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

Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Group Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; 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.	Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2; Participants assigned to the intervention group received a total of 16 phone calls from the study interventionist over 24 weeks. The first 12 weeks was the intervention phase and calls were made weekly. The second 12 weeks was the maintenance phase and calls were made every 3 weeks. After 24 weeks, the investigators continued to follow this group for 52 weeks post-randomization, allowing half of the group to continue to receive monthly maintenance calls while the other half received no further calls. The study interventionist used behavior modification techniques to encourage intervention group participants to adopt healthy eating and exercise habits so that improvement might be seen in fasting glucose, glycated hemoglobin (HbA1c), weight, and waist/hip measurements.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program feasibility: Uptake	Measured by the number of people who consent to be in the study compared to the number who were eligible	Baseline
Program feasibility: Attendance	Measured by the number of participants who return for their 12 week clinic visit	12 weeks
Program feasibility: Attendance	Measured by the number of participants who return for their 24 week clinic visit	24 weeks
Program feasibility: Attendance	Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)	52 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Katherine Newton, PhD, Group Health Research Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 11, 2012
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 10, 2013

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; Prevention; Intervention; Telephone
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 184802-16