in augmenting literacy on SB, namely on how SB can be accumulated via different settings. Furthermore, public health literacy efforts need to extend besides the more known deleterious effects of SB on health (e.g., diabetes, cardiovascular disease), to also include the interplay with eating indicators. Strategies to reduce SB and unhealthy eating should be particularly focused on promoting physically active forms of commuting and reducing SB in the leisure setting.

Comparing self-reported energy intake using an online dietary tool with energy expenditure by an activity tracker.

OBJECTIVE: The aim of this study was to compare self-reported total energy intake (TEI) collected using an online multiple-pass 24-h dietary recall tool (Intake24) with total energy expenditure (TEE) estimated from Fitbit Charge 2-improved algorithms in adults from the NoHoW trial (12-mo weight maintenance after free-living weight loss). METHODS: Bland-Altman plots were used to assess the level of agreement between TEI and TEE at baseline and after 12 mo. The ratio of TEI to TEE was also calculated. RESULTS: Data from 1323 participants (71% female) was included in the analysis (mean ± SD: age 45 ± 12 y, body mass index 29.7 ± 5.4 kg/m2, initial weight loss 11.5 ± 6.5 kg). The TEI was lower than TEE on average by 33%, with limits of agreement ranging from -91% to +25%. Men, younger individuals, those with higher body mass index, those with the greater weight loss before enrollment, and those who gained weight during the study underestimated to a greater extent. CONCLUSIONS: These findings contribute to the ongoing research examining the validity of technology-based dietary assessment tools.

Prioritizing a research agenda on built environments and physical activity: a twin panel Delphi consensus process with researchers and knowledge users.

BACKGROUND: The growth of urban dwelling populations globally has led to rapid increases of research and policy initiatives addressing associations between the built environment and physical activity (PA). Given this rapid proliferation, it is important to identify priority areas and research questions for moving the field forward. The objective of this study was to identify and compare research priorities on the built environment and PA among researchers and knowledge users (e.g., policy makers, practitioners). METHODS: Between September 2022 and April 2023, a three-round, modified Delphi survey was conducted among two independent panels of international researchers (n = 38) and knowledge users (n = 23) to identify similarities and differences in perceived research priorities on the built environment and PA and generate twin 'top 10' lists of the most important research needs. RESULTS: From a broad range of self-identified issues, both panels ranked in common the most pressing research priorities including stronger study designs such as natural experiments, research that examines inequalities and inequities, establishing the cost effectiveness of interventions, safety and injuries related to engagement in active transportation (AT), and considerations for climate change and climate adaptation. Additional priorities identified by researchers included: implementation science, research that incorporates Indigenous perspectives, land-use policies, built environments that support active aging, and participatory research. Additional priorities identified by knowledge users included: built environments and PA among people living with disabilities and a need for national data on trip chaining, multi-modal travel, and non-work or school-related AT. CONCLUSIONS: Five common research priorities between the two groups emerged, including (1) to better understand causality, (2) interactions with the natural environment, (3) economic evaluations, (4) social disparities, and (5) preventable AT-related injuries. The findings may help set directions for future research, interdisciplinary and intersectoral collaborations, and funding opportunities.

Are motivational and self-regulation factors associated with 12 months' weight regain prevention in the NoHoW study? An analysis of European adults.

