Eating Mindfully to Prevent Weight Regain

Obesity Clinical Trial

— EMPWR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847843
• Other study ID #: 00136609
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: University of Utah
• Contact: Victoria Miranda
• Phone: 8012131364
• Email: tori.miranda[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Body Weight
• Eating Behavior
• Obesity
• Weight Gain
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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