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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611660
• Other study ID #: 2000021532
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Pediatric Obesity

Intervention

Behavioral:
• Traditional Healthy Lifestyle Program
Twice weekly meetings that focus on nutrition and exercise for 12 weeks.
• Mindfulness Meditation Instruction
Participants receive six mindfulness sessions.

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Friends of Yale New Haven Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   weight management program website