School- and Home-Based Program to Prevent Obesity in American Indian Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00123032
First received: July 20, 2005
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to prevent excessive weight gain among kindergarten and first grade American Indian children using improved diet and increased physical activity at home and at school.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Obesity
Behavioral: Diet
Procedure: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bright Start: Obesity Prevention in American Indian Children

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • BMI of children [ Time Frame: Fall 2005 through Summer 2008 ] [ Designated as safety issue: No ]
  • Percentage of body fat of children (measured at the end of the 1st grade school year) [ Time Frame: Baseline and followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total daily physical activity level of children [ Time Frame: Daily during intervention period ] [ Designated as safety issue: No ]
  • Nutrient and food group analysis of school meals and snacks [ Time Frame: Baseline and followup ] [ Designated as safety issue: No ]
  • Assessment of classroom food and physical activity practices [ Time Frame: Daily during intervention period ] [ Designated as safety issue: No ]
  • Measures of household food availability [ Time Frame: Baseline and followup ] [ Designated as safety issue: No ]
  • Parent reports of their eating and physical activity behaviors [ Time Frame: Baseline and followup ] [ Designated as safety issue: No ]
  • Parent reports of their children's eating and physical activity behaviors (measured at the end of the 1st grade school year) [ Time Frame: Baseline and followup ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2005
Estimated Study Completion Date: December 2011
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This group will focus on improving their diet and increasing physical activity at home and at school.
Behavioral: Diet
Increase the availability of fruits and vegetables, serve recommended portion sizes and reduce availability of excessive energy-dense foods at school cafeterias to improve the diet of participants at school breakfast, lunch and snacks.
Procedure: Exercise
Increase active recess time, implement classroom action breaks and increase school PE class time to increase physical activity among participants.
No Intervention: 2
A control group will not receive any intervention.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in kindergarten at one of the participating elementary schools on the Pine Ridge or Rosebud reservations in South Dakota

Exclusion Criteria:

  • Schools who do not meet the criteria stated above and are not willing to sign the memorandum of agreement outlining expectations of the school and the University of Minnesota.
  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: NCT00123032

Locations
United States, Minnesota
University of Minnesota Twin Cities
Minneapolis, Minnesota, United States, 55454
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
Investigators
Study Chair: Mary Story, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcy Story, University of Minnesota
ClinicalTrials.gov Identifier: NCT00123032     History of Changes
Other Study ID Numbers: 228, R01 HL78846
Study First Received: July 20, 2005
Last Updated: April 18, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014