Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Marques MM

PROVIDER: S-EPMC8686406 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionObesity and associated diseases place a severe burden on healthcare systems. Behavioural interventions for weight loss (WL) are successful in the short term but often result in weight regain over time. Self-regulation of eating and activity behaviours may significantly enhance weight loss maintenance (WLM) and may be effectively augmented by contextual behavioural approaches to emotion regulation. The NoHoW trial tests the efficacy of a theoretically informed, evidence-based digital toolkit using a mobile-enabled website, activity trackers and Wi-Fi scales for WLM aiming to target (1) self-regulation and motivation, and (2) emotion regulation in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial body mass index (BMI) ≥25 kg/m2).Methods and analysisThe study is an 18-month, 3-centre, 2×2 factorial single-blind, randomised controlled trial, which recruited 1627 participants achieving ≥5% WL between March 2017 and March 2018. Participants are randomly allocated to one of four arms: (1) self-monitoring only (self-weighing and activity tracker), (2) self-regulation and motivation, (3) emotion regulation or (4) combined self-regulation, motivation and emotion regulation. Participants attend four clinical investigation days at 0, 6, 12 and 18 months and are instructed to use the digital toolkit for 18 weeks during the first 6 months and at their discretion for the remaining 12 months. The primary outcome is change in weight (kg) at 12 months from baseline. Secondary outcomes are body composition (eg, bioimpedance analysis), health biomarkers (glycated haemoglobin, lipids, blood pressure, hair cortisol), dietary intake, physical activity, sleep, motivational, self-regulatory, emotion regulatory moderators/mediators of WLM, engagement, user experience, acceptability and cost-effectiveness of the interventions.Ethics and disseminationEthical approval was granted by Institutional Ethics Committees at the Universities of Leeds (17-0082; 27 February 2017), Lisbon (17/2016; 20 February 2017) and Capital Region of Denmark (H-16030495, 8 March 2017). Results will be published in scientific journals.Trial registration numberISRCTN88405328.

Project description:BackgroundDigital health promotion programs tailored to the individual are a potential cost-effective and scalable solution to enable self-management and provide support to people with excess body weight. However, solutions that are widely accessible, personalized, and theory- and evidence-based are still limited.ObjectiveThis study aimed to develop a digital behavior change program, Choosing Health, that could identify modifiable predictors of weight loss and maintenance for each individual and use these to provide tailored support.MethodsWe applied an Intervention Mapping protocol to design the program. This systematic approach to develop theory- and evidence-based health promotion programs consisted of 6 steps: development of a logic model of the problem, a model of change, intervention design and intervention production, the implementation plan, and the evaluation plan. The decisions made during the Intervention Mapping process were guided by theory, existing evidence, and our own research-including 4 focus groups (n=40), expert consultations (n=12), and interviews (n=11). The stakeholders included researchers, public representatives (including individuals with overweight and obesity), and experts from a variety of relevant backgrounds (including nutrition, physical activity, and the health care sector).ResultsFollowing a structured process, we developed a tailored intervention that has the potential to reduce excess body weight and support behavior changes in people with overweight and obesity. The Choosing Health intervention consists of tailored, personalized text messages and email support that correspond with theoretical domains potentially predictive of weight outcomes for each participant. The intervention content includes behavior change techniques to support motivation maintenance, self-regulation, habit formation, environmental restructuring, social support, and addressing physical and psychological resources.ConclusionsThe use of an Intervention Mapping protocol enabled the systematic development of the Choosing Health intervention and guided the implementation and evaluation of the program. Through the involvement of different stakeholders, including representatives of the general public, we were able to map out program facilitators and barriers while increasing the ecological validity of the program to ensure that we build an intervention that is useful, user-friendly, and informative. We also summarized the lessons learned for the Choosing Health intervention development and for other health promotion programs.International registered report identifier (irrid)RR2-10.1136/bmjopen-2020-040183.

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