Overweight or Obesity
Conditions
Keywords
just-in-time adaptive interventions, weight regain, self-weighing, self-compassion, acceptance-based behavioral treatments, mindfulness, behavioral weight loss
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.
Interventions
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.
BEHAVIORALActive 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.
Sponsors
ORI Community and Evaluation Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State negative affect | 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. |
| State shame | 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. |
| State Motivation | 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. |
| State Self-Efficacy | 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. |
| Current confidence in the effectiveness of weight control behaviors | 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. |
| State self-compassion | 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. |
| State mindfulness | 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. |
| State acceptance | 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. |
| Self-serving interpretation of weight gain | 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. |
| Daily Calorie Tracking (Yes/No) | Whenever participants skip a weigh-in or regain weight during the 6 month study period | Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no). |
| Daily MVPA | 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. |
| Likelihood of weighing in the following day | Whenever participants skip a weigh-in or regain weight during the 6 month study period | Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no). |
| Weight change | End of treatment (6 months after baseline) | Using participants' weights from a wireless scale, their percent weight change from the beginning to the end of the study period will be calculated. |
| Intervention acceptability | End of treatment (6 months after baseline) | 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. |
| Calorie Tracking Frequency | 6 months (duration of study period) | The number of days that participants logged their calories (at least 800 calories) using a dietary tracking app during the study period. |
| Average Weekly MVPA | 6 months (duration of study period) | Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period. |
| Frequency of Weighing In | 6 months (duration of study period) | Total number of days that participants weighed themselves on a wireless smart scale during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness (Hypothesized intervention mediator) | 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. |
| Acceptance (Hypothesized intervention mediator) | 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. |
| Self-compassion (Hypothesized intervention mediator) | Mid-Treatment (3 months after baseline) | 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. |
Countries
United States
Contacts
CONTACTCharlotte Hagerman, PhD
Outcome results
None listed