Childhood ObesityBOUNCENCT03925012
BOUNCE to Health: A Healthy Lifestyle Program
A study testing Intervention in people with Childhood Obesity and Obesity, run by University of Houston at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Childhood Obesity, Obesity, Physical Activity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Childhood Obesity, Obesity, Physical Activity, Health Knowledge, Attitudes, Practice, Health Behavior
- Being tested
- Intervention
- Medical subject headings
- Pediatric Obesity, Obesity, Motor Activity, Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Body Fat
percent body fat obtained from a foot-to-foot bio-electrical impedance assessment
Measured: 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
Measured: 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)
Measured: pre & post intervention at Week 4
Secondary outcomes (3)
Physical Activity
Motion analyzer measures the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week
Measured: pre & post intervention at Week 4
Sweetened Drinks
self-report measure
Measured: pre & post intervention at Week 4
Fried Food Consumption
self-report measure
Measured: pre & post intervention at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study startJun 2016
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- United Health Foundation
- Responsible party
- Principal investigator, Norma Olvera, University of Houston
- Investigators
- Norma Olvera, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925012
- Sponsor's protocol ID
- 16447-01
- Acronym
- BOUNCE
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOUNCE to Health: A Healthy Lifestyle Program
- ClinicalTrials.gov ID
- NCT03925012
- Acronym / sponsor ID
- BOUNCE / 16447-01
- Conditions
- Childhood Obesity, Obesity, Physical Activity, Health Knowledge, Attitudes, Practice, Health Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- United Health Foundation
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionChild 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. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention | Behavioural | Intervention |
Primary outcome
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
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
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)
3 secondary outcomes
Physical Activity
Time frame: pre & post intervention at Week 4
Sweetened Drinks
Time frame: pre & post intervention at Week 4
Fried Food Consumption
Time frame: pre & post intervention at Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norma Olvera, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Childhood Obesity and Obesity, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Body Fat (time frame: pre & post intervention at Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.