UNASSIGNED: Physical inactivity is associated with health risks, contributing to various diseases and all-cause mortality. Despite recommendations for regular physical activity (PA), many adults remain inactive, influenced by socioeconomic and environmental factors. Digital interventions, particularly web-based PA programs, offer promising possibilities to promote PA across populations. These programs vary in their effectiveness, reflecting differences in design, user engagement, and behavior change techniques employed.
UNASSIGNED: This study evaluates the effectiveness of the 12-week multimodal web-based TKFitnessCoach. The PA online program is part of the TK-HealthCoach. This study investigates the program\'s impact on self-reported PA levels, goal attainment, healthrelated quality of life, body weight, and eating behavior, comparing an interactive personalized web-based intervention and non-interactive web-based health information.
UNASSIGNED: In a randomized controlled trial (RCT), participants were allocated to either the intervention group (IG), receiving access to the interactive TK-FitnessCoach, or the control group (CG) that was provided a static website with evidence-based information on PA. The study targeted a German-speaking adult population interested in improving health behavior. Data was assessed at T0 (beginning of the study), T1 (postintervention), T2, 6 months, and T3, 12 months follow-ups, focusing on self-reported PA at T3 and on various secondary outcomes.
UNASSIGNED: We achieved equally distributed sociodemographics in both the IG and the CG with a mean age of 42.8 (IG), resp. 43.1 years (CG), and female participants of 76.1 % (IG), resp. 74.7 % (CG). PA at baseline was 277.9 min/week in the IG and 273.3 min/week in the CG. Both, the IG (n = 1153 in the Intention-to-treat (ITT) dataset) and CG (n = 1177 in the ITT dataset) exhibited significant increases in PA over time (IG(T3-T0) = 72.92 min/week; CG(T3-T0) = 74.12 min/week).However, the study did not find significant differences in the effectiveness of the interactive TK-FitnessCoach compared to the non-interactive control in terms of improving PA and related health outcomes. The intensity of using the TK-FitnessCoach was not associated with PA.
UNASSIGNED: Both programs were effective in promoting PA among adults, with no significant differences observed between the two RCT groups. This highlights the potential of digital interventions in addressing physical inactivity, suggesting that the effectiveness of such programs may not solely depend on their interactivity but also on the quality and relevance of the information provided. Further research is needed to explore optimization strategies for such interventions, especially for persons with low PA, including user engagement, behavior change techniques, and the integration of objective PA tracking methods.
UNASSIGNED: German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249.

Physical activity promotes health and longevity after metabolic/bariatric surgery (MBS), but most patients do not meet recommended levels. The Gaining Optimism After weight Loss Surgery (GOALS) Project was a positive psychological intervention designed to address common emotional barriers to physical activity in patients who have recently undergone MBS (e.g., low confidence around exercise, internalized weight bias, fear of injury) and use motivational interviewing and standard behavior change techniques (e.g., self-monitoring) to increase physical activity. This single-arm proof-of-concept trial was designed to refine the intervention, test feasibility and acceptability, and explore pre-post changes in behavioral and psychological outcomes. Participants were 12 adults 6-12 months post-MBS (M age of 46, 58% female, 67% non-Hispanic white). GOALS was a 10-week telephone counseling program that introduced new positive psychological skills and physical activity topics each week. Participants tracked physical activity with a Fitbit and set weekly goals. Results showed that the intervention was feasible (85% of sessions completed) and acceptable (average participant ratings of session ease and utility above 8.0 on a 0-10 scale). There were medium-to-large effect size improvements in physical activity and psychological well-being (e.g., depressive symptoms). The GOALS intervention will next be tested in a pilot randomized controlled trial with longer-term follow-up to assess its effect more robustly.

BACKGROUND: Behavioral activation (BA) is an evidence-based treatment for depression that fosters engagement in values-based activities to increase access to positive reinforcement. Depressed mood has been shown to hinder smoking cessation.
OBJECTIVE: This study determined the feasibility and preliminary efficacy of a mobile app to motivate smokers to quit by using BA and integrating motivational messages to quit smoking.
METHODS: Adult smokers (N=56; mean age 34.5, SD 9.52 years) who were not ready to quit smoking within 30 days were recruited from advertisements and randomized to either 8 weeks of the BA app (set 2 values-based activities per week+motivational messages+feedback on changes in smoking, mood, and values-based activities) or the control group (no app; received resources for quitting smoking). All participants completed the baseline and end-of-treatment web-based questionnaires. Controls also completed weekly web-based assessments, and BA app participants completed assessments through the app.
RESULTS: There were no dropouts and only 2 participants in each condition did not complete the end-of-treatment questionnaire. The results demonstrated that it is feasible to recruit smokers who are unmotivated to quit into a smoking cessation induction trial: 86% (57/66) of eligible participants were randomized (BA app: n=27; control: n=29). Participants reported high levels of satisfaction: 80% (20/25) of participants said they would recommend the BA app, there were moderate-to-high scores on the Mobile App Rating Scale, and 88% (22/25) of participants rated the app 3 stars or higher (out of 5). There were high levels of BA app engagement: 96% (26/27) of participants planned activities, and 67% (18/27) of participants planned 7 or more activities. High engagement was found even among those who were at the highest risk for continued smoking (low motivation to quit, low confidence to quit, and high negative affect). The results provided support for the hypothesized relationships between BA constructs: greater pleasant activity completion was associated with greater positive affect (b=0.37, SE 0.21; 95% CI -0.05 to 0.79; P=.08), and greater positive affect tended to predict fewer cigarettes smoked the next day (b=-0.19, SE 0.10; 95% CI -0.39 to 0.01; P=.06). Additionally, a greater number of activities planned was associated with lower negative affect (b=-0.26, SE 0.15; 95% CI -0.55 to 0.04; P=.09). Overall, 16% (4/25) of BA app participants set a quit date versus 4% (1/27) among controls, and there were promising (but not significant) trends for motivation and confidence to quit.
CONCLUSIONS: The findings suggest that a mobile app intervention can be made appealing to smokers who are unmotivated to quit by focusing on aspects most important to them, such as mood management. This theory-based intervention has shown some initial support for the underlying theoretical constructs, and further efficacy testing is warranted in a fully powered trial.

OBJECTIVE: This study aimed to assess the feasibility and effects of a simple-to-implement multicomponent intervention to reduce sedentary time of office workers.
METHODS: Six groups of eight to ten office workers took part in the two-week Leicht Bewegt intervention. Participants completed questionnaires at baseline (T0, n = 52), after 2 weeks (T1, n = 46), and after 5 weeks (T2, n = 38), including subjective sedentary measures and social-cognitive variables based on the health action process approach (HAPA). Objective sedentary measures were obtained using activPAL trackers.
RESULTS: The intention to reduce sedentary behavior during work increased significantly from T0 to T1. Participants\' objective and subjective sitting time decreased significantly from T0 to T1, corresponding to an average decrease per 8-h-workday of 55 min (d = - .66) or 74 min (d = - 1.14), respectively. This reduction persisted (for subjective sitting time) at T2 (d = - 1.08). Participants indicated a high satisfaction with the intervention.
CONCLUSIONS: The Leicht Bewegt intervention offers a feasible and effective opportunity to reduce sedentary behavior at work. Randomized controlled trials including longer follow-up time periods are needed to validate its benefits in different workplaces.

BACKGROUND: Women with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period.
OBJECTIVE: We aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes.
METHODS: IMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant\'s needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses.
RESULTS: The study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024.
CONCLUSIONS: This is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions.
BACKGROUND: Australian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true.
UNASSIGNED: DERR1-10.2196/51431.

Reducing household air pollution (HAP) to levels associated with health benefits requires nearly exclusive use of clean cooking fuels and abandonment of traditional biomass fuels.
The Household Air Pollution Intervention Network (HAPIN) trial randomized 3,195 pregnant women in Guatemala, India, Peru, and Rwanda to receive a liquefied petroleum gas (LPG) stove intervention (n = 1,590), with controls expected to continue cooking with biomass fuels (n = 1,605). We assessed fidelity to intervention implementation and participant adherence to the intervention starting in pregnancy through the infant\'s first birthday using fuel delivery and repair records, surveys, observations, and temperature-logging stove use monitors (SUMs).
Fidelity and adherence to the HAPIN intervention were high. Median time required to refill LPG cylinders was 1 day (interquartile range 0-2). Although 26% (n = 410) of intervention participants reported running out of LPG at some point, the number of times was low (median: 1 day [Q1, Q3: 1, 2]) and mostly limited to the first four months of the COVID-19 pandemic. Most repairs were completed on the same day as problems were reported. Traditional stove use was observed in only 3% of observation visits, and 89% of these observations were followed up with behavioral reinforcement. According to SUMs data, intervention households used their traditional stove a median of 0.4% of all monitored days, and 81% used the traditional stove < 1 day per month. Traditional stove use was slightly higher post-COVID-19 (detected on a median [Q1, Q3] of 0.0% [0.0%, 3.4%] of days) than pre-COVID-19 (0.0% [0.0%, 1.6%] of days). There was no significant difference in intervention adherence pre- and post-birth.
Free stoves and an unlimited supply of LPG fuel delivered to participating homes combined with timely repairs, behavioral messaging, and comprehensive stove use monitoring contributed to high intervention fidelity and near-exclusive LPG use within the HAPIN trial.

Embodied Conversational Agents (ECAs) can increase user engagement and involvement and can strengthen the effect of an intervention on health outcomes that is provided via an ECA. However, evidence regarding the effectiveness of ECAs on health outcomes is still limited. In this article, we report on a study that has the goal to identify the effect of a match between a health topic and the ECAs\' appearance on ratings of personality characteristics, persuasiveness and intention to use. We report on an online experiment with three different ECAs and three different health topics, conducted among 732 older adults. We triangulated the quantitative results with qualitative insights from a focus group. The results reveal that older adults prefer an ECA that has an appearance matching a certain health topic, resulting in higher ratings on persuasiveness and intention to use. Personality characteristics should be measured embedded within a health topic, but are not rated higher because of a match. We furthermore provide guidelines for designing the content of the ECA.

