Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain

NCT07708064 | Recruiting

• 1 other identifier: K01HL172254
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight or Obesity

Keywords

just-in-time adaptive interventions; weight regain; self-weighing; self-compassion; acceptance-based behavioral treatments; mindfulness; behavioral weight loss

Outcome Measures

Primary Outcomes (17)

• State negative affect

  Through ecological assessment surveys, participants will respond to a single item measuring their current negative affect.

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• State shame

  Through ecological assessment surveys, participants will respond to a single item measuring their current shame.

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• State Motivation

  Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• State Self-Efficacy

  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

• Current confidence in the effectiveness of weight control behaviors

  Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• State self-compassion

  Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• State mindfulness

  Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• State acceptance

  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

• Self-serving interpretation of weight gain

  Through ecological assessment surveys, participants will respond to a single item measuring their self-serving interpretation of the weight regain.

  Whenever participants regain weight during the 6 month study period

• Daily Calorie Tracking (Yes/No)

  Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no).

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• Daily MVPA

  Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• Likelihood of weighing in the following day

  Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no).

  Whenever participants skip a weigh-in or regain weight during the 6 month study period

• Weight change

  Using participants' weights from a wireless scale, we will calculate their percent weight change from the beginning to the end of the study period.

  End of treatment (6 months after baseline)

• Intervention acceptability

  We will record 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.

  End of treatment (6 months after baseline)

• Calorie Tracking Frequency

  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)

• Average Weekly MVPA

  Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.

  6 months (duration of study period)

• Frequency of Weighing In

  Total number of days that participants weighed themselves on a wireless smart scale during the study period.

  6 months (duration of study period)

Secondary Outcomes (3)

• Mindfulness (Hypothesized intervention mediator)

  Mid-Treatment (3 months after baseline)

• Acceptance (Hypothesized intervention mediator)

  Mid-Treatment (3 months after baseline)

• Self-compassion (Hypothesized intervention mediator)

  Mid-Treatment (3 months after baseline)

Study Arms (2)

JITAI Condition

EXPERIMENTAL

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.

Behavioral: JITAI Combined with psychological intervention

Active Control Condition

ACTIVE COMPARATOR

Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.

Behavioral: Active Control

Interventions

JITAI Combined with psychological intervention BEHAVIORAL

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.

JITAI Condition

Active Control BEHAVIORAL

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.

Active Control Condition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ORI Community and Evaluation Services: lead

Study Sites (1)

Oregon Research Institute Community and Evaluation Services

Springfield, Oregon, 97477, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Charlotte Hagerman, PhD

CONTACT

14109372035; chagerman@ori.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (1)