- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07708064
Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)
August 7, 2026 updated by: ORI Community and Evaluation Services
This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain.
Participants will be randomly assigned to one of two conditions.
In one condition, participants will receive brief exercises (e.g., written reflections, videos) sent to through a smartphone app immediately after they regain weight or miss a weigh-in.
These exercises will use mindfulness, acceptance, and self-compassion strategies to help participants stay motivated for their long term goals, even when weight regain feels demoralizing.
In the comparison condition, participants will receive weekly reminders of standard weight control strategies strategies.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charlotte Hagerman, PhD
- Phone Number: 14109372035
- Email: chagerman@ori.org
Study Locations
-
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Oregon
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Springfield, Oregon, United States, 97477
- Recruiting
- Oregon Research Institute Community and Evaluation Services
-
Contact:
- Charlotte Hagerman, PhD
- Phone Number: 4109372035
- Email: chagerman@ori.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Ages 18-70 years
- BMI of 25-50 kg/m2
- Current weight is 3% lower than their highest weight in the past 3 years
- Desire to maintain their weight or lose more
- Ability to engage in PA, as defined as being able to walk two full city blocks without stopping
- Smartphone and Internet access
- Successful completion of all enrollment procedures
- Ability to attend a workshop(s) on a Monday or Tuesday evening
Exclusion Criteria:
- History of bariatric surgery
- History of being diagnosed with an eating disorder
- Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months
- Enrolled in another formal weight loss/weight maintenance program
- Currently taking a GLP-1 medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: JITAI Condition
Participants in this condition will receive a 6-month weight loss maintenance intervention that uses mindfulness, acceptance, and self-compassion strategies to respond to weight regain.
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For six months, participants will receive a just-in-time adaptive interventions via a smartphone app immediately after they gain weight or they skip a weigh-in (according to a specific algorithm).
Interventions will engage participants in mindfulness, acceptance, and self-compassion-based (MASC) strategies through different modalities (e.g., writing exercises, videos, audio reflections).
They will take approximately 1-10 minutes.
Participants will also attend an introductory workshop, during which they will receive the instructions weigh daily, learn the importance of quickly responding to weight regain, and be introduced to MASC strategies.
They will also attend two booster workshops during the 6-month period.
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Active Comparator: Active Control Condition
Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.
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For six months, participants will receive weekly, automated messages via a smartphone app with reminders of standard behavioral weight control principles.
Participants will attend an introductory workshop, during which they will receive instructions to weigh daily and learn the importance of responding to weight regain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State negative affect
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their current negative affect.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
|
State shame
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their current shame.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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State Motivation
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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State Self-Efficacy
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their current self-efficacy.
|
Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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Current confidence in the effectiveness of weight control behaviors
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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State self-compassion
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
|
State mindfulness
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
|
State acceptance
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their state acceptance.
|
Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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Self-serving interpretation of weight gain
Time Frame: Whenever participants regain weight during the 6 month study period
|
Through ecological assessment surveys, participants will respond to a single item measuring their self-serving interpretation of the weight regain.
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Whenever participants regain weight during the 6 month study period
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Daily Calorie Tracking (Yes/No)
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no).
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Daily MVPA
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Likelihood of weighing in the following day
Time Frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no).
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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Calorie Tracking Frequency
Time Frame: 6 months (duration of study period)
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The number of days that participants logged their calories (at least 800 calories) using a dietary tracking app during the study period.
|
6 months (duration of study period)
|
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Average Weekly MVPA
Time Frame: 6 months (duration of study period)
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Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.
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6 months (duration of study period)
|
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Frequency of Weighing In
Time Frame: 6 months (duration of study period)
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Total number of days that participants weighed themselves on a wireless smart scale during the study period.
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6 months (duration of study period)
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Weight change
Time Frame: End of treatment (6 months after baseline)
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Using participants' weights from a wireless scale, their percent weight change from the beginning to the end of the study period will be calculated.
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End of treatment (6 months after baseline)
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Intervention acceptability
Time Frame: End of treatment (6 months after baseline)
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Intervention acceptability will be operationalized as the percent of participants who indicate that they are "satisfied" or "very satisfied" with the program on an anonymous survey that they complete during their individual interview.
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End of treatment (6 months after baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindfulness (Hypothesized intervention mediator)
Time Frame: Mid-Treatment (3 months after baseline)
|
Participants will self-report their mindfulness using the Awareness subscale of The Philadelphia Mindfulness Scale.
The range of scores is 1-5, with higher scores indicating greater mindfulness.
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Mid-Treatment (3 months after baseline)
|
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Acceptance (Hypothesized intervention mediator)
Time Frame: Mid-Treatment (3 months after baseline)
|
Participants will self-report their mindful acceptance using the Acceptance subscale of The Philadelphia Mindfulness Scale.
The range of scores is 1-5, with higher scores indicating greater mindful acceptance.
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Mid-Treatment (3 months after baseline)
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Self-compassion (Hypothesized intervention mediator)
Time Frame: Mid-Treatment (3 months after baseline)
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Participants will report their self-compassion using the Self-Compassion Scale Short Form.
Scores can range from 1 to 5, with higher scores indicating higher self-compassion.
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Mid-Treatment (3 months after baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
July 12, 2026
First Submitted That Met QC Criteria
July 12, 2026
First Posted (Actual)
July 16, 2026
Study Record Updates
Last Update Posted (Actual)
August 11, 2026
Last Update Submitted That Met QC Criteria
August 7, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01HL172254 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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