EMPWR: Eating Mindfully to Prevent Weight Regain

Sponsor

University of Utah (Other)

Overall Status

Recruiting

CT.gov ID

NCT04847843

Collaborator

(none)

100

Enrollment

Location

Arms

21.5

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Weight Gain Eating Behavior Obesity Bariatric Surgery Candidate	Behavioral: Mindfulness Orientated Recovery Enhancement Behavioral: Control Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 16, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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.

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:

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.