PURPOSE: Preventing weight regain can only be achieved by sustained changes in energy balance-related behaviors that are associated with weight, such as diet and physical activity. Changes in motivation and self-regulatory skills can support long-term behavioral changes in the context of weight loss maintenance. We propose that experiencing a supportive climate care is associated with enhanced satisfaction of basic psychological needs, intrinsic goals, and autonomous motivation. These factors are expected to be associate with the utilization of self-regulation skills, leading to more sustained behavior changes and ultimately preventing weight regain. This hypothesis was tested in this ancillary analysis of the NoHoW trial, where the study arms were pooled and followed for 12 months. METHODS: The NoHoW was a three-center, large-scale weight regain prevention full factorial trial. In this longitudinal study, data were collected in adults who lost > 5% weight in the past year (N = 870, complete data only, 68.7% female, 44.10 ± 11.86 years, 84.47 ± 17.03 kg) during their participation in a 12-month digital behavior change intervention. Weight and validated measures of motivational- and self-regulatory skills-related variables were collected at baseline, six- and 12 months. Change variables were used in Mplus' path analytical models informed by NoHoW's logic model. RESULTS: The bivariate correlations confirmed key mediators' potential effect on weight outcomes in the expected causal direction. The primary analysis showed that a quarter of the variance (r2 = 23.5%) of weight regain prevention was achieved via the mechanisms of action predicted in the logic model. Specifically, our results show that supportive climate care is associated with needs satisfaction and intrinsic goal content leading to better weight regain prevention via improvements in self-regulatory skills and exercise-controlled motivation. The secondary analysis showed that more mechanisms of action are significant in participants who regained or maintained their weight. CONCLUSIONS: These results contribute to a better understanding of the mechanisms of action leading to behavior change in weight regain prevention. The most successful participants used only a few intrinsic motivation-related mechanisms of action, suggesting that habits may have been learned. While developing a digital behavior change intervention, researchers and practitioners should consider creating supportive climate care to improve needs satisfaction and intrinsic goal contents. TRIAL REGISTRATION: ISRCTN, ISRCTN88405328 , registered 12/22/2016.

Testing motivational and self-regulatory mechanisms of action on device-measured physical activity in the context of a weight loss maintenance digital intervention: A secondary analysis of the NoHoW trial.

BACKGROUND: To date, few digital behavior change interventions for weight loss maintenance focusing on long-term physical activity promotion have used a sound intervention design grounded on a logic model underpinned by behavior change theories. The current study is a secondary analysis of the weight loss maintenance NoHoW trial and investigated putative mediators of device-measured long-term physical activity levels (six to 12 months) in the context of a digital intervention. METHODS: A subsample of 766 participants (Age = 46.2 ± 11.4 years; 69.1% female; original NoHoW sample: 1627 participants) completed all questionnaires on motivational and self-regulatory variables and had all device-measured physical activity data available for zero, six and 12 months. We examined the direct and indirect effects of Virtual Care Climate on post intervention changes in moderate-to-vigorous physical activity and number of steps (six to 12 months) through changes in the theory-driven motivational and self-regulatory mechanisms of action during the intervention period (zero to six months), as conceptualized in the logic model. RESULTS: Model 1 tested the mediation processes on Steps and presented a poor fit to the data. Model 2 tested mediation processes on moderate-to-vigorous physical activity and presented poor fit to the data. Simplified models were also tested considering the autonomous motivation and the controlled motivation variables independently. These changes yielded good results and both models presented very good fit to the data for both outcome variables. Percentage of explained variance was negligible for all models. No direct or indirect effects were found from Virtual Care Climate to long term change in outcomes. Indirect effects occurred only between the sequential paths of the theory-driven mediators. CONCLUSION: This was one of the first attempts to test a serial mediation model considering psychological mechanisms of change and device-measured physical activity in a 12-month longitudinal trial. The model explained a small proportion of variance in post intervention changes in physical activity. We found different pathways of influence on theory-driven motivational and self-regulatory mechanisms but limited evidence that these constructs impacted on actual behavior change. New approaches to test these relationships are needed. Challenges and several alternatives are discussed. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN88405328. Registered December 16, 2016, https://www.isrctn.com/ISRCTN88405328.

Exploring the impact of individualized pleasure-oriented exercise sessions in a health club setting: Protocol for a randomized controlled trial.

