An interventional study of Online Behavioral Obesity Treatment and Full Dietary Self-monitoring in Obesity & Overweight, sponsored by The Miriam Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment
This clinical trial is focused on testing dietary self-monitoring strategies used in behavioral obesity treatment. The goal is to determine which self-monitoring strategies are most useful for whom, at which points in treatment, and under what circumstances.
Researchers will provide a 24-week online behavioral obesity treatment program, and will randomize participants to use one of 5 dietary self-monitoring strategies every two weeks. The five strategies include: recording all food and drink consumed and corresponding energy intake (i.e., "calories") on 7 days per week; recording all food and drink consumed and corresponding energy intake (i.e., "calories") on 3 days per week; self-monitoring of dietary lapses (i.e. any eating/drinking likely to cause weight gain or put weight loss at risk); smartwatch-based monitoring of energy intake (i.e., "calories"); and self-monitoring of body weight only via smart scale.
Participants will:
This clinical trial is a 24-week micro-randomized trial (MRT) designed to optimize the use of dietary self-monitoring (SM) strategies during behavioral obesity treatment (BOT). Self-monitoring is considered the cornerstone of BOT because it enables individuals to regulate behaviors that influence energy balance and weight loss. However, adherence to traditional full dietary SM (i.e., recording all food and beverages consumed each day) declines rapidly over time due to its burden, leading to poorer weight loss outcomes.
To address this problem, this study evaluates five SM approaches that vary in intensity and burden:
All participants (N=275 adults with overweight or obesity, aged 18-70) will receive a 24-week evidence-based, online BOT. This BOT includes interactive multimedia lessons on nutrition, physical activity, and behavioral skills for weight management, with individualized calorie and activity goals, self-regulation training, and automated feedback. The only experimental manipulation is the self-monitoring approach assigned every two weeks.
At the start of treatment and every two weeks thereafter, participants will be randomly assigned to one of the five SM approaches (12 total randomizations per participant). Randomization probabilities favor assignment to full dietary SM at treatment initiation, then gradually equalize across approaches. At each randomization, participants will be notified of their new SM assignment and receive a brief online training for that approach. A member of the research team will conduct a short online video call to confirm comprehension and assist with troubleshooting.
Participants will complete study assessments remotely at baseline and 24 weeks via online video call and online surveys. They will be provided with study equipment, including a smart scale and a smartwatch (participants may use their own smartwatch if it is compatible with the study platform). All SM data (e.g., SM logs, smartwatch data, smart scale readings) will be automatically transferred to the secure BOT system. Participants will also complete brief questionnaires at each randomization point assessing perceived burden, motivation, satisfaction, and engagement with the assigned SM approach.
The co-primary outcomes are (1) SM adherence, defined as the number of days per two-week period that the participant completes ≥2 eating recordings (or weighs daily in the body-weight-only condition), and (2) objectively measured weight change (kg) via smart scale. Secondary outcomes include perceived burden, motivation, satisfaction with SM strategy, and platform engagement metrics.
This MRT design enables the research team to compare short-term (2-week) effects of each SM approach on adherence and weight loss, identify how these effects vary over time and across individual characteristics, and develop a data-driven algorithm that adaptively selects optimal SM approaches for future treatment. Reinforcement learning will be applied to the MRT data to construct an adaptive SM-selection algorithm capable of personalizing SM recommendations based on individual differences, social determinants of health, and ongoing treatment response.
This project will yield both broadly applicable recommendations (e.g., which SM approaches are generally most effective at different stages of treatment) and an adaptive algorithm to guide individualized SM strategies in future clinical and research settings. The findings are expected to enhance long-term adherence to self-monitoring and improve the effectiveness and scalability of behavioral obesity treatments delivered online.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 275 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →The Miriam Hospital is the lead sponsor of 182 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Online Behavioral Obesity Treatment intervention combined with the Full Dietary Self-monitoring intervention.
