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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00476775
First received: May 18, 2007
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Obesity
Overweight
Excessive Weight Gain
Behavioral: after school ethnic dance program - ballet folklorica
Behavioral: culturally-tailored, home-based screen time reduction
Behavioral: culturally-tailored health and nutrition education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: change over 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • waist circumference [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • triceps skinfold thickness [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • systolic and diastolic resting blood pressures [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • resting heart rate [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • screen time [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • meals eaten with television [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • average dietary energy intake and percent of energy from fat [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • average daily total physical activity and moderate-to-vigorous physical activity [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • weight concerns [ Time Frame: over 2 years ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: May 2007
Study Completion Date: August 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: After school ethnic dance and home-based screen time reduction
After school ethnic dance classes and home-based screen time reduction intervention
Behavioral: after school ethnic dance program - ballet folklorica Behavioral: culturally-tailored, home-based screen time reduction
Active Comparator: Health and Nutrition Education
Health and nutrition education active placebo control intervention
Behavioral: culturally-tailored health and nutrition education

  Hide Detailed Description

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

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476775

Locations
United States, California
Stanford Prevention Research Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Thomas N Robinson, M.D., M.P.H. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00476775     History of Changes
Other Study ID Numbers: R01 DK073006, SPO 33483, R01DK073006
Study First Received: May 18, 2007
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
obesity
prevention
girls
Latina/Hispanic
Dance
television
screen time

Additional relevant MeSH terms:
Obesity
Weight Gain
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 28, 2014