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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: Traditional Healthy Lifestyle Program
* Behavioral: Mindfulness Meditation Instruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Lifestyle Program ONLY<br>Participants will receive an evidence-based 12-week family-based pediatric obesity program. | Behavioral: Traditional Healthy Lifestyle Program<br>* Twice weekly meetings that focus on nutrition and exercise for 12 weeks.<br>|
| Experimental: Traditional Lifestyle Program PLUS Mindfulness<br>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<br>* Twice weekly meetings that focus on nutrition and exercise for 12 weeks.<br>Behavioral: Mindfulness Meditation Instruction<br>* Participants receive six mindfulness sessions.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric obesity, stress