Diabetes Prevention Program Pilot Study - Full Text View

Purpose

This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. NIH is asking for health care centers to show ways to provide this treatment at a reasonable cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention in a primary care health care setting (University of Rochester Primary Care).

Condition	Intervention
Diabetes Prevention	Behavioral: DPP


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study

Further study details as provided by Geoffrey Williams, University of Rochester:

Primary Outcome Measures:

The primary outcome measure is weight loss with a goal of 7% of initial weight. [ Time Frame: 6 months ]

Secondary Outcome Measures:

Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week [ Time Frame: 6 months ]
;Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day;Fasting blood sugar < 100 mg/dL; Absence of tobacco use [ Time Frame: 6 months ]


Enrollment:	36
Study Start Date:	December 2008
Study Completion Date:	October 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Subject will be randomly assigned to work with providers at Clinton Medical Associates	Behavioral: DPP The primary outcome measure is weight loss with a goal of 7% of initial weight. Secondary outcomes are adherence to behavior changes: Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day Fasting blood sugar < 100 mg/dL Absence of tobacco use
Active Comparator: 2 Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125	Behavioral: DPP The primary outcome measure is weight loss with a goal of 7% of initial weight. Secondary outcomes are adherence to behavior changes: Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day Fasting blood sugar < 100 mg/dL Absence of tobacco use

Arms

Assigned Interventions

Active Comparator: 1

Subject will be randomly assigned to work with providers at Clinton Medical Associates

Behavioral: DPP

The primary outcome measure is weight loss with a goal of 7% of initial weight.
Secondary outcomes are adherence to behavior changes:
1. Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
2. Fat intake less than 25% and saturated fat less than 10%
3. Fiber intake of at least 25 grams per day
4. Fasting blood sugar < 100 mg/dL
5. Absence of tobacco use

Active Comparator: 2

Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125

Behavioral: DPP

The primary outcome measure is weight loss with a goal of 7% of initial weight.
Secondary outcomes are adherence to behavior changes:
1. Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
2. Fat intake less than 25% and saturated fat less than 10%
3. Fiber intake of at least 25 grams per day
4. Fasting blood sugar < 100 mg/dL
5. Absence of tobacco use

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age >18 years
BMI >24 kg/m2 (>22 kg/m2 among Asian Americans)
IGT (2-h plasma glucose 140~199 mg/dl based on 75-g OGTT if available). The OGTT will not be required for inclusion, but the CMA practitioners may wish to recommend the OGTT for their patients.
Elevated FPG (95~125 mg/dl*).
HDL-triglyceride ration > 3.5.

Exclusion Criteria:

Diabetes at baseline
FPG >126 mg/dl*
2-h plasma glucose >200 mg/dl based on 75-g OGTT, if available. OGTT will not be required (see above note).
Diabetes diagnosed by a physician and confirmed by other clinical data, other than during pregnancy.
Ever used antidiabetic medication, other than during pregnancy
Medical conditions likely to limit life span and/or increase risk of intervention
Cardiovascular disease
Hospitalization for treatment of heart disease in past 6 months New York Heart Association Functional Class> 2
Left bundle branch block or third degree AV block Aortic stenosis
Systolic blood pressure> 180 mmHg or diastolic blood pressure> 105 mmHg
Cancer requiring treatment in the past 5 years, unless the prognosis is considered good
Renal disease (creatinine GFR < or = 30 ml/hr or > 2.0 mg/dl if GFR not available).
Anemia (hematocrit <36% in men or <33% in women)
Hepatitis (based on history or serum transaminase elevation)
Other gastrointestinal disease (pancreatitis, acute inflammatory bowel disease)
Recent or significant abdominal surgery
Pulmonary disease with dependence on oxygen or daily use of bronchodilators
Chronic infection (e.g., HIV, active tuberculosis)
Conditions or behaviors likely to affect conduct of the trial
Unable to communicate with clinic staff (e.g., read and speak English).
Unwilling to accept treatment assignment by randomization
Participation in another intervention research project that might interfere with DPP
Weight loss of > 10% in past 6 months for any reason except postpartum weight loss
Unable to walk 0.25 miles in 10 min
Currently pregnant or within 3 months postpartum
Currently nursing or within 6 weeks of having completed nursing
Pregnancy anticipated during the course of the trial
Unwilling to undergo pregnancy testing or report possible pregnancy promptly
Unwilling to take adequate contraceptive measures, if potentially fertile
Major psychiatric disorder, including severe active major depression, severe anxiety, schizophrenia, manic depression, bi-polar disorder
Excessive alcohol intake, either acute or chronic
Medications and medical conditions likely to confound the assessment for diabetes including:
- Niacin, in doses indicated for lowering serum triglycerides
- Glucocorticoids, systemic
Other prescription weight-loss medications
Active Thyroid disease, suboptimally treated as indicated by abnormal serum thyroid-stimulating hormone
Other endocrine disorders (e.g., Cushing's syndrome, acromegaly)
Fasting plasma triglyceride >600 mg/dl, despite treatment

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729079

Locations


United States, New York
Clinton Medical Associated
Rochester, New York, United States, 14620
Therapeutic Lifestyle Changes
Rochester, New York, United States, 14620

Sponsors and Collaborators

University of Rochester

Investigators


Principal Investigator:	Geoffrey C Williams, MD, PhD	University ofRochester
Principal Investigator:	Heather Patrick, PhD	University of Rochester

More Information

Additional Information:

Diabetes Prevention Program This link exits the ClinicalTrials.gov site

Publications:

American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012.

Benjamin SM, Valdez R, Geiss LS, Rolka DB, Narayan KM. Estimated number of adults with prediabetes in the US in 2000: opportunities for prevention. Diabetes Care. 2003 Mar;26(3):645-9.

Goldstein MG, Whitlock EP, DePue J; Planning Committee of the Addressing Multiple Behavioral Risk Factors in Primary Care Project. Multiple behavioral risk factor interventions in primary care. Summary of research evidence. Am J Prev Med. 2004 Aug;27(2 Suppl):61-79. Review.

Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, Hamman RF, Ackermann RT, Engelgau MM, Ratner RE; Diabetes Prevention Program Research Group. The cost-effectiveness of lifestyle modification or metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med. 2005 Mar 1;142(5):323-32.

Maciosek MV, Edwards NM, Coffield AB, Flottemesch TJ, Nelson WW, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: methods. Am J Prev Med. 2006 Jul;31(1):90-6. Review.

Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50.

Westfall JM, Mold J, Fagnan L. Practice-based research--"Blue Highways" on the NIH roadmap. JAMA. 2007 Jan 24;297(4):403-6.

Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26.


Responsible Party:	Geoffrey Williams, Professor, University of Rochester
ClinicalTrials.gov Identifier:	NCT00729079 History of Changes
Other Study ID Numbers:	24895
First Submitted:	August 1, 2008
First Posted:	August 6, 2008
Last Update Posted:	October 12, 2015
Last Verified:	March 2013

Keywords provided by Geoffrey Williams, University of Rochester:


Diabetes Prevention Pre-Diabetes Exercise	Fat Intake Fasting blood sugar tobacco cessation

Additional relevant MeSH terms:


Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

Diabetes Prevention Program Pilot Study (DPP)