Call-2-Health: Preventing Type II Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2

• Registration Number: NCT01827826
• Lead Sponsor: Kaiser Permanente

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-10
• Study Completion: 2012-06
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Telephonic intervention to prevent Diabetes Mellitus, Type 2	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.

Primary Outcome Measures

Name	Time	Method
Program feasibility: Uptake	Baseline	Measured by the number of people who consent to be in the study compared to the number who were eligible
Program feasibility: Attendance	52 weeks	Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)

Secondary Outcome Measures

Name	Time	Method
Fasting glucose	Baseline, 12 weeks, 24 weeks, 52 weeks	Measured via a fasting blood draw
Waist circumference	Baseline, 12 weeks, 24 weeks	in centimeters
Blood pressure	Baseline, 12 weeks, 24 weeks	Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
Healthy eating habits	Baseline, 12 weeks, 24 weeks	Assessed using the Food Frequency Questionnaire
Weight loss	Baseline, 12 weeks, 24 weeks, 52 weeks	Weight measured in kilograms
Changes in activity	Baseline, 12 weeks, 24 weeks, 52 weeks	Measured using the Modifiable Activity Questionnaire (MAQ)
Glycated hemoglobin (A1C)	Baseline, 12 weeks, 24 weeks, 52 weeks	Measured via a fasting blood draw
Total cholesterol (TC)	Baseline, 12 weeks, 24 weeks, 52 weeks	Measured via a fasting blood draw
High density lipoprotein (HDL)	Baseline, 12 weeks, 24 weeks, 52 weeks	Measured via a fasting blood draw
Low density lipoprotein (LDL)	Baseline, 12 weeks, 24 weeks, 52 weeks	Measured via fasting blood draw.
Body Mass Index (BMI)	Baseline, 12 weeks, 24 weeks, 52 weeks
Physical activity level	Baseline, 12 weeks, 24 weeks, 52 weeks	Participants wore a blinded pedometer for 3 days

Trial Locations

Locations (1)

Group Health Research Institute; 🇺🇸 Seattle, Washington, United States