Clinical trial NCT00476775: Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls
Official title: Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Excessive Weight Gain
Keywords: obesity
prevention
girls
Latina/Hispanic
Dance
television
screen time
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-05-22
Enrollment: 233
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: change over 2 years
Secondary outcomes:
measure: waist circumference
timeFrame: over 2 years
measure: triceps skinfold thickness
timeFrame: over 2 years
measure: systolic and diastolic resting blood pressures
timeFrame: over 2 years
measure: resting heart rate
timeFrame: over 2 years
measure: screen time
timeFrame: over 2 years
measure: meals eaten with television
timeFrame: over 2 years
measure: average dietary energy intake and percent of energy from fat
timeFrame: over 2 years
measure: average daily total physical activity and moderate-to-vigorous physical activity
timeFrame: over 2 years
measure: weight concerns
timeFrame: over 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Prevention Research Center
state: California
Study officials:
affiliation: Stanford University
name: Thomas N Robinson, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: