NCT03925012

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

6.2 years

First QC Date

April 8, 2019

Last Update Submit

April 29, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Percent Body Fat

    percent body fat obtained from a foot-to-foot bio-electrical impedance assessment

    pre & post intervention at Week 4

  • 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

  • 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 Outcomes (3)

  • Physical Activity

    pre & post intervention at Week 4

  • Sweetened Drinks

    pre & post intervention at Week 4

  • Fried Food Consumption

    pre & post intervention at Week 4

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

InterventionBEHAVIORAL
Intervention

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Pediatric ObesityObesityMotor ActivityBehaviorHealth Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Norma Olvera, PhD

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 23, 2019

Study Start

June 1, 2016

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations