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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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:

  1. 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.
  2. 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.
  3. 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.
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 groups in NCT00476775
Study groupRoleWhat they receive
After school ethnic dance and home-based screen time reductionExperimentalAfter 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 EducationActive comparatorHealth 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.

  1. Body Mass Index (BMI)

    Measured: change over 2 years

Secondary outcomes (9)
  1. waist circumference

    Measured: over 2 years

  2. triceps skinfold thickness

    Measured: over 2 years

  3. systolic and diastolic resting blood pressures

    Measured: over 2 years

  4. resting heart rate

    Measured: over 2 years

  5. screen time

    Measured: over 2 years

  6. meals eaten with television

    Measured: over 2 years

  7. average dietary energy intake and percent of energy from fat

    Measured: over 2 years

  8. average daily total physical activity and moderate-to-vigorous physical activity

    Measured: over 2 years

  9. 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.

  1. First posted22 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionMar 2011
  4. Study completionAug 2012

Resources

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)
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

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.

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