Pediatric Obesity
Conditions
Keywords
pediatric obesity, stress
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.
Interventions
BEHAVIORALTraditional Healthy Lifestyle Program
Twice weekly meetings that focus on nutrition and exercise for 12 weeks.
BEHAVIORALMindfulness Meditation Instruction
Participants receive six mindfulness sessions.
Sponsors
Friends of Yale New Haven Children's Hospital
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale | 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. |
| Physical Stress | 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. |
| Percent Body Fat | Change from baseline at 12 weeks | Tanita Body Fat Analyzer uses a foot-to-foot bioelectrical impedence to capture participant's percent body fat. |
| Fat Intake | 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. |
| Sugar Intake | 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. |
| Caloric Intake | 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. |
Countries
United States
Outcome results
None listed