Research on the relationship between exercise-induced affect and exercise or physical activity behavior has gained momentum in recent years, yielding several observational and longitudinal studies. However, experimental tests demonstrating a causal role of affective responses on exercise adherence are lacking. Given the need to devise exercise prescriptions that can facilitate adherence and promote regular physical activity, a Randomized Controlled Trial targeting individual pleasurable responses in a health-club setting will be conducted. The experimental protocol will compare two individualized evaluation, prescription, and supervision methods, adjusted for intensity, with the aim to explore their impact on behavioral, affective, and motivational outcomes. The planned study will be a pragmatic randomized, single-blinded, controlled superiority trial with two parallel groups and an allocation ratio of 1:1. Apparently healthy volunteer participants (N = 46) between 18 and 45 years old, who are not regularly active, will be randomly allocated to a control or experimental group. The control group will follow a general American College of Sports Medicine exercise prescription; the experimental group will follow the same prescription but with enhancements aimed at promoting pleasure: (1) individualization based on individual differences in preference for and tolerance of exercise intensity; (2) self-regulation of intensity; and (3) repeated assessments of core affect. The primary outcome will be post-intervention exercise-session attendance. Affective and motivational variables will be examined as secondary outcomes. The results are expected to advance exercise prescriptions by promoting affective regulation, thus helping to improve exercise adherence and related outcomes. TRIAL REGISTRATION: ClinicalTrials.gov; ID: NCT05416593.

Promoting physical activity through supervised vs motivational behavior change interventions in breast cancer survivors on aromatase inhibitors (PAC-WOMAN): protocol for a 3-arm pragmatic randomized controlled trial.

BACKGROUND: Aromatase inhibitors (AI) are frequently used to treat hormone-receptor-positive breast cancer, but they have multiple adverse effects (e.g., osteoporosis, arthralgia), resulting in premature therapy discontinuation/switch. Physical activity (PA) can attenuate these negative effects and improve quality of life (QoL). However, most cancer survivors fail to perform/sustain adequate PA levels, especially in the long-term. Theory-based interventions, using evidence-based behavior change techniques, aimed at promoting long-term behavior change in breast cancer survivors are effective, but remain scarce and fail to promote self-regulatory skills and better-quality motivations associated with sustained PA adoption. This paper describes the design of the PAC-WOMAN trial, which will test the long-term effectiveness and cost-effectiveness of two state of the art, group-based interventions encouraging sustained changes in PA, sedentary behavior, and QoL. Additional aims include examining the impact of both interventions on secondary outcomes (e.g., body composition, physical function), and key moderators/mediators of short and long-term changes in primary outcomes. METHODS: A 3-arm pragmatic randomized controlled trial, involving a 4-month intervention and a 12-month follow-up, will be implemented, in a real exercise setting, to compare: 1) brief PA counseling/motivational intervention; 2) structured exercise program vs. waiting-list control group. Study recruitment goal is 122 hormone-receptor-positive breast cancer survivors (stage I-III), on AI therapy (post-primary treatment completion) ≥ 1 month, ECOG 0-1. Outcome measures will be obtained at baseline, 4 months (i.e., post-intervention), 10 and 16 months. Process evaluation, analyzing implementation determinants, will also be conducted. DISCUSSION: PAC-WOMAN is expected to have a relevant impact on participants PA and QoL and provide insights for the improvement of interventions designed to promote sustained adherence to active lifestyle behaviors, facilitating its translation to community settings. TRIAL REGISTRATION: April 20, 2023 - NCT05860621. April 21, 2023 - https://doi.org/10.17605/OSF.IO/ZAQ9N April 27, 2023 - UMIN000050945.

Exploratory analysis of reflective, reactive, and homeostatic eating behaviour traits on weight change during the 18-month NoHoW weight maintenance trial.

