Eating Mindfully to Prevent Weight Regain

Not Applicable

Completed

• Conditions: Weight Loss; Eating Behavior; Weight Gain; Obesity; Bariatric Surgery Candidate

• 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.

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-19
• Study Start: 2021-06-16
• Status Verified: 2022-10
• Primary Completion: 2023-05-08
• Study Completion: 2024-05-22
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

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