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

Yale University

Status: Completed

Conditions: Pediatric Obesity

Treatments: Behavioral: Mindfulness Meditation Instruction; Behavioral: Traditional Healthy Lifestyle Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03611660

2000021532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Traditional Lifestyle Program ONLY

Active Comparator group

Description:

Participants will receive an evidence-based 12-week family-based pediatric obesity program.

Treatment:

Behavioral: Traditional Healthy Lifestyle Program

Traditional Lifestyle Program PLUS Mindfulness

Experimental group

Description:

Participants will receive an evidence-based 12-week family-based pediatric obesity program plus 6 sessions of mindfulness meditation instruction.

Treatment:

Behavioral: Mindfulness Meditation Instruction

Behavioral: Traditional Healthy Lifestyle Program