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

NCT00123032 | Withdrawn DMC

• 1 other identifier: 228
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiovascular Diseases; Heart Diseases; Obesity

Outcome Measures

Primary Outcomes (2)

• BMI of children

  Fall 2005 through Summer 2008

• Percentage of body fat of children (measured at the end of the 1st grade school year)

  Baseline and followup

Secondary Outcomes (6)

• Total daily physical activity level of children

  Daily during intervention period

• Nutrient and food group analysis of school meals and snacks

  Baseline and followup

• Assessment of classroom food and physical activity practices

  Daily during intervention period

• Measures of household food availability

  Baseline and followup

• Parent reports of their eating and physical activity behaviors

  Baseline and followup

Study Arms (2)

1

EXPERIMENTAL

This group will focus on improving their diet and increasing physical activity at home and at school.

Behavioral: Diet; Procedure: Exercise

2

NO INTERVENTION

A control group will not receive any intervention.

Interventions

Diet BEHAVIORAL

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.

1

Exercise PROCEDURE

Increase active recess time, implement classroom action breaks and increase school PE class time to increase physical activity among participants.

1

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

University of Minnesota Twin Cities

Minneapolis, Minnesota, 55454, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• Zhang J, Himes JH, Hannan PJ, Arcan C, Smyth M, Rock BH, Story M. Summer effects on body mass index (BMI) gain and growth patterns of American Indian children from kindergarten to first grade: a prospective study. BMC Public Health. 2011 Dec 23;11:951. doi: 10.1186/1471-2458-11-951.

  PMID: 22192795 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mary Story, MD

  University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2005
• First Posted: July 22, 2005
• Study Start: January 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2011
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

US (2)