Back to resultsEating Mindfully to Prevent Weight Regain (EMPWR)
Primary Purpose
Weight Loss, Weight Gain, Eating Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Orientated Recovery Enhancement
Control Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Weight Loss focused on measuring Appetite Regulation, Weight regain prevention, Weight loss maintenance, mindfulness, mindfulness orientated recovery enhancement
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.
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Orientated Recovery Enhancement (MORE) Intervention
Control Intervention
Arm Description
8-week MORE intervention adapted for preventing weight regain
8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program.
Outcomes
Primary Outcome Measures
Changes in Body Weight
Measured via calibrated digital scale
Changes in Body Composition
Measured via BodPod
Secondary Outcome Measures
Changes in Food-Related Behaviors
Evaluated via brief the Ways of Savoring Questionnaire
Changes in Ad libitum Energy Intake - Free Living
3 days of free-living ad libitum energy intake (via self-report)
Changes in Food-Related Behaviors
Evaluated via Three-Factor Eating Questionnaire
Changes in Food-Related Behaviors
Evaluated via the Weight Efficacy Lifestyle Questionnaire
Changes in Food-Related Behaviors
Evaluated via the Food Craving Inventory
Changes in Food-Related Behaviors
Evaluated via the Multidimensional Assessment of Interoceptive Awareness
Change in Ad libitum Energy Intake - In lab
In lab ad libitum buffet lunch (via weigh and measure methodology)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04847843
Brief Title
Eating Mindfully to Prevent Weight Regain
Acronym
EMPWR
Official Title
Targeting Maladaptive Eating Behaviors With Mindfulness-based Training to Prevent Weight Regain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Weight Gain, Eating Behavior, Obesity, Bariatric Surgery Candidate
Keywords
Appetite Regulation, Weight regain prevention, Weight loss maintenance, mindfulness, mindfulness orientated recovery enhancement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Orientated Recovery Enhancement (MORE) Intervention
Arm Type
Experimental
Arm Description
8-week MORE intervention adapted for preventing weight regain
Arm Title
Control Intervention
Arm Type
Active Comparator
Arm Description
8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Orientated Recovery Enhancement
Other Intervention Name(s)
MORE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Body Weight
Description
Measured via calibrated digital scale
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
Title
Changes in Body Composition
Description
Measured via BodPod
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
Secondary Outcome Measure Information:
Title
Changes in Food-Related Behaviors
Description
Evaluated via brief the Ways of Savoring Questionnaire
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
Title
Changes in Ad libitum Energy Intake - Free Living
Description
3 days of free-living ad libitum energy intake (via self-report)
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
Title
Changes in Food-Related Behaviors
Description
Evaluated via Three-Factor Eating Questionnaire
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
Title
Changes in Food-Related Behaviors
Description
Evaluated via the Weight Efficacy Lifestyle Questionnaire
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
Title
Changes in Food-Related Behaviors
Description
Evaluated via the Food Craving Inventory
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
Title
Changes in Food-Related Behaviors
Description
Evaluated via the Multidimensional Assessment of Interoceptive Awareness
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
Title
Change in Ad libitum Energy Intake - In lab
Description
In lab ad libitum buffet lunch (via weigh and measure methodology)
Time Frame
Measured at baseline, post intervention(Week 8), and 6 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Miranda
Phone
8012131364
Email
tori.miranda@utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Halliday
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Miranda
Email
EMPWR@utah.edu
12. IPD Sharing Statement
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Eating Mindfully to Prevent Weight Regain
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