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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-11

Study Completion Date

2021-03-30

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.

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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.

Conditions

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Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Lifestyle Program ONLY

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

Group Type ACTIVE_COMPARATOR

Traditional Healthy Lifestyle Program

Intervention Type BEHAVIORAL

Twice weekly meetings that focus on nutrition and exercise for 12 weeks.

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.

Group Type EXPERIMENTAL

Traditional Healthy Lifestyle Program

Intervention Type BEHAVIORAL

Twice weekly meetings that focus on nutrition and exercise for 12 weeks.

Mindfulness Meditation Instruction

Intervention Type BEHAVIORAL

Participants receive six mindfulness sessions.

Interventions

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Traditional Healthy Lifestyle Program

Twice weekly meetings that focus on nutrition and exercise for 12 weeks.

Intervention Type BEHAVIORAL

Mindfulness Meditation Instruction

Participants receive six mindfulness sessions.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No