Call-2-Health: Preventing Type II Diabetes (C2H)
Diabetes Mellitus, Type 2
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Intervention, Telephone, Diabetes, Prevention
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.
- Mentally or legally incapacitated such that informed consent cannot be obtained.
Sites / Locations
- Group Health Research Institute
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Intervention
Control
Participants assigned to the intervention group worked with the study interventionist over the phone to reduce their risk for developing Diabetes Mellitus, Type 2. The intervention lasted for 24 weeks, with weekly phone calls for the first 12 weeks and 4 maintenance calls over the second 12 weeks. Study measurements were taken at baseline, 12 weeks, 24 weeks, and 52 weeks. After 24 weeks, the investigators randomly divided the intervention group in half. The first group did not receive any more phone calls from the interventionist. The second group continued to receive monthly 20-minute phone calls from the interventionist. At 52 weeks post-baseline participants from both groups had their labs drawn, wore a pedometer for 3 days, and called in with a self-reported weight.
Participants randomized into this group did not receive any intervention, although they were encouraged to follow-up with their doctor and follow through with usual clinical care.