Does Mindfulness Enhance BMI in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?

Not Applicable

Completed

• Conditions: Pediatric Obesity
• Interventions: Behavioral: Traditional Healthy Lifestyle Program; Behavioral: Mindfulness Meditation Instruction

• Registration Number: NCT03611660
• Lead Sponsor: Yale University

Brief Summary

Participants will be randomized to an evidence-based healthy lifestyle program alone or a healthy lifestyle program with mindfulness meditation added. The purpose of the study will be to determine if mindfulness improves BMI outcomes more than the program alone due to the stress-reduction benefits of mindfulness.

Detailed Description

The study will randomize 44 adolescents (aged 11-17 yo) with BMI \>95th percentile to traditional Bright Bodies Healthy Lifestyle Program or Lifestyle Program plus mindfulness meditation (6 sessions within the 12-week program) (22 per group). The traditional program includes exercise two evenings per week and nutrition/behavior modification one evening per week for 12 weeks. Mindfulness session topics include breathing meditation, body scan meditation, mindful eating techniques, and identification of hunger verses satiation. The primary outcome measure with be (1) BMI, while secondary outcomes include changes in (2) percent body fat, (3) perceived stress scale (questionnaire), (4) physical stress (saliva cortisol levels), and (5) overall caloric intake (pre and post food records). After the 3 month intervention, participants will engage in post measures and be asked to return 6 months later (9 months) for longer-term follow-up measures.

Study Timeline

• Study Start: 2018-01-11
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-02
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• BMI >95th percentile for gender & age
• English-speaking subject and parent/caregiver
• Parent/caregiver willing to participate in weight mgt program

Read More

Exclusion Criteria

• BMI >40 <27
• Psychiatric disorder or medical condition that precludes participation in program
• Currently taking medication that causes weight gain or loss
• Involvement in co-existing weight management program
• A positive pregnancy test
• Plans on moving out of the Greater New Haven area within 9 months

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Lifestyle Program PLUS Mindfulness	Mindfulness Meditation Instruction	Participants will receive an evidence-based 12-week family-based pediatric obesity program plus 6 sessions of mindfulness meditation instruction.
Traditional Lifestyle Program PLUS Mindfulness	Traditional Healthy Lifestyle Program	Participants will receive an evidence-based 12-week family-based pediatric obesity program plus 6 sessions of mindfulness meditation instruction.
Traditional Lifestyle Program ONLY	Traditional Healthy Lifestyle Program	Participants will receive an evidence-based 12-week family-based pediatric obesity program.

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	Change from baseline at 9 months	Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703

Secondary Outcome Measures

Name	Time	Method
Physical Stress	Change from baseline at 9 months	A physical indicator of stress is measured by saliva cortisol. We are using saliva swabs by Salimetrics. A normal range for saliva cortisol is 0.007-0.115 mcg/dL. Our hypothesis is a greater change (lowered) in the mindfulness + traditional group than the traditional group alone.
Percent Body Fat	Change from baseline at 9 months	Tanita Body Fat Analyzer uses a foot-to-foot bioelectrical impedence to capture participant's percent body fat.
Caloric Intake	Change from baseline at 9 months	Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.
Sugar Intake	Change from baseline at 9 months	Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.
Perceived Stress Scale	Change from baseline at 9 months	The Perceived Stress Scale is the most widely used psychological instrument for measuring the perception of stress. It is a 10-item likert questionnaire published by Mind Garden that asks about feelings and thoughts during the last month. PSS scores are obtained by reversing responses (i.e., 0=4) for positively stated items and leaving score as is for negatively stated items. An average score for this age group is 14.2, with higher scores indicating more stress. Our hypothesis is a greater change (lower scores at post) in the mindfulness group + traditional than traditional group alone.
Fat Intake	Change from baseline at 9 months	Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.

Trial Locations

Locations (2)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Yale Center for Clinical Investigation; 🇺🇸 New Haven, Connecticut, United States