Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476775
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2007-05-18
Brief Title:
Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHALE
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 videotapesDVDs 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 childrens 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 videotapeDVD 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
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 videotapesDVDs 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 childrens 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 videotapeDVD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK073006 | NIH | Stanford University | httpsreporternihgovquickSearchR01DK073006 |
| SPO 33483 | OTHER | None | None |