Childhood ObesityNCT01156402
Childhood Obesity Prevention Program for Hispanics
A study testing Healthy Families-Childhood Obesity Prevention and Oral Health in people with Childhood Obesity, run by Meharry Medical College at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood obesity intervention with Hispanic families. The program aims at preventing childhood obesity by targeting parents to address nutrition, physical activity, and sedentary behaviors in their children. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Healthy Families-Childhood Obesity Prevention and Oral Health
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to May 2016
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- 5-7 year-old female or male of Hispanic origin (identified by parent)
- resident of Davidson County or adjacent counties
- ≥25th percentile of age- and sex-specific BMI (CDC growth charts) or one parent/caregiver with BMI ≥ 25 kg/m2
- More than one child may enroll per family
- Parents:
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- Hispanic origin (self-identified)
- Spanish speaker
- adult age 18 or older
- parent of at least one eligible child
- Only one parent per family may enroll as a study participant and respond to questionnaires
Who cannot join
- Children:
- BMI ≥ 35 kg/m2
- Medical conditions affecting growth
- Conditions limiting participation in the interventions or measurements
- Taking medications affecting growth
- No consent or inability to understand informed consent
Show all 10Show fewer
- Incomplete or missed baseline assessments
- Plan to move from geographic area within the next 12 months.
- Parents:
- No exclusions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University
Nashville, Tennessee, 37203
Meharry Medical College
Nashville, Tennessee, 37208
About this study
Official title: Culturally-Appropriate Childhood Obesity Prevention Program for Hispanic Families
The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood obesity intervention with Hispanic families. The program aims at preventing childhood obesity by targeting parents to address nutrition, physical activity, and sedentary behaviors in their children.
Read the detailed description
Childhood obesity has been ranked as a critical public health threat in the U.S. due to the increasing prevalence of obesity among children over the past three decades. Childhood obesity poses both intermediate and long-term health risks, as well as considerable economic costs. While this epidemic affects all socioeconomic levels, certain racial/ethnic groups are disproportionately affected, including Hispanics.The long-term goal of the current research is to contribute to the reduction of racial/ethnic disparities in obesity and obesity-related outcomes among Hispanics by testing a childhood obesity prevention program that has been culturally tailored for the Hispanic population through a participatory process. This developmental community-based participatory research (CBPR) project is a collaborative community-academic partnership between Meharry Medical College (MMC), Tennessee State University-Center for Health Research (TSU-CHR), and a grassroots community-based organization called Progreso Community Center (PCC). The Childhood Obesity Study is designed to evaluate two programs for Hispanic children ages 5 to 7 and their parents. One program focuses on nutrition and physical activity (based on NIH's "We Can!" program), and a parallel program focuses on oral health (developed by TSU's Dental Hygiene Program). Upon enrollment in the Study, parents and children will respond to an initial interview involving body measurement and questionnaire. Families will be given physical activity monitor to be worn for 7 days and randomly assigned to one of two groups. The families assigned to the Nutrition and Physical Activity Program will attend eight (8) bi-weekly classes (one every two weeks for four months) dealing with nutrition and physical activity. In the Oral Health Program families will attend 4 monthly classes (once a month for four months). These sessions deal with ways to take care of children's teeth and oral health. In addition, these families will have the opportunity to sign up for a free dental cleaning and assessment at the Dental Hygiene Clinic at Tennessee State University.
- Conditions
- Childhood Obesity
- Being tested
- Healthy Families-Childhood Obesity Prevention and Oral Health
- Keywords
- Obesity, Pediatric Obesity
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Families-Childhood Obesity Prevention and Oral HealthBehavioural
The active intervention was adapted from the We Can! parent intervention to be culturally-appropriate for Hispanic families of children ages 5-7. The tailored intervention is based on Social Cognitive Theory and Behavioral Choice Theory to provide parents and children with cognitive and behavioral skills to enable change in the target behaviors, and to encourage them to practice using these skills to strengthen their perceived competence in using these behaviors effectively.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention: Obesity Prevention | Experimental | Not described Receives: Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health |
| Alternative Intervention/control: Oral Health | Experimental | Not described Receives: Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)-for-age percentile
Measured: one year
Secondary outcomes (4)
Child eating behaviors
Measured: One year
Child physical activity (accelerometers)
Measured: One year
Parenting strategies
Measured: One year
parent physical activity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2013
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156402
- Sponsor's protocol ID
- 030425PC062 03 (Meharry IRB)
- Status last verified
- May 2016
- First submitted
- 14 Jun 2010
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zoorob R, Buchowski MS, Beech BM, Canedo JR, Chandrasekhar R, Akohoue S, Hull PC. Healthy families study: design of a childhood obesity prevention trial for Hispanic families. Contemp Clin Trials. 2013 Jul;35(2):108-21. doi: 10.1016/j.cct.2013.04.005. Epub 2013 Apr 26.
