Eating Mindfully to Prevent Weight Regain (EMPWR)

Utah System of Higher Education (USHE)

Status: Completed

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

Treatments: Behavioral: Control Intervention; Behavioral: Mindfulness Orientated Recovery Enhancement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04847843

0132961

KL2TR002539 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Mindfulness Orientated Recovery Enhancement (MORE) Intervention

Experimental group

Description:

8-week MORE intervention adapted for preventing weight regain

Treatment:

Behavioral: Mindfulness Orientated Recovery Enhancement

Control Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Control Intervention