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NCT00061165 · ClinicalTrials.gov registry record · NA

Obesity Prevention in African American School Children

A NA study of Obesity, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
NA
Development phase
900
Enrollment target
1
Study location

NCT00061165 is a NA study of Obesity that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 900 participants, above the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (10% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00061165, a NA study of Obesity, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
NA
Development phase
900 participants
Enrollment target
1
Study location

Study Summary

Obesity is the second leading preventable cause of disease and death in the United States. Low socioeconomic status (SES) and minorities are disproportionately affected. Obesity prevention among children and adolescents is a public health priority. Schools have been identified as key settings for obesity prevention; however, most health education interventions have had only a moderate effect on body weight. We propose a randomized intervention trial (pilot study) to test the feasibility and effectiveness of a school-based, environmental obesity prevention program in urban low-SES African American students. Schools, students and their families, and local communities will be involved to promote healthy eating and physical activity (HEPA) for prevention of childhood obesity. Six Chicago public schools will be randomly assigned as intervention (4 schools) and controls (2 schools). Focus group studies will assess needs and barriers for promotion of HEPA and guide the intervention. The intervention group will receive a School Environment Enrichment (SEE) program to modify the school physical and social environment, targeting food service, recess, physical education (PE) and school climate, and a Community Support \& Environment Modification (CSEM) program, involving local corner and chain grocery stores to promote healthy eating among students and their families. Family involvement will be included for 5th and 6th graders, who will be followed for two years, to test ways to modify family environment. To assess the intervention effectiveness, multilevel data will be collected from schools (eg, food service, recess and PE), students (eg, body weight, eating and physical activity), parents (eg, family food purchasing practices) and communities (eg, available choices of snack foods in local stores). In addition, process evaluation data will be collected to assess the feasibility and acceptance (participation and satisfaction) of various intervention components by the target a

Conditions Studied

Interventions

  • BEHAVIORAL School + family changes promoting healthy eating + activity

Study Locations (1)

Illinois

  • University of Illinois at Chicago, Department of Human Nutrition - Chicago

Trial Details

FieldValue
Enrollment Target 900 participants
Start Date 2003-02
Phase NA

What the Registry Record Tells You About NCT00061165

The ClinicalTrials.gov registry entry for NCT00061165 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (10% higher). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which School + family changes promoting healthy eating + activity is the first listed.

NCT00061165 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT00061165 about?

NCT00061165 is a clinical study titled "Obesity Prevention in African American School Children". Obesity is the second leading preventable cause of disease and death in the United States. Low socioeconomic status (SES) and minorities are disproportionately affected. Obesity prevention among children and adolescents is a public health priority. Schools have been identified as key settings for ob...

What is the current status of trial NCT00061165?

This trial is currently completed. It is a NA study. The enrollment target is 900 participants. The study started on 2003-02.

What conditions does trial NCT00061165 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT00061165?

The interventions under investigation include: School + family changes promoting healthy eating + activity (BEHAVIORAL).

Who is sponsoring clinical trial NCT00061165?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00061165 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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