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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorORI Community and Evaluation Services

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: JITAI ConditionExperimental treatment 1 intervention
Group B: Active Control ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

State negative affect

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

Time frame
Whenever participants skip a weigh-in or regain weight during the 6 month study period
2

State shame

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

Time frame
Whenever participants skip a weigh-in or regain weight during the 6 month study period
3

State Motivation

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

Time frame
Whenever participants skip a weigh-in or regain weight during the 6 month study period
4

State Self-Efficacy

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

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

Secondary outcomes

1

Mindfulness (Hypothesized intervention mediator)

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.

Time frame
Mid-Treatment (3 months after baseline)
2

Acceptance (Hypothesized intervention mediator)

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.

Time frame
Mid-Treatment (3 months after baseline)
3

Self-compassion (Hypothesized intervention mediator)

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.

Time frame
Mid-Treatment (3 months after baseline)

Other outcomes

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