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BOUNCE to Health: A Healthy Lifestyle Program (BOUNCE)

Primary Purpose

Childhood Obesity, Obesity, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Percent Body Fat
percent body fat obtained from a foot-to-foot bio-electrical impedance assessment
Anthropometric Change in Abdominal Fat
assessed through waist circumference (WC) measurements following guidelines from National Health and Nutrition Examination
Anthropometric Change in Hip Circumference
hip circumference (HC) measurements following guidelines from National Health and Nutrition Examination (for parents only)

Secondary Outcome Measures

Physical Activity
Motion analyzer measures the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week
Sweetened Drinks
self-report measure
Fried Food Consumption
self-report measure

Full Information

First Posted
April 8, 2019
Last Updated
April 29, 2019
Sponsor
University of Houston
Collaborators
United Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03925012
Brief Title
BOUNCE to Health: A Healthy Lifestyle Program
Acronym
BOUNCE
Official Title
BOUNCE to Health: A Healthy Lifestyle Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
United Health Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Obesity, Physical Activity, Health Knowledge, Attitudes, Practice, Health Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Primary Outcome Measure Information:
Title
Change in Percent Body Fat
Description
percent body fat obtained from a foot-to-foot bio-electrical impedance assessment
Time Frame
pre & post intervention at Week 4
Title
Anthropometric Change in Abdominal Fat
Description
assessed through waist circumference (WC) measurements following guidelines from National Health and Nutrition Examination
Time Frame
pre & post intervention at Week 4
Title
Anthropometric Change in Hip Circumference
Description
hip circumference (HC) measurements following guidelines from National Health and Nutrition Examination (for parents only)
Time Frame
pre & post intervention at Week 4
Secondary Outcome Measure Information:
Title
Physical Activity
Description
Motion analyzer measures the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week
Time Frame
pre & post intervention at Week 4
Title
Sweetened Drinks
Description
self-report measure
Time Frame
pre & post intervention at Week 4
Title
Fried Food Consumption
Description
self-report measure
Time Frame
pre & post intervention at Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma Olvera, PhD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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BOUNCE to Health: A Healthy Lifestyle Program

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