ObesityECHALENCT00476775
Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls
A study testing after school ethnic dance program - ballet folklorica, culturally-tailored, home-based screen time reduction and culturally-tailored health and nutrition education in people with Obesity and Overweight, run by Stanford University at 1 site in United States.
Trial summary
A randomized controlled trial to test the efficacy of an after school ethnic dance program plus a culturally-tailored, home-based screen time reduction intervention to reduce weight gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls. Read more about this study
- Who is it for?
- Ages 7 to 9 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Excessive Weight Gain
- What is being tested?
- after school ethnic dance program - ballet folklorica, culturally-tailored, home-based screen time reduction and culturally-tailored health and nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2012
- 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 7 to 9 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Defined as Latina or Hispanic by parent/guardian.
- Attends one of the participating public elementary schools.
Who cannot join
- Diagnosed with a medical condition affecting growth.
- Taking medications affecting growth.
- A condition limiting participation in the interventions.
- A condition limiting participation in the assessments.
- Plan to move from the area within the next 24 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Prevention Research Center
Stanford, California, 94305
About this study
A randomized controlled trial to test the efficacy of an after school ethnic dance program plus a culturally-tailored, home-based screen time reduction intervention to reduce weight gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls.
Read the detailed description
We propose a 2-arm, parallel group, randomized controlled trial to test the efficacy of an after school ethnic dance program plus a culturally-tailored, home-based screen time reduction intervention to reduce weight gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls. The control group will receive an "active-placebo" information-based health education intervention. A total of 240 7-9 year old girls will be randomized to the two conditions, and both interventions will last for the full 2-year period of the study for each girl.
Latina girls are at increased risk of obesity and obesity-related morbidities. However, effective and generalizable obesity prevention programs for this rapidly growing population are not available. After school ethnic dance programs are highly motivating, and an innovative approach to providing a large "dose" of moderate-to-vigorous physical activity for Latina girls. After school programs may also indirectly reduce sedentary behavior and improve diet. Dance is fun for pre-adolescent girls, it plays an important social and cultural role in Latino communities, and after school dance classes are a potentially generalizable "environmental" intervention strategy. Our past pilot studies and ongoing trials of ethnic dance interventions demonstrate that (1) dance is a highly attractive and feasible form of activity for pre-adolescent girls and (2) a dance intervention can result in reduced weight gain (BMI) and increased fitness among girls.
Latina girls are also heavy consumers of screen-based media, television, videotapes/DVDs and video games. Excessive screen time is considered one of the most modifiable causes of childhood obesity. We propose a culturally-tailored, home-based screen time reduction intervention, delivered by bilingual, Latina, Community Health Advisors (CHAs). Our prior and ongoing studies demonstrate the feasibility and potential efficacy of (1) reducing children's screen time to reduce weight gain and (2) providing home-based behavior change interventions to low-income Latino families using CHAs. All interventions will be further developed, revised, and pilot-tested with Latina girls and their families through formative research.
240 girls Latina girls will be recruited over 18 months from six public elementary schools serving low-income Latino communities in northern CA. Measures will be collected in girls' homes at baseline, 6, 12, 18 and 24 months, including height and weight, waist circumference, triceps skinfold thickness, blood pressure and resting heart rate, physical activity monitoring by accelerometry, media use, 24-hour dietary recalls, weight concerns, depressive symptoms, school performance, sexual maturation, and demographics. Body Mass Index (BMI) is the primary outcome measure. The primary outcome analysis will compare individual trajectories of change in BMI in the treatment and control groups over the entire two-year course of the trial, using random regression models. The study is powered (90%) to detect a clinically-significant effect. Specific Aims include:
- To test the efficacy of a combined, after school ethnic dance and home-based screen time reduction intervention to reduce weight gain (BMI) over 2 years. Primary hypothesis: Compared to controls, girls in the treatment group will significantly reduce their weight gain (BMI) over the two-year study period.