Behaviour change interventions for weight management have found varied effect sizes and frequent weight re-gain after weight loss. There is interest in exploring whether differences in eating behaviour can be used to develop tailored weight management programs. This secondary analysis of an 18-month weight maintenance randomised controlled trial (RCT) aimed to investigate the association between individual variability in weight maintenance success and change in eating behaviour traits (EBT). Data was analysed from the NoHoW trial (Scott et al., 2019), which was designed to measure processes of change after weight loss of ≥5% body weight in the previous year. The sample included 1627 participants (mean age = 44.0 years, SD = 11.9, mean body mass index (BMI) = 29.7 kg/m2, SD = 5.4, gender = 68.7% women/31.3% men). Measurements of weight (kg) and 7 EBTs belonging to domains of reflective, reactive, or homeostatic eating were taken at 4 time points up to 18-months. Increases in measures of 'reactive eating' (binge eating, p < .001), decreases in 'reflective eating' (restraint, p < .001) and changes in 'homeostatic eating' (unlimited permission to eat, p < .001 and reliance on hunger and satiety cues, p < .05) were significantly and independently associated with concomitant weight change. Differences in EBT change were observed between participants who lost, maintained, or re-gained weight for all EBTs (p < .001) except for one subscale of intuitive eating (eating for physical reasons, p = .715). Participants who lost weight (n = 322) exhibited lower levels of reactive eating and higher levels of reflective eating than participants who re-gained weight (n = 668). EBT domains can identify individuals who need greater support to progress in weight management interventions. Increasing reflective eating and reducing reactive eating may enhance weight management success.

Providing office workers with height-adjustable workstation to reduce and interrupt workplace sitting time: protocol for the Stand Up for Healthy Aging (SUFHA) cluster randomized controlled trial.

BACKGROUND: Sedentary behavior (SB) has been linked to several negative health outcomes. Therefore, reducing SB or breaking up prolonged periods of SB improves functional fitness, food consumption, job satisfaction, and productivity. Reducing SB can be achieved by introducing a health-enhancing contextual modification promoted by a sit-stand desk in the workplace. The primary goal will be to test the effectiveness of this intervention in reducing and breaking up SB, while improving health outcomes in office-based workers during a 6-month intervention. METHODS: A two-arm (1:1), superiority parallel-group cluster RCT will be conducted to evaluate the effectiveness of this intervention in a sample of office-based workers from a university in Portugal. The intervention will consist of a psychoeducation session, motivational prompts, and contextual modification promoted by a sit-stand desk in the workplace for 6 months. The control group will work as usual in their workplace, with no contextual change or prompts during the 6-month intervention. Three assessment points will be conducted in both groups, pre-intervention (baseline), post-intervention, and a 3-month follow-up. The primary outcomes include sedentary and physical activity-related variables, which will be objectively assessed with 24 h monitoring using the ActivPAL for 7 days. The secondary outcomes include (a) biometric indices as body composition, body mass index, waist circumference, and postural inequalities; and (b) psychosocial variables such as overall and work-related fatigue, overall discomfort, life/work satisfaction, quality of life, and eating behavior. Both the primary and secondary outcomes will be assessed at each assessment point. DISCUSSION: This study will lean on the use of a sit-stand workstation for 6 months, prompted by an initial psychoeducational session and ongoing motivational prompts. We will aim to contribute to this topic by providing robust data on alternating sitting and standing postures in the workplace. TRIAL REGISTRATION: The trial was prospectively registered, and the details are at: https://doi.org/10.17605/OSF.IO/JHGPW ; Registered 15 November 2022. OSF Preregistration.

Discrepancies Between Self-reported and Objectively Measured Smartphone Screen Time: Before and During Lockdown.

Screen time shows higher health risks compared to other types of sedentary behaviors. A lockdown may simultaneously increase screen time, reduce physical activity (PA), and change time perception. Our goal was to compare self-reported against objectively measured smartphone screen time (SST) in a sample of active and inactive Portuguese adults before and during a social lockdown. This study was a cross-sectional analysis with 211 Portuguese adults (57.8% males), aged 25.2 ± 8.5 years, from two cohorts, one before the social lockdown and the other during the lockdown. SST was self-reported (SR-SST) and objectively measured using a smartphone (OM-SST). PA was self-reported. Linear regressions were performed to determine the association between SR-SST and OM-SST. A Bland and Altman analysis was used to assess agreement. Independent T-tests were performed for comparisons between cohorts and paired sample T-tests for comparisons within each cohort. The cohort assessed during the lockdown showed a higher SST than the cohort assessed before the lockdown (OM-SST; p < 0.001 and SR-SST; p = 0.009). Before the lockdown, there was no difference between SR-SST and OM-SST (p = 0.100). However, during the social lockdown, although the agreement between SR-SST and OM-SST was good (ICC = 0.72), participants systematically underestimated their SST by ~ 71 min/day (p < 0.001), and this underestimation was higher in inactive participants (~ 85 min/day) than in active individuals (~ 49 min/day). The general population needs to be aware of the benefits of limiting screen time, especially during periods of societal modifications, such as a generalized lockdown. There was a tendency to underestimate SST, meaning a lack of awareness of the actual time spent in this potentially deleterious behavior. This underestimation was more pronounced during the lockdown period and for the inactive participants, thus posing a greater health risk. The findings from this investigation entail relevant information for policy makers to delineate strategies for reducing population screen time from a preventive health perspective.

