Clinical trial NCT03611660: Does Mindfulness Enhance BMI in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
Official title: Does the Addition of Mindfulness Enhance BMI Outcomes in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: pediatric obesity, stress
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Friends of Yale New Haven Children's Hospital
First posted: 2018-08-02
Enrollment: 42
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Change from baseline at 12 weeks
measure: Body Mass Index (BMI)
timeFrame: Change from baseline at 9 months
Secondary outcomes:
measure: Percent Body Fat
timeFrame: Change from baseline at 12 weeks
measure: Percent Body Fat
timeFrame: Change from baseline at 9 months
measure: Perceived Stress Scale
timeFrame: Change from baseline at 12 weeks
measure: Perceived Stress Scale
timeFrame: Change from baseline at 9 months
measure: Physical Stress
timeFrame: Change from baseline at 12 weeks
measure: Physical Stress
timeFrame: Change from baseline at 9 months
measure: Caloric Intake
timeFrame: Change from baseline at 12 weeks
measure: Fat Intake
timeFrame: Change from baseline at 12 weeks
measure: Sugar Intake
timeFrame: Change from baseline at 12 weeks
measure: Caloric Intake
timeFrame: Change from baseline at 9 months
measure: Fat Intake
timeFrame: Change from baseline at 9 months
measure: Sugar Intake
timeFrame: Change from baseline at 9 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
References: