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

Primary Purpose

Obesity, Overweight, Excessive Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
after school ethnic dance program - ballet folklorica
culturally-tailored, home-based screen time reduction
culturally-tailored health and nutrition education
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring obesity, prevention, girls, Latina/Hispanic, Dance, television, screen time

Eligibility Criteria

7 Years - 9 Years (Child)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford Prevention Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

After school ethnic dance and home-based screen time reduction

Health and Nutrition Education

Arm Description

After school ethnic dance classes and home-based screen time reduction intervention

Health and nutrition education active placebo control intervention

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)

Secondary Outcome Measures

waist circumference
triceps skinfold thickness
systolic and diastolic resting blood pressures
resting heart rate
screen time
meals eaten with television
average dietary energy intake and percent of energy from fat
average daily total physical activity and moderate-to-vigorous physical activity
weight concerns

Full Information

First Posted
May 18, 2007
Last Updated
December 12, 2012
Sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00476775
Brief Title
Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls
Acronym
ECHALE
Official Title
Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Excessive Weight Gain
Keywords
obesity, prevention, girls, Latina/Hispanic, Dance, television, screen time

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
After school ethnic dance and home-based screen time reduction
Arm Type
Experimental
Arm Description
After school ethnic dance classes and home-based screen time reduction intervention
Arm Title
Health and Nutrition Education
Arm Type
Active Comparator
Arm Description
Health and nutrition education active placebo control intervention
Intervention Type
Behavioral
Intervention Name(s)
after school ethnic dance program - ballet folklorica
Intervention Type
Behavioral
Intervention Name(s)
culturally-tailored, home-based screen time reduction
Intervention Type
Behavioral
Intervention Name(s)
culturally-tailored health and nutrition education
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Time Frame
change over 2 years
Secondary Outcome Measure Information:
Title
waist circumference
Time Frame
over 2 years
Title
triceps skinfold thickness
Time Frame
over 2 years
Title
systolic and diastolic resting blood pressures
Time Frame
over 2 years
Title
resting heart rate
Time Frame
over 2 years
Title
screen time
Time Frame
over 2 years
Title
meals eaten with television
Time Frame
over 2 years
Title
average dietary energy intake and percent of energy from fat
Time Frame
over 2 years
Title
average daily total physical activity and moderate-to-vigorous physical activity
Time Frame
over 2 years
Title
weight concerns
Time Frame
over 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas N Robinson, M.D., M.P.H.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Prevention Research Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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