Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JITAI Combined with psychological intervention, Active Control.
- Who it may be relevant to
- Registry conditions: Overweight or Obesity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral JITAI Combined with psychological intervention
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 whi - Behavioral Active Control
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.
Primary outcome measures
- State negative affect [Time frame: 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]
- State Motivation [Time frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
- State Self-Efficacy [Time frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
- 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]
- State self-compassion [Time frame: 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]
- State acceptance [Time frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
- Self-serving interpretation of weight gain [Time frame: Whenever participants regain weight during the 6 month study period]
- Daily Calorie Tracking (Yes/No) [Time frame: Whenever participants skip a weigh-in or regain weight during the 6 month study period]
Secondary outcome measures (3)
- Mindfulness (Hypothesized intervention mediator) [Time frame: Mid-Treatment (3 months after baseline)]
- Acceptance (Hypothesized intervention mediator) [Time frame: Mid-Treatment (3 months after baseline)]
- Self-compassion (Hypothesized intervention mediator) [Time frame: Mid-Treatment (3 months after baseline)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Research Institute Community and Evaluation Services — Springfield
Identifiers
NCT: NCT07708064 · K01HL172254