Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls

Obesity Clinical Trial

— ECHALE  

Official title:

Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476775
• Other study ID #: R01DK073006
• Secondary ID: SPO 33483R01DK07
• Status: Completed
• Phase: N/A
• First received: May 18, 2007
• Last updated: December 12, 2012
• Start date: May 2007
• Est. completion date: August 2012

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: August 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 7 Years to 9 Years

Eligibility

Inclusion Criteria:

• Defined as Latina or Hispanic by parent/guardian.

• Attends one of the participating public elementary schools.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Excessive Weight Gain
• Obesity
• Overweight
• Weight Gain

Intervention

Behavioral:
• after school ethnic dance program - ballet folklorica

• culturally-tailored, home-based screen time reduction

• culturally-tailored health and nutrition education

Locations

Country	Name	City	State
United States	Stanford Prevention Research Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)		change over 2 years	No
Secondary	waist circumference		over 2 years	No
Secondary	triceps skinfold thickness		over 2 years	No
Secondary	systolic and diastolic resting blood pressures		over 2 years	No
Secondary	resting heart rate		over 2 years	No
Secondary	screen time		over 2 years	No
Secondary	meals eaten with television		over 2 years	No
Secondary	average dietary energy intake and percent of energy from fat		over 2 years	No
Secondary	average daily total physical activity and moderate-to-vigorous physical activity		over 2 years	No
Secondary	weight concerns		over 2 years	No