Eating Mindfully to Prevent Weight Regain (EMPWR)

October 12, 2022 updated by: Tanya Halliday, University of Utah

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

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Measured via calibrated digital scale
Measured at baseline, post intervention(Week 8), and 6 month follow up
Changes in Body Composition
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Measured via BodPod
Measured at baseline, post intervention(Week 8), and 6 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Food-Related Behaviors
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Evaluated via brief the Ways of Savoring Questionnaire
Measured at baseline, post intervention(Week 8), and 6 month follow up
Changes in Ad libitum Energy Intake - Free Living
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
3 days of free-living ad libitum energy intake (via self-report)
Measured at baseline, post intervention(Week 8), and 6 month follow up
Changes in Food-Related Behaviors
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Evaluated via Three-Factor Eating Questionnaire
Measured at baseline, post intervention(Week 8), and 6 month follow up
Changes in Food-Related Behaviors
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Evaluated via the Weight Efficacy Lifestyle Questionnaire
Measured at baseline, post intervention(Week 8), and 6 month follow up
Changes in Food-Related Behaviors
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Evaluated via the Food Craving Inventory
Measured at baseline, post intervention(Week 8), and 6 month follow up
Changes in Food-Related Behaviors
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Evaluated via the Multidimensional Assessment of Interoceptive Awareness
Measured at baseline, post intervention(Week 8), and 6 month follow up
Change in Ad libitum Energy Intake - In lab
Time Frame: Measured at baseline, post intervention(Week 8), and 6 month follow up
In lab ad libitum buffet lunch (via weigh and measure methodology)
Measured at baseline, post intervention(Week 8), and 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Tanya Halliday, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

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 (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00136609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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