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BOUNCE to Health: A Healthy Lifestyle Program (BOUNCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03925012
Recruitment Status : Active, not recruiting
First Posted : April 23, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
United Health Foundation
Information provided by (Responsible Party):
Norma Olvera, University of Houston

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).

Condition or disease Intervention/treatment Phase
Childhood Obesity Obesity Physical Activity Health Knowledge, Attitudes, Practice Health Behavior Behavioral: Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BOUNCE to Health: A Healthy Lifestyle Program
Actual Study Start Date : June 2016
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

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.
Behavioral: Intervention



Primary Outcome Measures :
  1. 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

  2. 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

  3. Anthropometric Change in Hip Circumference [ Time Frame: pre & post intervention at Week 4 ]
    hip circumference (HC) measurements following guidelines from National Health and Nutrition Examination (for parents only)


Secondary Outcome Measures :
  1. 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

  2. Sweetened Drinks [ Time Frame: pre & post intervention at Week 4 ]
    self-report measure

  3. Fried Food Consumption [ Time Frame: pre & post intervention at Week 4 ]
    self-report measure



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925012


Locations
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United States, Texas
University of Houston
Houston, Texas, United States, 77204
Sponsors and Collaborators
University of Houston
United Health Foundation
Investigators
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Principal Investigator: Norma Olvera, PhD University of Houston

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Responsible Party: Norma Olvera, Principal Investigator, University of Houston
ClinicalTrials.gov Identifier: NCT03925012     History of Changes
Other Study ID Numbers: 16447-01
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms