NCT00476775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

3.8 years

First QC Date

May 18, 2007

Last Update Submit

December 12, 2012

Conditions

ObesityOverweightExcessive Weight Gain

Keywords

obesitypreventiongirlsLatina/HispanicDancetelevisionscreen time

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)

    change over 2 years

Secondary Outcomes (9)

  • waist circumference

    over 2 years

  • triceps skinfold thickness

    over 2 years

  • systolic and diastolic resting blood pressures

    over 2 years

  • resting heart rate

    over 2 years

  • screen time

    over 2 years

  • +4 more secondary outcomes

Study Arms (2)

After school ethnic dance and home-based screen time reduction

EXPERIMENTAL

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

Behavioral: after school ethnic dance program - ballet folkloricaBehavioral: culturally-tailored, home-based screen time reduction

Health and Nutrition Education

ACTIVE COMPARATOR

Health and nutrition education active placebo control intervention

Behavioral: culturally-tailored health and nutrition education

Interventions

after school ethnic dance program - ballet folkloricaBEHAVIORAL
After school ethnic dance and home-based screen time reduction
culturally-tailored, home-based screen time reductionBEHAVIORAL
After school ethnic dance and home-based screen time reduction
culturally-tailored health and nutrition educationBEHAVIORAL
Health and Nutrition Education

Eligibility Criteria

Age7 Years - 9 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Defined as Latina or Hispanic by parent/guardian.
  • Attends one of the participating public elementary schools.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Prevention Research Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Thomas N Robinson, M.D., M.P.H.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 22, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2011

Study Completion

August 1, 2012

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

US(1)