- To test the effects of a combined, after school ethnic dance and home-based screen time reduction intervention on secondary outcomes over two years. Secondary hypotheses: Compared to controls, girls in the treatment group will significantly reduce their waist circumference, triceps skinfold thickness, systolic and diastolic resting blood pressures, resting heart rate, television, videotape/DVD and video game use, meals eaten with TV, daily dietary energy intake, percent of energy from fat, weight concerns and depressive symptoms, and significantly increase their daily physical activity, daily moderate to vigorous physical activity, liking for physical activity, and school performance.
- To evaluate potential demographic, cultural, psychological, and biological moderators and mediators of intervention effects on BMI and secondary outcomes, to evaluate correlates and risk factors for change in BMI and secondary outcomes, and to evaluate intervention delivery variables and their relationships to outcomes.
- Conditions
- Obesity, Overweight, Excessive Weight Gain
- Being tested
- after school ethnic dance program - ballet folklorica, culturally-tailored, home-based screen time reduction, culturally-tailored health and nutrition education
- Keywords
- obesity, prevention, girls, Latina/Hispanic, Dance, television, screen time
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
after school ethnic dance program - ballet folkloricaBehavioural
culturally-tailored, home-based screen time reductionBehavioural
culturally-tailored health and nutrition educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| After school ethnic dance and home-based screen time reduction | Experimental | After school ethnic dance classes and home-based screen time reduction intervention Receives: Behavioral: after school ethnic dance program - ballet folklorica; Behavioral: culturally-tailored, home-based screen time reduction |
| Health and Nutrition Education | Active comparator | Health and nutrition education active placebo control intervention Receives: Behavioral: culturally-tailored health and nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Measured: change over 2 years
Secondary outcomes (9)
waist circumference
Measured: over 2 years
triceps skinfold thickness
Measured: over 2 years
systolic and diastolic resting blood pressures
Measured: over 2 years
resting heart rate
Measured: over 2 years
screen time
Measured: over 2 years
meals eaten with television
Measured: over 2 years
average dietary energy intake and percent of energy from fat
Measured: over 2 years
average daily total physical activity and moderate-to-vigorous physical activity
Measured: over 2 years
weight concerns
Measured: over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas N Robinson, M.D., M.P.H., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476775
- Sponsor's protocol ID
- R01DK073006
- Other IDs
- SPO 33483, R01DK073006
- Acronym
- ECHALE
- Status last verified
- Dec 2012
- First submitted
- 18 May 2007
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls
- ClinicalTrials.gov ID
- NCT00476775
- Acronym / sponsor ID
- ECHALE / R01DK073006
- Conditions
- Obesity, Overweight, Excessive Weight Gain
- Keywords
- obesity, prevention, girls, Latina/Hispanic, Dance, television, screen time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 May 2007 (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.
A randomized controlled trial to test the efficacy of an after school ethnic dance program plus a culturally-tailored, home-based screen time reduction intervention to reduce weight gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls.
Detailed description
We propose a 2-arm, parallel group, randomized controlled trial to test the efficacy of an after school ethnic dance program plus a culturally-tailored, home-based screen time reduction intervention to reduce weight gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls. The control group will receive an "active-placebo" information-based health education intervention. A total of 240 7-9 year old girls will be randomized to the two conditions, and both interventions will last for the full 2-year period of the study for each girl.
Latina girls are at increased risk of obesity and obesity-related morbidities. However, effective and generalizable obesity prevention programs for this rapidly growing population are not available. After school ethnic dance programs are highly motivating, and an innovative approach to providing a large "dose" of moderate-to-vigorous physical activity for Latina girls. After school programs may also indirectly reduce sedentary behavior and improve diet. Dance is fun for pre-adolescent girls, it plays an important social and cultural role in Latino communities, and after school dance classes are a potentially generalizable "environmental" intervention strategy. Our past pilot studies and ongoing trials of ethnic dance interventions demonstrate that (1) dance is a highly attractive and feasible form of activity for pre-adolescent girls and (2) a dance intervention can result in reduced weight gain (BMI) and increased fitness among girls.
