Eating Mindfully to Prevent Weight Regain
- Conditions
- Weight LossEating BehaviorWeight GainObesityBariatric Surgery Candidate
- Interventions
- Behavioral: Mindfulness Orientated Recovery EnhancementBehavioral: Control Intervention
- Registration Number
- NCT04847843
- Lead Sponsor
- University of Utah
- Brief Summary
The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.
- Detailed Description
Specific Aim 1: Determine the effect of MORE on weight loss maintenance.
Hypothesis:
MORE will result in less weight regain compared to CON after the 8-week intervention, and benefits will be sustained after 6-month of follow-up.
Specific Aim 2:
Determine the effect of MORE on reward-related behavioral processes (e.g., food cravings) and ad libitum energy intake.
Hypothesis:
MORE group will demonstrate changes in eating behaviors and energy intake associated with preventing weight regain compared to CON immediately after MORE and after 6-months of follow-up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Age 18-65
- Bariatric Surgery patients: 12-18 months post-operation.
- Medical weight loss patients: patients of the bariatric weight loss clinic, weight loss of 7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to intentional weight loss; stable for 3 months on medications.
- Lifestyle weight loss: weight loss of 7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to intentional weight loss.
- Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease; cancer treatment in past 5 years; untreated thyroid disease or other medical condition affecting weight or energy metabolism; severe food allergies; women who are pregnant, lactating, or planning pregnancy during participation in the trial; active psychiatric issues
- Additional criteria specific to patients with history of bariatric surgery: <12 months post-op; weight regain of >5% of body mass postoperation; history of admittance to rehabilitation facility; history of post-op complications that require recent inpatient management; patients who were required to stay in the hospital >1 week post-op; revision surgery patients; heart failure patients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness Orientated Recovery Enhancement (MORE) Intervention Mindfulness Orientated Recovery Enhancement 8-week MORE intervention adapted for preventing weight regain Control Intervention Control Intervention 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program.
- Primary Outcome Measures
Name Time Method Changes in Body Composition Measured at baseline, post intervention(Week 8), and 6 month follow up Measured via BodPod
Changes in Body Weight Measured at baseline, post intervention(Week 8), and 6 month follow up Measured via calibrated digital scale
- Secondary Outcome Measures
Name Time Method Change in Ad libitum Energy Intake - In lab Measured at baseline, post intervention(Week 8), and 6 month follow up In lab ad libitum buffet lunch (via weigh and measure methodology)
Changes in Food-Related Behaviors Measured at baseline, post intervention(Week 8), and 6 month follow up Evaluated via the Multidimensional Assessment of Interoceptive Awareness
Changes in Ad libitum Energy Intake - Free Living Measured at baseline, post intervention(Week 8), and 6 month follow up 3 days of free-living ad libitum energy intake (via self-report)
Trial Locations
- Locations (1)
University of Utah
🇺🇸Salt Lake City, Utah, United States