Substituting sedentary time with sleep or physical activity and subsequent weight-loss maintenance.

OBJECTIVE: In this study, the associations between the substitution of sedentary time with sleep or physical activity at different intensities and subsequent weight-loss maintenance were examined. METHODS: This prospective study included 1152 adults from the NoHoW trial who had achieved a successful weight loss of ≥5% during the 12 months prior to baseline and had BMI ≥25 kg/m2 before losing weight. Physical activity and sleep were objectively measured during a 14-day period at baseline. Change in body weight was included as the primary outcome. Secondary outcomes were changes in body fat percentage and waist circumference. Cardiometabolic variables were included as exploratory outcomes. RESULTS: Using isotemporal substitution models, no associations were found between activity substitutions and changes in body weight or waist circumference. However, the substitution of sedentary behavior with moderate-to-vigorous physical activity was associated with a decrease in body fat percentage during the first 6 months of the trial (-0.33% per 30 minutes higher moderate-to-vigorous physical activity [95% CI: -0.60% to -0.07%], p = 0.013). CONCLUSIONS: Sedentary behavior had little or no influence on subsequent weight-loss maintenance, but during the early stages of a weight-loss maintenance program, substituting sedentary behavior with moderate-to-vigorous physical activity may prevent a gain in body fat percentage.

Motivational and self-efficacy reciprocal effects during a 12-month' weight regain prevention program.

OBJECTIVE: Weight regain prevention is a critical public health challenge. Digital behaviour change interventions provide a scalable platform for applying and testing behaviour change theories in this challenging context. This study's goal was to analyse reciprocal effects between psychosocial variables (i.e., needs satisfaction, eating regulation, self-efficacy) and weight over 12 months using data from a large sample of participants engaged in a weight regain prevention trial. METHODS: The NoHoW study is a three-centre, large-scale weight regain prevention trial. Adults who lost >5% of their weight in the past year (N = 1627, 68.7% female, 44.10 ± 11.86 years, 84.47 ± 17.03 kg) participated in a 12-month' digital behaviour change-based intervention. Weight and validated measures of basic psychological needs satisfaction, eating regulation and self-efficacy were collected at baseline, six- and 12 months. Correlational, latent growth models and cross-lagged analysis were used to identify potential reciprocal effects. RESULTS: Baseline higher scores of needs satisfaction and self-efficacy were associated with six- and 12-month' weight loss. Baseline weight was linked to all psychosocial variables at six months, and six-months weight was associated with needs satisfaction and self-efficacy at 12 months. During the 12 months, increases in eating regulation, needs satisfaction and self-efficacy were associated with weight loss over the same period, and reciprocal effects were observed between the variables, suggesting the existence of Weight Management Cycles. CONCLUSIONS: While further studies are needed, during long-term weight regain prevention, weight decrease, needs satisfaction and self-efficacy may lead to Weight Management Cycles, which, if recurrent, may provide sustained prevention of weight regain.

What goes on in digital behaviour change interventions for weight loss maintenance targeting physical activity: A scoping review.

