Eating Mindfully to Prevent Weight Regain (EMPWR)

Targeting Maladaptive Eating Behaviors With Mindfulness-based Training to Prevent Weight Regain

The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Weight Gain; Bariatric Surgery Candidate; Eating Behavior
• Intervention / Treatment: Behavioral: Mindfulness Orientated Recovery Enhancement; Behavioral: Control Intervention

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., disinhibition, restraint, hedonic hunger).

Hypothesis:

MORE group will demonstrate changes in eating behaviors associated with preventing weight regain compared to CON immediately after MORE and after 6-months of follow-up.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Orientated Recovery Enhancement (MORE) Intervention; 8-week MORE intervention adapted for preventing weight regain	Behavioral: Mindfulness Orientated Recovery Enhancement; The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing.; Other Names: MORE
Active Comparator: Control Intervention; 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program.	Behavioral: Control Intervention; The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body Weight	Body weight (kg) measured using a calibrated digital scale at three time points: baseline and 6 month follow up. Outcome measure was calculated by subtracting baseline weight from 6 month weigh. Lower value indicates greater weight loss.	Baseline and 6 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ways of Savoring Checklist (WOSC).	Four questions from Bryant and Veroffs Ways of Savoring Checklist (WOSC) were used to assess momentary sensory-perceptual sharpening (ex 'I tried to intensify the moment by focusing on it') and intensifying positive emotional reactions to positive events as 'amplifying' savoring (ex. 'In the last week, I enjoyed the little things in life more fully'). The instrument uses a 5-point Likert scale (ranging from 0 = Strongly Disagree to 5 = Strongly Agree). Scale Range: 4-20 Higher scores on the WOSC indicate a stronger perceived ability to savor positive experiences.	6-month follow-up
Dietary Restraint	Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 20 questions about restraint. Each item is scored either 0 or 1; therefore, the range is 0-20, with higher scores indicating greater levels of dietary restraint.	6 month follow up
Dietary Disinhibition	Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 16 items about disinhibition. Each item is scored either 0 or 1; therefore, the range is 0-16, with higher levels indicating greater levels of dietary disinhibition.	6 month follow-up
Interoceptive Awareness	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a self-report instrument utilizing a 6-point Likert scale (ranging from 0 = Never to 5 = Always). Scale Range: 0-55 Higher scores on the MAIA indicate higher ability of interoceptive bodily awareness.	6 month follow up
Hedonic Hunger	Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 15 items about general levels of hunger. Each item is scored either 0 or 1; therefore, the range is 0-15, with higher scores indicating greater levels of hedonic hunger.	6 months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Tanya Halliday, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): May 8, 2023
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness; Weight loss maintenance; Appetite Regulation; Weight regain prevention; mindfulness orientated recovery enhancement
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Behavior, Animal; Obesity; Weight Loss; Weight Gain; Feeding Behavior
• Other Study ID Numbers: 0132961; KL2TR002539 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No