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OpenTrials
Completed

NCT Number: NCT01039116

Taking Action Together- A Diabetes Prevention Program

The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.

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Key information

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YMCA of the East Bay, Oakland, CA 94612

Oakland, California, 94612, United States

About this study

In the United States and, indeed, worldwide the prevalence of overweight and obesity has increased at an unprecedented rate. Concomitant with this demographic change are increases in diseases including type 2 diabetes, cardiovascular disease and some cancers that are associated with body fatness. Strategies to reduce body weight have been largely unsuccessful, making it unlikely that our population will be made healthy simply by recommending that overweight people reduce their body fatness. There is evidence, however, that the impact of body fat on human health can be significantly attenuated by potentially achievable strategies. Such strategies require adequate intakes of essential nutrients, regular physical activity and strong self-esteem. The goal of the project is to reduce the risk of type 2 diabetes mellitus (T2DM) in overweight 9- to 10-year-old African American children through a multi-component community-based program. The specific objectives are to (1).Implement a randomly controlled 2-phase intervention involving a 2-week summer camp, and weekly & monthly reinforcement sessions over 2 years, that include nutrition education, physical activity promotion, and self-esteem and self-efficacy building and (2) Test effectiveness of the program after 1 and 2 years of intervention on insulin sensitivity, the primary outcome, and on secondary outcomes including body fatness, dietary intakes, physical activity, and self-esteem. Identifying an effective, community-based program that could reduce risk of type 2 diabetes in high-risk children would promote health, reduce disease and reduce health-care costs in the future.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child age of 9-10 yr old at baseline
  • Child BMI at least 85th percentile when matched for age and gender
  • Able and willing to participate in normal daily activities
  • Living in inner-city regions of Oakland CA

Exclusion criteria

  • Fasting blood glucose of 120 mg/dl or higher
  • Diagnosis of diabetes or other central metabolic disease
  • Taking medications that interfere with or treat main study outcomes

Treatment and study plan

High Intensity

Behavioral

High-intensity intervention, Experimental. Participating children were invited to attend a 2 week summer day camp at the beginning of each intervention year, and to attend a weekly, 2 hr interactive session for children. Activities provided hand-on experiences preparing and tasting healthy food alternatives, engaging in a range of physical activities and self-esteem boosting via activities that promoted communication and positive behavioral development.

Low Intensity

Behavioral

Low-intensity intervention, Active comparator. Participants were provided with educational materials 4 times yearly.

Primary outcomes

  1. 1 Year change in insulin resistance via HOMA-IR

    Time frame: Change during first year

    Baseline HOMA-IR minus Year 1 HOMA-IR

  2. 2 year change in insulin resistance via HOMA-IR

    Time frame: Change during 2 years

    Baseline HOMA-IR minus Year 2 HOMA-IR

Secondary outcomes

  1. Change in dietary intakes of energy, fat, carbohydrate and selected essential nutrients. Change in minutes/day spend in moderate- and high-intensity physical activity. Improvement or stabilization of self-esteem.

    Time frame: 3years

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Taking Action Together: Development, Implementation and Evaluation of Community-Based Programs That Aims to Reduce Risk of Type 2 Diabetes in High BMI African American Children.

Acronym: TAT

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Dec 24, 2009
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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