Taking Action Together- A Diabetes Prevention Program - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

U.S. FDA Resources

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.

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

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:

Raman A, Fitch MD, Hudes ML, Lustig RH, Murray CB, Ikeda JP, Fleming SE. Baseline correlates of insulin resistance in inner city high-BMI African-American children. Obesity (Silver Spring). 2008 Sep;16(9):2039-45.

Raman A, Lustig RH, Fitch M, Fleming SE. Accuracy of self-assessed Tanner staging against hormonal assessment of sexual maturation in overweight African-American children. J Pediatr Endocrinol Metab. 2009 Jul;22(7):609-22.

Sharma S, Roberts LS, Hudes ML, Lustig RH, Fleming SE. Macronutrient intakes and cardio metabolic risk factors in high BMI African American children. Nutr Metab (Lond). 2009 Oct 13;6:41.

Raman A, Sharma S, Fitch M, Fleming S. Anthropometric correlates of lipoprotein profile and blood pressure in high BMI African American children. Acta Paediatr. 2010 Jan 7; [Epub ahead of print]

Sharma S, Roberts LS, Lustig RH, Fleming SE. Carbohydrate intake and cardiometabolic risk factors in high BMI African American children. Nutr Metab (Lond). 2010 Feb 9;7(1):10.

Raman A, Ritchie LD, Lustig RH, Fitch MD, Hudes ML, Fleming SE. Insulin resistance is improved in overweight African American boys but not in girls following a one-year multidisciplinary community intervention program. J Pediatr Endocrinol Metab. 2010 Jan-Feb;23(1-2):109-20.

Sharma S, Lustig RH, Fleming SE. Identifying Metabolic Syndrome in African American Children Using Fasting HOMA-IR in Place of Glucose. Prev Chronic Dis. 2011 May;8(3):A64. Epub 2011 Feb 15.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sharma S, Fleming SE. One-year change in energy and macronutrient intakes of overweight and obese inner-city African American children: effect of community-based Taking Action Together type 2 diabetes prevention program. Eat Behav. 2012 Aug;13(3):271-4. Epub 2012 Mar 29.

Ritchie LD, Sharma S, Ikeda JP, Mitchell RA, Raman A, Green BS, Hudes ML, Fleming SE. Taking Action Together: a YMCA-based protocol to prevent type-2 diabetes in high-BMI inner-city African American children. Trials. 2010 May 21;11:60.

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 May 21, 2013

Taking Action Together- A Diabetes Prevention Program (TAT)