PubMed 23624172
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-Appropriate Childhood Obesity Prevention Program for Hispanic Families
- ClinicalTrials.gov ID
- NCT01156402
- Acronym / sponsor ID
- 030425PC062 03 (Meharry IRB)
- Conditions
- Childhood Obesity
- Keywords
- Obesity, Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- May 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Jul 2010 (estimated)
- 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 purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood obesity intervention with Hispanic families. The program aims at preventing childhood obesity by targeting parents to address nutrition, physical activity, and sedentary behaviors in their children.
Detailed description
Childhood obesity has been ranked as a critical public health threat in the U.S. due to the increasing prevalence of obesity among children over the past three decades. Childhood obesity poses both intermediate and long-term health risks, as well as considerable economic costs. While this epidemic affects all socioeconomic levels, certain racial/ethnic groups are disproportionately affected, including Hispanics.The long-term goal of the current research is to contribute to the reduction of racial/ethnic disparities in obesity and obesity-related outcomes among Hispanics by testing a childhood obesity prevention program that has been culturally tailored for the Hispanic population through a participatory process. This developmental community-based participatory research (CBPR) project is a collaborative community-academic partnership between Meharry Medical College (MMC), Tennessee State University-Center for Health Research (TSU-CHR), and a grassroots community-based organization called Progreso Community Center (PCC). The Childhood Obesity Study is designed to evaluate two programs for Hispanic children ages 5 to 7 and their parents. One program focuses on nutrition and physical activity (based on NIH's "We Can!" program), and a parallel program focuses on oral health (developed by TSU's Dental Hygiene Program). Upon enrollment in the Study, parents and children will respond to an initial interview involving body measurement and questionnaire. Families will be given physical activity monitor to be worn for 7 days and randomly assigned to one of two groups. The families assigned to the Nutrition and Physical Activity Program will attend eight (8) bi-weekly classes (one every two weeks for four months) dealing with nutrition and physical activity. In the Oral Health Program families will attend 4 monthly classes (once a month for four months). These sessions deal with ways to take care of children's teeth and oral health. In addition, these families will have the opportunity to sign up for a free dental cleaning and assessment at the Dental Hygiene Clinic at Tennessee State University.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Intervention: Obesity Prevention | Experimental | Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health |
| Alternative Intervention/control: Oral Health | Experimental | Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 5-7 year-old female or male of Hispanic origin (identified by parent)
- resident of Davidson County or adjacent counties
- ≥25th percentile of age- and sex-specific BMI (CDC growth charts) or one parent/caregiver with BMI ≥ 25 kg/m2
- More than one child may enroll per family
- Hispanic origin (self-identified)
Key exclusion criteria (10 listed)
- BMI ≥ 35 kg/m2
- Medical conditions affecting growth
- Conditions limiting participation in the interventions or measurements
- Taking medications affecting growth
- No consent or inability to understand informed consent
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 |
|---|---|---|
| Healthy Families-Childhood Obesity Prevention and Oral HealthThe active intervention was adapted from the We Can! parent intervention to be culturally-appropriate for Hispanic families of children ages 5-7. The tailored intervention is based on Social Cognitive Theory and Behavioral Choice Theory to provide parents and children with cognitive and behavioral skills to enable change in the target behaviors, and to encourage them to practice using these skills to strengthen their perceived competence in using these behaviors effectively. | Behavioural | Active Intervention: Obesity Prevention, Alternative Intervention/control: Oral Health |
Primary outcome
Body Mass Index (BMI)-for-age percentile
Time frame: one year
4 secondary outcomes
Child eating behaviors
Time frame: One year
Child physical activity (accelerometers)
Time frame: One year
Parenting strategies
Time frame: One year
parent physical activity
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Background: PubMed 23624172Zoorob R, Buchowski MS, Beech BM, Canedo JR, Chandrasekhar R, Akohoue S, Hull PC. Healthy families study: design of a childhood obesity prevention trial for Hispanic families. Contemp Clin Trials. 2013 Jul;35(2):108-21. doi: 10.1016/j.cct.2013.04.005. Epub 2013 Apr 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Families-Childhood Obesity Prevention and Oral Health in people with Childhood Obesity, run by Meharry Medical College at 2 sites 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Mass Index (BMI)-for-age percentile (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01156402, which also lists 1 linked publication.
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 6 May 2016; AzTrials last refreshed its copy on 1 Nov 2026.