Eating Mindfully to Prevent Weight Regain

NCT04847843 | Completed Results

• 2 other identifiers: 0132961KL2TR002539
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Weight Gain; Eating Behavior; Obesity; Bariatric Surgery Candidate

Keywords

Appetite Regulation; Weight regain prevention; Weight loss maintenance; mindfulness; mindfulness orientated recovery enhancement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Ways of Savoring Checklist (WOSC).

  6-month follow-up

• Dietary Restraint

  6 month follow up

• Dietary Disinhibition

  6 month follow-up

• Interoceptive Awareness

  6 month follow up

• Hedonic Hunger

  6 months

Study Arms (2)

Mindfulness Orientated Recovery Enhancement (MORE) Intervention

EXPERIMENTAL

8-week MORE intervention adapted for preventing weight regain

Behavioral: Mindfulness Orientated Recovery Enhancement

Control Intervention

ACTIVE COMPARATOR

8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program.

Behavioral: Control Intervention

Interventions

Mindfulness Orientated Recovery Enhancement BEHAVIORAL

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.

Also known as: MORE

Mindfulness Orientated Recovery Enhancement (MORE) Intervention

Control Intervention BEHAVIORAL

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.

Control Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Weight Loss; Weight Gain; Feeding Behavior; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Limitations and Caveats

This was a pilot and feasibility trial with a relatively small and non-diverse sample. We included patients who had experienced weight loss via diet/exercise, medication, and bariatric surgery. Due to the quasi-experimental design, we were not able to randomize based on weight loss modality which resulted in a severely skewed sample with most patients who reported to be on weight loss medications to be allocated to the BWI comparison group.

Results Point of Contact

• Title: Tanya Halliday, PhD, RD
• Organization: University of Utah

tanya.halliday@utah.edu

801-213-1364

Study Officials

• Tanya Halliday

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: June 16, 2021
• Primary Completion: May 8, 2023
• Study Completion: May 22, 2024
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)