Obesity & OverweightNCT07228130
Microrandomized Trial to Optimize Use of Burden-reducing Self-monitoring Approaches in Behavioral Obesity Treatment
A study testing Online Behavioral Obesity Treatment, Full Dietary Self-monitoring and Reduced-frequency Dietary Self-monitoring in people with Obesity & Overweight, run by The Miriam Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Online Behavioral Obesity Treatment, Full Dietary Self-monitoring and Reduced-frequency Dietary Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- English language fluent and literate at the 6th grade level
- Body mass index (BMI) above 25 kg/m-squared
- Able to walk 2 city blocks without stopping
- Not currently participating in another weight loss program
- Not currently taking weight loss medication
- Has not lost ≥5% of body weight in the 6 months prior to enrolling
- Has not been pregnant within the 6 months prior to enrolling
- Does not plan to become pregnant within 12 months of enrolling
- Denies having a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
- Denies any medical condition that would affect the safety of participating in unsupervised physical activity
- Denies any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness
- Owns a smartphone compatible with study procedures and is willing to use it for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Weight Control and Diabetes Research Center of The Miriam Hospital & Brown University
Providence, Rhode Island, 02903
Assistant (Research), 4017938154, jthomas4@lifespan.org
About this study
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.
Read more
Participants will:
- Follow a 24-week online program for weight loss and health improvement
- Use the assigned self-monitoring strategy every two weeks
- Meet with the researchers periodically via online video call and provide research data by answering questions via periodic online surveys.
Read the detailed description
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:
- Full dietary SM: Recording all food and drink consumed, with calorie estimates, every day.
- Reduced-frequency dietary SM: Recording all food and drink consumed, with calorie estimates, on 3 days per week.
- Self-monitoring of dietary lapses only: Recording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk.
- Smartwatch-based SM of energy intake: Using a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors.
- Body weight SM only: Weighing daily using a smart scale that automatically syncs data to the online treatment platform.
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.
- Conditions
- Obesity & Overweight
- Being tested
- Online Behavioral Obesity Treatment, Full Dietary Self-monitoring, Reduced-frequency Dietary Self-monitoring, Self-Monitoring of Dietary Lapses Only, Smartwatch-based Self-monitoring of Energy Intake
- Keywords
- Online, Obesity, Weight Loss, Diet, Physical Activity
- Medical subject headings
- Obesity, Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Behavioral Obesity TreatmentBehavioural
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.
Full Dietary Self-monitoringBehavioural
Recording all food and drink consumed, with calorie estimates, every day.
Reduced-frequency Dietary Self-monitoringBehavioural
Recording all food and drink consumed, with calorie estimates, on 3 days per week.
Self-Monitoring of Dietary Lapses OnlyBehavioural
Recording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk.
Smartwatch-based Self-monitoring of Energy IntakeBehavioural
Using a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors.
Self-monitoring of Body Weight OnlyBehavioural
Weighing daily using a smart scale that automatically syncs data to the online treatment platform.
| Study group | Role | What they receive |
|---|---|---|
| Online Behavioral Obesity Treatment with Full Dietary Self-monitoring | Experimental | The Online Behavioral Obesity Treatment intervention combined with the Full Dietary Self-monitoring intervention. Receives: Behavioral: Online Behavioral Obesity Treatment; Behavioral: Full Dietary Self-monitoring |
| Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring | Experimental | The Online Behavioral Obesity Treatment intervention combined with the Reduced-frequency Dietary Self-monitoring intervention. Receives: Behavioral: Online Behavioral Obesity Treatment; Behavioral: Reduced-frequency Dietary Self-monitoring |
| Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only | Experimental | The Online Behavioral Obesity Treatment intervention combined with the Self-Monitoring of Dietary Lapses Only intervention. Receives: Behavioral: Online Behavioral Obesity Treatment; Behavioral: Self-Monitoring of Dietary Lapses Only |
| Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake | Experimental | The Online Behavioral Obesity Treatment intervention combined with the Smartwatch-based Self-monitoring of Energy Intake intervention. Receives: Behavioral: Online Behavioral Obesity Treatment; Behavioral: Smartwatch-based Self-monitoring of Energy Intake |
| Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only | Experimental | The Online Behavioral Obesity Treatment intervention combined with the Self-monitoring of Body Weight Only intervention. Receives: Behavioral: Online Behavioral Obesity Treatment; Behavioral: Self-monitoring of Body Weight Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Self-Monitoring
Number of days on which the assigned self-monitoring strategy was used
Measured: 24 weeks
Weight Change
Weight measured in kg on the provided home scale
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 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").
Measured: 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?").
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start7 Jan 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The interventional model is a micro-randomized trial, which involves sequential (within-subject) randomization to different self-monitoring approaches throughout behavioral obesity treatment. Each participant will receive a 24-week online behavioral obesity treatment program and will be randomized to one of five SM strategies every two weeks, resulting in a total of 12 randomizations per participant.