Objective: To identify the core components of digital behaviour change interventions for weight loss maintenance targeting physical activity, in terms of: (i) behaviour change techniques, (ii) mechanisms of action, (iii) modes of delivery, (iv) dose and (v) tailoring/personalization. In addition, the links between these components were investigated. Methods: A literature search was performed in five electronic databases: PubMed, Embase, CINHAL, PsycINFO and Web of Science. Two reviewers independently screened the identified articles and extracted data related with the study characteristics and behaviour change techniques, mechanism of action, mode of delivery, dose, and tailoring, using standardized classifications whenever available (e.g. behaviour change techniques taxonomy). Results: Seventeen articles reporting 11 original studies were selected. Two studies were protocols, 9 studies presented results for weight change and all but one showed no significant differences between the intervention and control groups. Eight studies (73%) provided adequate information on behaviour change techniques. Five studies (45%) provided partial information about how the behaviour change techniques were linked to mechanisms of action, and only one study (0.9%) described these links for all the techniques. Around half of the studies reported the modes through which behaviour change techniques were delivered. Descriptions of dose were present in most studies, but with minimal information. The use of tailoring or personalization approaches was mentioned in eight studies (73%), but descriptions of what was tailored and how were minimal. Conclusions: The compilation of information regarding intervention components was difficult due to the lack of information and systematization in reporting across papers. This is particularly true for the reporting of the links between behaviour change techniques and the other core intervention components. This information is crucial to help us understand in the context of behaviour change interventions what works or does not work, how it works and why.

Evaluation of the Immediate Effects of Web-Based Intervention Modules for Goals, Planning, and Coping Planning on Physical Activity: Secondary Analysis of a Randomized Controlled Trial on Weight Loss Maintenance.

BACKGROUND: The use of digital interventions can be accurately monitored via log files. However, monitoring engagement with intervention goals or enactment of the actual behaviors targeted by the intervention is more difficult and is usually evaluated based on pre-post measurements in a controlled trial. OBJECTIVE: The objective of this paper is to evaluate if engaging with 2 digital intervention modules focusing on (1) physical activity goals and action plans and (2) coping with barriers has immediate effects on the actual physical activity behavior. METHODS: The NoHoW Toolkit (TK), a digital intervention developed to support long-term weight loss maintenance, was evaluated in a 2 x 2 factorial randomized controlled trial. The TK contained various modules based on behavioral self-regulation and motivation theories, as well as contextual emotion regulation approaches, and involved continuous tracking of weight and physical activity through connected commercial devices (Fitbit Aria and Charge 2). Of the 4 trial arms, 2 had access to 2 modules directly targeting physical activity: a module for goal setting and action planning (Goal) and a module for identifying barriers and coping planning (Barriers). Module visits and completion were determined based on TK log files and time spent in the module web page. Seven physical activity metrics (steps; activity; energy expenditure; fairly active, very active and total active minutes; and distance) were compared before and after visiting and completing the modules to examine whether the modules had immediate or sustained effects on physical activity. Immediate effect was determined based on 7-day windows before and after the visit, and sustained effects were evaluated for 1 to 8 weeks after module completion. RESULTS: Out of the 811 participants, 498 (61.4%) visited the Goal module and 406 (50.1%) visited the Barriers module. The Barriers module had an immediate effect on very active and total active minutes (very active minutes: before median 24.2, IQR 10.4-43.0 vs after median 24.9, IQR 10.0-46.3; P=.047; total active minutes: before median 45.1, IQR 22.9-74.9 vs after median 46.9, IQR 22.4-78.4; P=.03). The differences were larger when only completed Barriers modules were considered. The Barriers module completion was also associated with sustained effects in fairly active and total active minutes for most of the 8 weeks following module completion and for 3 weeks in very active minutes. CONCLUSIONS: The Barriers module had small, significant, immediate, and sustained effects on active minutes measured by a wrist-worn activity tracker. Future interventions should pay attention to assessing barriers and planning coping mechanisms to overcome them. TRIAL REGISTRATION: ISRCTN Registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328.

Users' Experiences With the NoHoW Web-Based Toolkit With Weight and Activity Tracking in Weight Loss Maintenance: Long-term Randomized Controlled Trial.

