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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03925012
Other study ID # 16447-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2022

Study information

Verified date April 2019
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the BOUNCE study is to assess the effectiveness of a four-week family-based healthy lifestyle summer program in reducing adiposity indicators in Hispanic and African American girls and boys (ages 9-14 years old).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 720
Est. completion date December 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 9 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention


Locations

Country Name City State
United States University of Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Houston United Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Percent Body Fat percent body fat obtained from a foot-to-foot bio-electrical impedance assessment pre & post intervention at Week 4
Primary Anthropometric Change in Abdominal Fat assessed through waist circumference (WC) measurements following guidelines from National Health and Nutrition Examination pre & post intervention at Week 4
Primary Anthropometric Change in Hip Circumference hip circumference (HC) measurements following guidelines from National Health and Nutrition Examination (for parents only) pre & post intervention at Week 4
Secondary Physical Activity 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
Secondary Sweetened Drinks self-report measure pre & post intervention at Week 4
Secondary Fried Food Consumption self-report measure pre & post intervention at Week 4
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