Latina girls are also heavy consumers of screen-based media, television, videotapes/DVDs and video games. Excessive screen time is considered one of the most modifiable causes of childhood obesity. We propose a culturally-tailored, home-based screen time reduction intervention, delivered by bilingual, Latina, Community Health Advisors (CHAs). Our prior and ongoing studies demonstrate the feasibility and potential efficacy of (1) reducing children's screen time to reduce weight gain and (2) providing home-based behavior change interventions to low-income Latino families using CHAs. All interventions will be further developed, revised, and pilot-tested with Latina girls and their families through formative research.
240 girls Latina girls will be recruited over 18 months from six public elementary schools serving low-income Latino communities in northern CA. Measures will be collected in girls' homes at baseline, 6, 12, 18 and 24 months, including height and weight, waist circumference, triceps skinfold thickness, blood pressure and resting heart rate, physical activity monitoring by accelerometry, media use, 24-hour dietary recalls, weight concerns, depressive symptoms, school performance, sexual maturation, and demographics. Body Mass Index (BMI) is the primary outcome measure. The primary outcome analysis will compare individual trajectories of change in BMI in the treatment and control groups over the entire two-year course of the trial, using random regression models. The study is powered (90%) to detect a clinically-significant effect. Specific Aims include:
- To test the efficacy of a combined, after school ethnic dance and home-based screen time reduction intervention to reduce weight gain (BMI) over 2 years. Primary hypothesis: Compared to controls, girls in the treatment group will significantly reduce their weight gain (BMI) over the two-year study period.
- To test the effects of a combined, after school ethnic dance and home-based screen time reduction intervention on secondary outcomes over two years. Secondary hypotheses: Compared to controls, girls in the treatment group will significantly reduce their waist circumference, triceps skinfold thickness, systolic and diastolic resting blood pressures, resting heart rate, television, videotape/DVD and video game use, meals eaten with TV, daily dietary energy intake, percent of energy from fat, weight concerns and depressive symptoms, and significantly increase their daily physical activity, daily moderate to vigorous physical activity, liking for physical activity, and school performance.
- To evaluate potential demographic, cultural, psychological, and biological moderators and mediators of intervention effects on BMI and secondary outcomes, to evaluate correlates and risk factors for change in BMI and secondary outcomes, and to evaluate intervention delivery variables and their relationships to outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After school ethnic dance and home-based screen time reduction | Experimental | Behavioral: after school ethnic dance program - ballet folklorica, Behavioral: culturally-tailored, home-based screen time reductionAfter school ethnic dance classes and home-based screen time reduction intervention |
| Health and Nutrition Education | Active comparator | Behavioral: culturally-tailored health and nutrition educationHealth and nutrition education active placebo control intervention |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Defined as Latina or Hispanic by parent/guardian.
- Attends one of the participating public elementary schools.
Key exclusion criteria (5 listed)
- Diagnosed with a medical condition affecting growth.
- Taking medications affecting growth.
- A condition limiting participation in the interventions.
- A condition limiting participation in the assessments.
- Plan to move from the area within the next 24 months.
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 |
|---|---|---|
| after school ethnic dance program - ballet folklorica | Behavioural | After school ethnic dance and home-based screen time reduction |
| culturally-tailored, home-based screen time reduction | Behavioural | After school ethnic dance and home-based screen time reduction |
| culturally-tailored health and nutrition education | Behavioural | Health and Nutrition Education |
Primary outcome
Body Mass Index (BMI)
Time frame: change over 2 years
9 secondary outcomes
waist circumference
Time frame: over 2 years
triceps skinfold thickness
Time frame: over 2 years
systolic and diastolic resting blood pressures
Time frame: over 2 years
resting heart rate
Time frame: over 2 years
screen time
Time frame: over 2 years
meals eaten with television
Time frame: over 2 years
average dietary energy intake and percent of energy from fat
Time frame: over 2 years
average daily total physical activity and moderate-to-vigorous physical activity
Time frame: over 2 years
weight concerns
Time frame: over 2 years
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 17 Dec 2012.
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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.
Thomas N Robinson, M.D., M.P.H. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing after school ethnic dance program - ballet folklorica, culturally-tailored, home-based screen time reduction and culturally-tailored health and nutrition education in people with Obesity and Overweight, run by Stanford University 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 2 inclusion and 5 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 17 Dec 2012. 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?
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) (time frame: change over 2 years). 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 17 Dec 2012.