Skip to main content
Clinical Trials/NCT04847843
NCT04847843
Completed
Not Applicable

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

University of Utah1 site in 1 country48 target enrollmentJune 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weight Loss
Sponsor
University of Utah
Enrollment
48
Locations
1
Primary Endpoint
Changes in Body Weight
Status
Completed
Last Updated
5 months ago

Overview

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., 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.

Registry
clinicaltrials.gov
Start Date
June 16, 2021
End Date
May 22, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tanya Halliday

Assistant Professor

University of Utah

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in Body Weight

Time Frame: Baseline and 6 month follow up

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.

Secondary Outcomes

  • Dietary Restraint(6 month follow up)
  • Ways of Savoring Checklist (WOSC).(6-month follow-up)
  • Dietary Disinhibition(6 month follow-up)
  • Interoceptive Awareness(6 month follow up)
  • Hedonic Hunger(6 months)

Study Sites (1)

Loading locations...

Similar Trials