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graham Thomas, PhD, Principal investigator, The Miriam HospitalStephanie Goldstein, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228130
- Sponsor's protocol ID
- R01DK136216
- Other IDs
- R01DK136216
- Status last verified
- Feb 2026
- First submitted
- 11 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microrandomized Trial to Optimize Use of Burden-reducing Self-monitoring Approaches in Behavioral Obesity Treatment
- ClinicalTrials.gov ID
- NCT07228130
- Acronym / sponsor ID
- R01DK136216
- Conditions
- Obesity & Overweight
- Keywords
- Online, Obesity, Weight Loss, Diet, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Follow a 24-week online program for weight loss and health improvement
- Use the assigned self-monitoring strategy every two weeks
- Meet with the researchers periodically via online video call and provide research data by answering questions via periodic online surveys.
Detailed description
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:
- Full dietary SM: Recording all food and drink consumed, with calorie estimates, every day.
- Reduced-frequency dietary SM: Recording all food and drink consumed, with calorie estimates, on 3 days per week.
- Self-monitoring of dietary lapses only: Recording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk.
- Smartwatch-based SM of energy intake: Using a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors.
- Body weight SM only: Weighing daily using a smart scale that automatically syncs data to the online treatment platform.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The interventional model is a micro-randomized trial, which involves sequential (within-subject) randomization to different self-monitoring approaches throughout behavioral obesity treatment. Each participant will receive a 24-week online behavioral obesity treatment program and will be randomized to one of five SM strategies every two weeks, resulting in a total of 12 randomizations per participant.
| Arm | Type | Receives |
|---|---|---|
| Online Behavioral Obesity Treatment with Full Dietary Self-monitoring | Experimental | Behavioral: Online Behavioral Obesity Treatment, Behavioral: Full Dietary Self-monitoringThe Online Behavioral Obesity Treatment intervention combined with the Full Dietary Self-monitoring intervention. |
| Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring | Experimental | Behavioral: Online Behavioral Obesity Treatment, Behavioral: Reduced-frequency Dietary Self-monitoringThe Online Behavioral Obesity Treatment intervention combined with the Reduced-frequency Dietary Self-monitoring intervention. |
| Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only | Experimental | Behavioral: Online Behavioral Obesity Treatment, Behavioral: Self-Monitoring of Dietary Lapses OnlyThe Online Behavioral Obesity Treatment intervention combined with the Self-Monitoring of Dietary Lapses Only intervention. |
| Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake | Experimental | Behavioral: Online Behavioral Obesity Treatment, Behavioral: Smartwatch-based Self-monitoring of Energy IntakeThe Online Behavioral Obesity Treatment intervention combined with the Smartwatch-based Self-monitoring of Energy Intake intervention. |
| Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only | Experimental | Behavioral: Online Behavioral Obesity Treatment, Behavioral: Self-monitoring of Body Weight OnlyThe Online Behavioral Obesity Treatment intervention combined with the Self-monitoring of Body Weight Only intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Behavioral Obesity TreatmentThe 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. | Behavioural | Online Behavioral Obesity Treatment with Full Dietary Self-monitoring, Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring, Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only, Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only, Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake |
| Full Dietary Self-monitoringRecording all food and drink consumed, with calorie estimates, every day. | Behavioural | Online Behavioral Obesity Treatment with Full Dietary Self-monitoring |
| Reduced-frequency Dietary Self-monitoringRecording all food and drink consumed, with calorie estimates, on 3 days per week. | Behavioural | Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring |
| Self-Monitoring of Dietary Lapses OnlyRecording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk. | Behavioural | Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only |
| Smartwatch-based Self-monitoring of Energy IntakeUsing a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors. | Behavioural | Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake |
| Self-monitoring of Body Weight OnlyWeighing daily using a smart scale that automatically syncs data to the online treatment platform. | Behavioural | Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only |
Primary outcome
Adherence to Self-Monitoring
Time frame: 24 weeks
Number of days on which the assigned self-monitoring strategy was used
Weight Change
Time frame: 24 weeks
Weight measured in kg on the provided home scale
3 secondary outcomes
Perceived Burden of Assigned Self-Monitoring Approach
Time frame: 24 weeks
Motivation to Engage in Self-Monitoring
Time frame: 24 weeks
Satisfaction With Assigned Self-Monitoring Approach
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Graham Thomas, PhD principal investigator
The Miriam Hospital
Stephanie Goldstein, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Behavioral Obesity Treatment, Full Dietary Self-monitoring and Reduced-frequency Dietary Self-monitoring in people with Obesity & Overweight, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Eisel Research Project Coordinator (401-793-8283, tech2trackstudy@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Self-Monitoring (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.