Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Kaiser Permanente
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Program feasibility: Uptake
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translate the findings of the Diabetes Prevention Program into practice. The telephonic intervention will be compared to usual care (30 participants in each group). The investigators will deliver the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24 weeks.
For this planning grant the investigators do not have an overall hypothesis. The investigators' goal is to develop and test whether it is possible to do exercise and weight loss
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female
- •Age 40-74
- •Receives primary care at Group Health Central, Rainier, or Poulsbo clinics in the greater Seattle area
- •Can walk for more than 10 minutes
- •Fasting plasma glucose (FPG) 105-125 mg/dl or glycolated hemoglobin (HbA1C) 5.7-6.4
- •Body Mass Index (BMI) 25 kg/m2 or greater
Exclusion Criteria
- •Type 1 or 2 diabetes
- •FPG \> 125 mg/dl or \< 105mg/dl at screening blood draw
- •HbA1C \> 6.4 or \< 5.7 at screening blood draw
- •Systolic blood pressure \> 210 mmHg at the baseline clinic visit
- •Exercise ≥ 30 minutes/day, at least five days a week
- •Current participation in another structured weight loss treatment program or another intervention study
- •Severe concurrent disease
- •Unavailable for the 24-week study period
- •Unable to read or speak English
- •Pregnant or planning to become pregnant.
Outcomes
Primary Outcomes
Program feasibility: Uptake
Time Frame: Baseline
Measured by the number of people who consent to be in the study compared to the number who were eligible
Program feasibility: Attendance
Time Frame: 52 weeks
Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
Secondary Outcomes
- Fasting glucose(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Waist circumference(Baseline, 12 weeks, 24 weeks)
- Blood pressure(Baseline, 12 weeks, 24 weeks)
- Healthy eating habits(Baseline, 12 weeks, 24 weeks)
- Weight loss(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Changes in activity(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Glycated hemoglobin (A1C)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Total cholesterol (TC)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- High density lipoprotein (HDL)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Low density lipoprotein (LDL)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Body Mass Index (BMI)(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Physical activity level(Baseline, 12 weeks, 24 weeks, 52 weeks)