Does the Addition of Mindfulness Enhance BMI Outcomes in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Body Mass Index (BMI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Traditional Lifestyle Program ONLY
Participants will receive an evidence-based 12-week family-based pediatric obesity program.
Intervention: Traditional Healthy Lifestyle Program (Behavioral)
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.
Intervention: Traditional Healthy Lifestyle Program (Behavioral)
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.
Intervention: Mindfulness Meditation Instruction (Behavioral)
Outcomes
Primary Outcomes
Body Mass Index (BMI)
Time Frame: 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
Body Mass Index (BMI)
Time Frame: Change from baseline at 12 weeks
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 Outcomes
- Physical Stress(Change from baseline at 9 months)
- Percent Body Fat(Change from baseline at 9 months)
- Caloric Intake(Change from baseline at 9 months)
- Sugar Intake(Change from baseline at 9 months)
- Perceived Stress Scale(Change from baseline at 9 months)
- Fat Intake(Change from baseline at 9 months)
- Percent Body Fat(Change from baseline at 12 weeks)
- Perceived Stress Scale(Change from baseline at 12 weeks)
- Physical Stress(Change from baseline at 12 weeks)
- Caloric Intake(Change from baseline at 12 weeks)
- Fat Intake(Change from baseline at 12 weeks)
- Sugar Intake(Change from baseline at 12 weeks)