MedTrace Logo

Diabetes Prevention Program Pilot Study

NCT00729079 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-10-12

No results posted yet for this study

Summary

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).

Conditions

  • Diabetes Prevention

Interventions

BEHAVIORAL

DPP

1. The primary outcome measure is weight loss with a goal of 7% of initial weight. 2. 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

BEHAVIORAL

DPP

1. The primary outcome measure is weight loss with a goal of 7% of initial weight. 2. 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

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Geoffrey C Williams, MD, PhD · University ofRochester

  • Heather Patrick, PhD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-07-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729079 on ClinicalTrials.gov