Behavioral: Online Behavioral Obesity Treatment · Behavioral: Full Dietary Self-monitoring
The Online Behavioral Obesity Treatment intervention combined with the Reduced-frequency Dietary Self-monitoring intervention.
Behavioral: Online Behavioral Obesity Treatment · Behavioral: Reduced-frequency Dietary Self-monitoring
The Online Behavioral Obesity Treatment intervention combined with the Self-Monitoring of Dietary Lapses Only intervention.
Behavioral: Online Behavioral Obesity Treatment · Behavioral: Self-Monitoring of Dietary Lapses Only
The Online Behavioral Obesity Treatment intervention combined with the Smartwatch-based Self-monitoring of Energy Intake intervention.
Behavioral: Online Behavioral Obesity Treatment · Behavioral: Smartwatch-based Self-monitoring of Energy Intake
The Online Behavioral Obesity Treatment intervention combined with the Self-monitoring of Body Weight Only intervention.
Behavioral: Online Behavioral Obesity Treatment · Behavioral: Self-monitoring of Body Weight Only
The online behavioral obesity treatment consists of: (a) 12 weekly multimedia lessons followed by 3 monthly lessons focused on behavioral skills for weight loss and weight loss maintenance; (b) online tools for goal setting, self-monitoring of diet, physical activity, and body weight; and (c) weekly feedback messages summarizing progress toward goals and providing support and problem-solving. Participants are given recommendations to help them set goals based on their self-monitoring condition (i.e., calorie goal, lapse goal, weight loss goal) and are guided to follow a healthy eating plan to achieve weight loss and health improvement. The physical activity goal is based on baseline activity level, with gradual progression from 50 minutes per week to 250 minutes per week of moderate-intensity activity (e.g., brisk walking). The program emphasizes evidence-based behavioral strategies including stimulus control, problem-solving, goal setting, and relapse prevention.
Recording all food and drink consumed, with calorie estimates, every day.
Recording all food and drink consumed, with calorie estimates, on 3 days per week.
Recording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk.
Using a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors.
Weighing daily using a smart scale that automatically syncs data to the online treatment platform.
Adherence to Self-Monitoring
Number of days on which the assigned self-monitoring strategy was used
Time frame: 24 weeks
Weight Change
Weight measured in kg on the provided home scale
Time frame: 24 weeks
Perceived Burden of Assigned Self-Monitoring Approach
Self-reported perceived burden of the self-monitoring approach used during the prior 2 weeks, assessed with items adapted from the User Burden Scale (e.g., "Using this self-monitoring method required too much mental effort"). Higher scores indicate greater perceived burden.
Time frame: 24 weeks
Motivation to Engage in Self-Monitoring
Self-reported motivation to adhere to the assigned SM approach, measured using adapted items from the Motivation for Weight Loss Scale (e.g., "I intend to self-monitor using the assigned strategy on most days over the next two weeks").
Time frame: 24 weeks
Satisfaction With Assigned Self-Monitoring Approach
Self-reported satisfaction with the assigned SM strategy, assessed using items adapted from the Diabetes Treatment Satisfaction Questionnaire (e.g., "How satisfied were you with this self-monitoring strategy?").
Time frame: 24 weeks
Plan to share: Yes — De-identified baseline data collected via online questionnaire, co-primary outcomes (i.e., participant adherence to SM conditions and weekly weights), data collected via the obesity treatment platform (e.g., website engagement), and data on treatment factors collected at 2-week intervals via questionnaire (e.g., perceived burden, satisfaction) will be shared with participants' consent. Identifiable and quasi-identifiable information will not be shared . Analyzed datasets along with analysis code and codebooks will be preserved and shared. Data will be made accessible via online repository at the time of associated publication(s) or the end of the performance period, whichever comes first, and they will remain publicly accessible as long as it is anticipated that they are useful for the larger research community, institutions, and/or broader public (to be determined by NIDDK-CR or VIVLI protocol).
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.