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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

BOUNCE to Health: A Healthy Lifestyle Program

Clinicaltrials.gov identifier NCT03925012

Recruitment Status Active, not recruiting

First Posted April 23, 2019

Last update posted May 1, 2019

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).

  • Condition or Disease:Childhood Obesity
    Obesity
    Physical Activity
    Health Knowledge, Attitudes, Practice
    Health Behavior
  • Intervention/Treatment: Behavioral: Intervention
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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
Arms and interventions
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
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 9 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 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.

Contacts and Locations
Contacts
Locations

United States, Texas
University of Houston
Houston

Sponsors and Collaborators

University of Houston

United Health Foundation

Investigators

Principal Investigator: Norma Olvera, PhD University of Houston

More Information
  • Responsible Party: 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Obesity Pediatric Obesity