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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: Traditional Healthy Lifestyle Program; Behavioral: Mindfulness Meditation Instruction

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06520
      • Yale Center for Clinical Investigation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional Lifestyle Program ONLY; Participants will receive an evidence-based 12-week family-based pediatric obesity program.	Behavioral: Traditional Healthy Lifestyle Program; Twice weekly meetings that focus on nutrition and exercise for 12 weeks.
EXPERIMENTAL: Traditional Lifestyle Program PLUS Mindfulness; Participants will receive an evidence-based 12-week family-based pediatric obesity program plus 6 sessions of mindfulness meditation instruction.	Behavioral: Traditional Healthy Lifestyle Program; Twice weekly meetings that focus on nutrition and exercise for 12 weeks.; Behavioral: Mindfulness Meditation Instruction; Participants receive six mindfulness sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	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	Change from baseline at 12 weeks
Body Mass Index (BMI)	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	Change from baseline at 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Body Fat	Tanita Body Fat Analyzer uses a foot-to-foot bioelectrical impedence to capture participant's percent body fat.	Change from baseline at 12 weeks
Percent Body Fat	Tanita Body Fat Analyzer uses a foot-to-foot bioelectrical impedence to capture participant's percent body fat.	Change from baseline at 9 months
Perceived Stress Scale	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.	Change from baseline at 12 weeks
Perceived Stress Scale	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.	Change from baseline at 9 months
Physical Stress	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.	Change from baseline at 12 weeks
Physical Stress	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.	Change from baseline at 9 months
Caloric Intake	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.	Change from baseline at 12 weeks
Fat Intake	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.	Change from baseline at 12 weeks
Sugar Intake	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.	Change from baseline at 12 weeks
Caloric Intake	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.	Change from baseline at 9 months
Fat Intake	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.	Change from baseline at 9 months
Sugar Intake	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.	Change from baseline at 9 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Friends of Yale New Haven Children's Hospital

Publications and helpful links

Helpful Links

• weight management program website

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 11, 2018
• Primary Completion (ACTUAL): March 30, 2021
• Study Completion (ACTUAL): March 30, 2021

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (ACTUAL): August 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pediatric obesity, stress
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Obesity; Pediatric Obesity; Body Weight
• Other Study ID Numbers: 2000021532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No