Eating Mindfully to Prevent Weight Regain

Study 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., 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.

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

Conditions
-----------------
Weight Gain, Weight Loss, Eating Behavior, Obesity, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Orientated Recovery Enhancement
* Behavioral: Control Intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Orientated Recovery Enhancement (MORE) Intervention<br>8-week MORE intervention adapted for preventing weight regain | Behavioral: Mindfulness Orientated Recovery Enhancement<br>* 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.<br>* Other names: MORE;|
| Active Comparator: Control Intervention<br>8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. | Behavioral: Control Intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body Weight | Measured via calibrated digital scale | Measured at baseline, post intervention(Week 8), and 6 month follow up | 
| Changes in Body Composition | Measured via BodPod | Measured at baseline, post intervention(Week 8), and 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Changes in Food-Related Behaviors | Evaluated via Three-Factor Eating Questionnaire | Measured at baseline, post intervention(Week 8), and 6 month follow up | 
| Changes in Food-Related Behaviors | Evaluated via the Weight Efficacy Lifestyle Questionnaire | Measured at baseline, post intervention(Week 8), and 6 month follow up | 
| Changes in Food-Related Behaviors | Evaluated via the Food Craving Inventory | Measured at baseline, post intervention(Week 8), and 6 month follow up | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appetite Regulation, Weight regain prevention, Weight loss maintenance, mindfulness, mindfulness orientated recovery enhancement