The prevalence of non-communicable diseases, such as diabetes and cardiovascular disease, is rising in low- and middle-income countries (LMICs). Health behavior change (HBC) interventions such as the widely used Diabetes Prevention Program (DPP) are effective at reducing chronic disease risk, but have not been adapted for LMICs. Leveraging mobile health (mHealth) technology such as text messaging (SMS) to enhance reach and participant engagement with these interventions has great promise, yet we lack evidence-informed approaches to guide the integration of SMS specifically to support HBC interventions in LMIC contexts. To address this gap, we integrated guidance from the mHealth literature with expertise and first-hand experience to establish specific development steps for building and implementing SMS systems to support HBC programming in LMICs. Specifically, we provide real-world examples of each development step by describing our experience in designing and delivering an SMS system to support a culturally-adapted DPP designed for delivery in South Africa. We outline eight key SMS development steps, including: 1) determining if SMS is appropriate; 2) developing system architecture and programming; 3) developing theory-based messages; 4) developing SMS technology; 5) addressing international SMS delivery; 6) testing; 7) system training and technical support; and 8) cost considerations. We discuss lessons learned and extractable principles that may be of use to other mHealth and HBC researchers working in similar LMIC contexts.Trial registration Clinicaltrials.gov, NCT03342274 . Registered 10 November 2017.

UNASSIGNED: Reducing household air pollution (HAP) to levels associated with health benefits requires nearly exclusive use of clean cooking fuels and abandonment of traditional biomass fuels.
UNASSIGNED: The Household Air Pollution Intervention Network (HAPIN) trial randomized 3,195 pregnant women in Guatemala, India, Peru, and Rwanda to receive a liquefied petroleum gas (LPG) stove intervention (n=1,590), with controls expected to continue cooking with biomass fuels (n=1,605). We assessed fidelity to intervention implementation and participant adherence to the intervention starting in pregnancy through the infant\'s first birthday using fuel delivery and repair records, surveys, observations, and temperature-logging stove use monitors (SUMs).
UNASSIGNED: Fidelity and adherence to the HAPIN intervention were high. Median time required to refill LPG cylinders was 1 day (interquartile range 0-2). Although 26% (n=410) of intervention participants reported running out of LPG at some point, the number of times was low (median: 1 day [Q1, Q3: 1, 2]) and mostly limited to the first four months of the COVID-19 pandemic. Most repairs were completed on the same day as problems were reported. Traditional stove use was observed in only 3% of observation visits, and 89% of these observations were followed up with behavioral reinforcement. According to SUMs data, intervention households used their traditional stove a median of 0.4% of all monitored days, and 81% used the traditional stove <1 day per month. Traditional stove use was slightly higher post-COVID-19 (detected on a median [Q1, Q3] of 0.0% [0.0%, 3.4%] of days) than pre-COVID-19 (0.0% [0.0%, 1.6%] of days). There was no significant difference in intervention adherence pre- and post-birth.
UNASSIGNED: Free stoves and an unlimited supply of LPG fuel delivered to participating homes combined with timely repairs, behavioral messaging, and comprehensive stove use monitoring contributed to high intervention fidelity and near-exclusive LPG use within the HAPIN trial.

OBJECTIVE: To compare the effectiveness of a structured goal-setting and tailored follow-up rehabilitation intervention with existing rehabilitation in patients with rheumatic and musculoskeletal diseases.
METHODS: A pragmatic stepped-wedge cluster randomized trial.
METHODS: Eight rehabilitation centers in secondary healthcare, Norway.
METHODS: A total of 374 adults with rheumatic and musculoskeletal diseases were included in either the experimental (168) or the control group (206).
METHODS: A new rehabilitation intervention which comprised structured goal setting, action planning, motivational interviewing, digital self-monitoring of goal progress, and individual follow-up support after discharge according to patients\' needs and available resources in primary healthcare (the BRIDGE-intervention), was compared to usual care.
METHODS: Patient-reported outcomes were collected electronically on admission and discharge from rehabilitation, and after 2, 7, and 12 months. The primary outcome was patients\' goal attainment measured by the Patient Specific Functional Scale (0-10, 10 best) at 7 months. Secondary outcome measures included physical function (30-s Sit-To-Stand test), health-related quality of life (EQ-5D-5L-index), and self-assessed health (EQ-VAS). The main statistical analyses were performed on an intention-to-treat basis using linear mixed models.
RESULTS: No significant treatment effects of the BRIDGE-intervention were found for either primary (Patient Specific Functional Scale mean difference 0.1 [95% CI: -0.5, 0.8], p = 0.70), or secondary outcomes 7 months after rehabilitation.
CONCLUSIONS: The BRIDGE-intervention was not shown to be more effective than existing rehabilitation for patients with rheumatic and musculoskeletal diseases. There is still a need for more knowledge about factors that can improve the quality, continuity, and long-term health effects of rehabilitation for this patient group.