Call-2-Health: Preventing Type II Diabetes (C2H)

Kaiser Permanente

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01827826

184802-16

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2

Control

No Intervention group

Description:

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.