Taking Action Together- A Diabetes Prevention Program

Type 2 Diabetes Clinical Trial

— TAT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039116
• Other study ID #: USDA 2004-35215-14250
• Status: Completed
• Phase: N/A
• First received: December 23, 2009
• Last updated: May 3, 2011
• Start date: March 2005
• Est. completion date: December 2009

Study information

• Verified date: March 2007
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	YMCA of the East Bay, Oakland, CA 94612	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (10)

Fyfe M, Raman A, Sharma S, Hudes ML, Fleming SE. Insulin resistance and self-perceived scholastic competence in inner-city, overweight and obese, African American children. Physiol Behav. 2011 Jan 10;102(1):36-41. doi: 10.1016/j.physbeh.2010.09.015. Epub — View Citation

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. doi: 10.1038/oby.2008.329. — View Citation

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. — View Citation

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 — View Citation

Raman A, Sharma S, Fitch MD, Fleming SE. Anthropometric correlates of lipoprotein profile and blood pressure in high BMI African American children. Acta Paediatr. 2010 Jun;99(6):912-9. doi: 10.1111/j.1651-2227.2009.01639.x. Epub 2010 Jan 7. — View Citation

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. doi: 10.1186/1745-6 — View Citation

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 Apr 15. — View Citation

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. doi: 10.1186/1743-7075-6-41. — View Citation

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. doi: 10.1186/1743-7075-7-10. — View Citation

Susan Stone,Aarthi Raman, Sharon Fleming.Behavioral characteristics among obese/overweight inner-city African American Children: A secondary analysis of participants in a community-based Type 2 diabetes risk reduction program. Children and Youth Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 Year change in insulin resistance via HOMA-IR	Baseline HOMA-IR minus Year 1 HOMA-IR	Change during first year	No
Primary	2 year change in insulin resistance via HOMA-IR	Baseline HOMA-IR minus Year 2 HOMA-IR	Change during 2 years	No
Secondary	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.		3years	No

External Links

•   Taking Action Together: Overview and Curriculum