Clinical trial NCT04847843: Eating Mindfully to Prevent Weight Regain
Official title: Targeting Maladaptive Eating Behaviors With Mindfulness-based Training to Prevent Weight Regain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Weight Gain
Eating Behavior
Obesity
Bariatric Surgery Candidate
Keywords: Appetite Regulation
Weight regain prevention
Weight loss maintenance
mindfulness
mindfulness orientated recovery enhancement
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Changes in Body Weight
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
measure: Changes in Body Composition
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Secondary outcomes:
measure: Changes in Food-Related Behaviors
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
measure: Changes in Ad libitum Energy Intake - Free Living
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
measure: Changes in Food-Related Behaviors
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
measure: Changes in Food-Related Behaviors
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
measure: Changes in Food-Related Behaviors
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
measure: Changes in Food-Related Behaviors
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
measure: Change in Ad libitum Energy Intake - In lab
timeFrame: Measured at baseline, post intervention(Week 8), and 6 month follow up
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Tanya Halliday
role: PRINCIPAL_INVESTIGATOR
References: