Taking Action Together- A Diabetes Prevention Program (TAT)

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT01039116
First received: December 23, 2009
Last updated: May 3, 2011
Last verified: March 2007
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: High Intensity
Behavioral: Low Intensity

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official 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.

Resource links provided by NLM:


Further study details as provided by University of California, Berkeley:

Primary Outcome Measures:
  • 1 Year change in insulin resistance via HOMA-IR [ Time Frame: Change during first year ] [ Designated as safety issue: No ]
    Baseline HOMA-IR minus Year 1 HOMA-IR

  • 2 year change in insulin resistance via HOMA-IR [ Time Frame: Change during 2 years ] [ Designated as safety issue: No ]
    Baseline HOMA-IR minus Year 2 HOMA-IR


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: March 2005
Study Completion Date: December 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Level of intervention intensity

High Intensity: Behavioral 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.

Active Comparator: Low-intensity Participants were provided with educational materials 4 times yearly.

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01039116

Locations
United States, California
YMCA of the East Bay, Oakland, CA 94612
Oakland, California, United States, 94612
Sponsors and Collaborators
University of California, Berkeley
University of California, San Francisco
Investigators
Principal Investigator: Sharon E Fleming, PhD University of California, Berkeley
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sharon E Fleming, Principal Investigator, University of California at Berkeley
ClinicalTrials.gov Identifier: NCT01039116     History of Changes
Other Study ID Numbers: USDA 2004-35215-14250
Study First Received: December 23, 2009
Last Updated: May 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Berkeley:
obesity
nutrition
type 2 diabetes
community-based.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014