- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925012
BOUNCE to Health: A Healthy Lifestyle Program (BOUNCE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The secondary aims of this study are to examine post-intervention changes in eating patterns, body image disturbances, unhealthy weight control practices, and fitness levels.
The investigators hypothesize that at the post-BOUNCE summer intervention, children will exhibit significant decreases in adiposity indicators (percent body fat and waist circumference), sweetened drinks and fried foods consumption, and an increase in physical fitness (aerobic capacity and minutes of moderated-vigorous physical activity) when compared to their baseline values after controlling for demographic, acculturation characteristics.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- University of Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both parental guardians (mother and father) and target child must be of Hispanic or African American descent
- Child must be between the ages of 9-14 years
- Child must be overweight/obese as defined by a body mass index percentile for age- gender specific between the 85th-100th percentile
- Child must have no physical disability or medical conditions that interfere with their participation in an exercise program
- Children must have no extensive diet restrictions that would hinder their participation in the BOUNCE nutrition component (e.g., unable to eat solid foods)
- All children will be required to submit evidence of a medical examination conducted by a health professional
- Parental guardians and child must be available to participate for the duration of the BOUNCE summer
Exclusion Criteria:
- Child and parental guardians are not Hispanic or African American
- Child is not between the ages of 9-14 years
- Child is underweight or normal weight (BMI < 85 percentile) or are morbidly obese (BMI > 100 percentile)
- Child or mother are pregnant or physically unable to participate
- Child has extensive diet restrictions that would hinder their participation in the BOUNCE nutrition component (e.g., unable to eat solid foods)
- Child does not have submitted evidence of a medical examination conducted by a health professional
Note: We will encourage both maternal and paternal guardians to participate in the measurements and interventions. However, if the paternal guardian refuses to participate or there is no father figure present in the family, maternal guardian-child pairs will be still eligible to participate in this study. If the children are of mixed race, but identify themselves as Hispanic or African American and at least one of their parents is either Hispanic or African American, they will be still eligible to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Child participants will attend the healthy lifestyle summer program for 4 weeks, five days per week.
The summer intervention will include daily one-hour nutrition education, one-hour behavioral counseling, and 3 one-hour exercise sessions.
These physical activities include flexibility, games, traditional fitness, and dancing.
Counseling and school psychology students, registered dietitian/nutrition educators, and fitness specialists will lead the respective sessions.
Parental guardians will participate in a two-hour weekly parental sessions that involve: 1)nutrition education with cooking demonstrations of healthy recipes; 2)behavioral counseling to learn effective parenting strategies on how to support their child's healthy nutrition and exercise habits and goals; and 3)exercise sessions where parents will engage in different physical activities and will receive fitness tips on how to promote an active lifestyle for the entire family.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Percent Body Fat
Time Frame: pre & post intervention at Week 4
|
percent body fat obtained from a foot-to-foot bio-electrical impedance assessment
|
pre & post intervention at Week 4
|
Anthropometric Change in Abdominal Fat
Time Frame: pre & post intervention at Week 4
|
assessed through waist circumference (WC) measurements following guidelines from National Health and Nutrition Examination
|
pre & post intervention at Week 4
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Anthropometric Change in Hip Circumference
Time Frame: pre & post intervention at Week 4
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hip circumference (HC) measurements following guidelines from National Health and Nutrition Examination (for parents only)
|
pre & post intervention at Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity
Time Frame: pre & post intervention at Week 4
|
Motion analyzer measures the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week
|
pre & post intervention at Week 4
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Sweetened Drinks
Time Frame: pre & post intervention at Week 4
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self-report measure
|
pre & post intervention at Week 4
|
Fried Food Consumption
Time Frame: pre & post intervention at Week 4
|
self-report measure
|
pre & post intervention at Week 4
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Norma Olvera, PhD, University of Houston
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16447-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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