Taking Action Together- A Diabetes Prevention Program

NCT01039116 | Completed

• 1 other identifier: USDA 2004-35215-14250
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

obesity; nutrition; type 2 diabetes; community-based.

Outcome Measures

Primary Outcomes (2)

• 1 Year change in insulin resistance via HOMA-IR

  Baseline HOMA-IR minus Year 1 HOMA-IR

  Change during first year

• 2 year change in insulin resistance via HOMA-IR

  Baseline HOMA-IR minus Year 2 HOMA-IR

  Change during 2 years

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.

  3years

Study Arms (1)

Level of intervention intensity

EXPERIMENTAL

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; Behavioral: Low Intensity

Interventions

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.

Level of intervention intensity

Low Intensity BEHAVIORAL

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

Level of intervention intensity

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• University of California, San Francisco: collaborator

Study Sites (1)

YMCA of the East Bay, Oakland, CA 94612

Oakland, California, 94612, United States

Location

Related Publications (11)

• 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.

  PMID: 19186328 RESULT

• 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. doi: 10.1515/jpem.2009.22.7.609.

  PMID: 19774842 RESULT

• 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.

  PMID: 19825190 RESULT

• 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.

  PMID: 20064141 RESULT

• 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 Review 32 (2010)833-839. doi:10.1016/j.childyouth.2010.02.002

  RESULT

• 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.

  PMID: 20181134 RESULT

• 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. doi: 10.1515/jpem.2010.23.1-2.109.

  PMID: 20432814 RESULT

• 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: 10.1186/1745-6215-11-60.

  PMID: 20492667 RESULT

• 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.

  PMID: 21477504 RESULT

• 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 2010 Sep 29.

  PMID: 20887741 RESULT

• 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. doi: 10.1016/j.eatbeh.2012.03.003. Epub 2012 Mar 29.

  PMID: 22664410 DERIVED

Related Links

• Taking Action Together: Overview and Curriculum

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Ultrasonic Waves

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Sharon E Fleming, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: March 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2009
• Last Updated: May 4, 2011

Record last verified: 2007-03

Locations

US (1)