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

• ClinicalTrials.gov Identifier: NCT03611660
• Recruitment Status: Completed
• First Posted: August 2, 2018
• Last Update Posted: June 11, 2021
• Sponsor: Yale University
• Collaborator: Friends of Yale New Haven Children's Hospital
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pediatric Obesity	Behavioral: Traditional Healthy Lifestyle Program; Behavioral: Mindfulness Meditation Instruction	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Control Trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Does the Addition of Mindfulness Enhance BMI Outcomes in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
• Actual Study Start Date: January 11, 2018
• Actual Primary Completion Date: March 30, 2021
• Actual Study Completion Date: March 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Traditional Lifestyle Program ONLY; Participants will receive an evidence-based 12-week family-based pediatric obesity program.	Behavioral: Traditional Healthy Lifestyle Program; Twice weekly meetings that focus on nutrition and exercise for 12 weeks.
Experimental: 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.	Behavioral: Traditional Healthy Lifestyle Program; Twice weekly meetings that focus on nutrition and exercise for 12 weeks.; Behavioral: Mindfulness Meditation Instruction; Participants receive six mindfulness sessions.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. Percent Body Fat [ Time Frame: Change from baseline at 12 weeks ]
   Tanita Body Fat Analyzer uses a foot-to-foot bioelectrical impedence to capture participant's percent body fat.
2. Percent Body Fat [ Time Frame: Change from baseline at 9 months ]
   Tanita Body Fat Analyzer uses a foot-to-foot bioelectrical impedence to capture participant's percent body fat.
3. Perceived Stress Scale [ Time Frame: Change from baseline at 12 weeks ]
   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.
4. Perceived Stress Scale [ Time Frame: Change from baseline at 9 months ]
   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.
5. Physical Stress [ Time Frame: Change from baseline at 12 weeks ]
   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.
6. Physical Stress [ Time Frame: Change from baseline at 9 months ]
   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.
7. Caloric Intake [ Time Frame: Change from baseline at 12 weeks ]
   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.
8. Fat Intake [ Time Frame: Change from baseline at 12 weeks ]
   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.
9. Sugar Intake [ Time Frame: Change from baseline at 12 weeks ]
   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.
10. Caloric Intake [ Time Frame: Change from baseline at 9 months ]
    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.
11. Fat Intake [ Time Frame: Change from baseline at 9 months ]
    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.
12. Sugar Intake [ Time Frame: Change from baseline at 9 months ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 11 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Connecticut

Yale Center for Clinical Investigation

New Haven, Connecticut, United States, 06520

Yale University School of Medicine

New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

Friends of Yale New Haven Children's Hospital

More Information

Additional Information:

weight management program website 

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03611660
• Other Study ID Numbers: 2000021532
• First Posted: August 2, 2018
• Last Update Posted: June 11, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:

pediatric obesity, stress

Additional relevant MeSH terms:

Pediatric Obesity; Body Weight; Obesity; Overnutrition; Nutrition Disorders; Overweight