BACKGROUND: Digital behavior change interventions (DBCIs) offer a promising channel for providing health promotion services. However, user experience largely determines whether they are used, which is a precondition for effectiveness. OBJECTIVE: The primary aim of this study is to evaluate user experiences with the NoHoW Toolkit (TK)-a DBCI that targets weight loss maintenance-over a 12-month period by using a mixed methods approach and to identify the main strengths and weaknesses of the TK and the external factors affecting its adoption. The secondary aim is to objectively describe the measured use of the TK and its association with user experience. METHODS: An 18-month, 2×2 factorial randomized controlled trial was conducted. The trial included 3 intervention arms receiving an 18-week active intervention and a control arm. The user experience of the TK was assessed quantitatively through electronic questionnaires after 1, 3, 6, and 12 months of use. The questionnaires also included open-ended items that were thematically analyzed. Focus group interviews were conducted after 6 months of use and thematically analyzed to gain deeper insight into the user experience. Log files of the TK were used to evaluate the number of visits to the TK, the total duration of time spent in the TK, and information on intervention completion. RESULTS: The usability level of the TK was rated as satisfactory. User acceptance was rated as modest; this declined during the trial in all the arms, as did the objectively measured use of the TK. The most appreciated features were weekly emails, graphs, goal setting, and interactive exercises. The following 4 themes were identified in the qualitative data: engagement with features, decline in use, external factors affecting user experience, and suggestions for improvements. CONCLUSIONS: The long-term user experience of the TK highlighted the need to optimize the technical functioning, appearance, and content of the DBCI before and during the trial, similar to how a commercial app would be optimized. In a trial setting, the users should be made aware of how to use the intervention and what its requirements are, especially when there is more intensive intervention content. TRIAL REGISTRATION: ISRCTN Registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-029425.

Benefits to Performance and Well-Being of Nature-Based Exercise: A Critical Systematic Review and Meta-Analysis.

Prior reviews point to the superior benefits of exercising in nature vs in conventional indoor venues, particularly in terms of well-being. However, physical exercise performance, neither in terms of efficacy nor efficiency, has not been sufficiently addressed by past reviews of this topic. Therefore, we conducted both a systematic review and meta-analysis of the experimental literature that relates to differences in exercise performance and well-being between exercising in nature and in conventional indoor venues. Forty-nine relevant studies─the outcome data of which were used for the systematic review─were located within the Web of Science, PubMed, and Scopus databases. The meta-analyses, using data from twenty-four of the relevant studies, revealed no significant overall environmental effect on task performance efficacy outcomes (p = 0.100). For nature-based exercise, however, marginally positive cognitive performance outcomes (p = 0.059), lower ratings of perceived exhaustion (p = 0.001), and higher levels of vigor (p = 0.017) were observed, indicating higher performance efficiency. As for the effects of environment on well-being, positive affect was significantly higher for nature-based exercise (p = 0.000), while perceived stress was significantly higher for indoor exercise (p = 0.032). These results must, however, be interpreted with caution. High levels of bias and between-study heterogeneity were observed. Nonetheless, given several noticeable trends in the results, it may be that exercising in nature enhances the efficiency of exercise task performance to a greater extent than does indoor exercise.

A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study.

BACKGROUND: Many weight loss programs show short-term effectiveness, but subsequent weight loss maintenance is difficult to achieve. Digital technologies offer a promising means of delivering behavior change approaches at low costs and on a wide scale. The Navigating to a Healthy Weight (NoHoW) project, which was funded by the European Union's Horizon 2020 research and innovation program, aimed to develop, test, and evaluate a digital toolkit designed to promote successful long-term weight management. The toolkit was tested in an 18-month, large-scale, international, 2×2 factorial (motivation and self-regulation vs emotion regulation) randomized controlled trial that was conducted on adults with overweight or obesity who lost ≥5% of their body weight in the preceding 12 months before enrollment into the intervention. OBJECTIVE: This paper aims to describe the development of the NoHoW Toolkit, focusing on the logic models, content, and specifications, as well as the results from user testing. METHODS: The toolkit was developed by using a systematic approach, which included the development of the theory-based logic models, the selection of behavior change techniques, the translation of these techniques into a web-based app (NoHoW Toolkit components), technical development, and the user evaluation and refinement of the toolkit. RESULTS: The toolkit included a set of web-based tools and inputs from digital tracking devices (smart scales and activity trackers) and modules that targeted weight, physical activity, and dietary behaviors. The final toolkit comprised 34 sessions that were distributed through 15 modules and provided active content over a 4-month period. The motivation and self-regulation arm consisted of 8 modules (17 sessions), the emotion regulation arm was presented with 7 modules (17 sessions), and the combined arm received the full toolkit (15 modules; 34 sessions). The sessions included a range of implementations, such as videos, testimonies, and questionnaires. Furthermore, the toolkit contained 5 specific data tiles for monitoring weight, steps, healthy eating, mood, and sleep. CONCLUSIONS: A systematic approach to the development of digital solutions based on theory, evidence, and user testing may significantly contribute to the advancement of the science of behavior change and improve current solutions for sustained weight management. Testing the toolkit by using a 2×2 design provided a unique opportunity to examine the effect of motivation and self-regulation and emotion regulation separately, as well as the effect of their interaction in weight loss maintenance.

Hair Cortisol Concentration, Weight Loss Maintenance and Body Weight Variability: A Prospective Study Based on Data From the European NoHoW Trial.

Several cross-sectional studies have shown hair cortisol concentration to be associated with adiposity, but the relationship between hair cortisol concentration and longitudinal changes in measures of adiposity are largely unknown. We included 786 adults from the NoHoW trial, who had achieved a successful weight loss of ≥5% and had a body mass index of ≥25 kg/m2 prior to losing weight. Hair cortisol concentration (pg/mg hair) was measured at baseline and after 12 months. Body weight and body fat percentage were measured at baseline, 6-month, 12-month and 18-month visits. Participants weighed themselves at home ≥2 weekly using a Wi-Fi scale for the 18-month study duration, from which body weight variability was estimated using linear and non-linear approaches. Regression models were conducted to examine log hair cortisol concentration and change in log hair cortisol concentration as predictors of changes in body weight, change in body fat percentage and body weight variability. After adjustment for lifestyle and demographic factors, no associations between baseline log hair cortisol concentration and outcome measures were observed. Similar results were seen when analysing the association between 12-month concurrent development in log hair cortisol concentration and outcomes. However, an initial 12-month increase in log hair cortisol concentration was associated with a higher subsequent body weight variability between month 12 and 18, based on deviations from a nonlinear trend (ß: 0.02% per unit increase in log hair cortisol concentration [95% CI: 0.00, 0.04]; P=0.016). Our data suggest that an association between hair cortisol concentration and subsequent change in body weight or body fat percentage is absent or marginal, but that an increase in hair cortisol concentration during a 12-month weight loss maintenance effort may predict a slightly higher subsequent 6-months body weight variability. Clinical Trial Registration: ISRCTN registry, identifier ISRCTN88405328.

Keep on running - a randomized controlled trial to test a digital evidence-based intervention for sustained adoption of recreational running: rationale, design and pilot feasibility study.

BACKGROUND: This paper describes the rationale, intervention development, study design and results from the pilot feasibility study of the Keep On Running (KOR) trial. KOR aims to test a web-based brief theory-based intervention, targeting maintenance of recreational running behavior over time (i.e. relapse preventing). METHODS: Intervention development was based both on Self-Determination Theory and on Self-Regulation Theory. As part of it, a pilot study was implemented (n=18) to measure intervention adherence and participant satisfaction in order to establish the feasibility and acceptability of the intervention toolkit. Furthermore, this pilot study was also used to test the feasibility and acceptability of the questionnaires selected to be part of the later RCT. RESULTS: Pilot intervention acceptability was good, but overall adherence was low. Features such as feedback and social sharing should be added to the toolkit. The main trial should lessen questionnaire length and include data from usual monitoring gadgets and apps (APIs). The protocol of the RCT was adjusted to test the efficacy of the refined final version of the intervention, and the RCT that will test it, contributing to the understanding of recreational running sustainability, allowing the optimization of future interventions aimed at physical activity promotion.