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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephonic intervention to prevent Diabetes Mellitus, Type 2
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Intervention, Telephone, Diabetes, Prevention

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2012
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT01827826
Brief Title
Call-2-Health: Preventing Type II Diabetes
Acronym
C2H
Official Title
Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Intervention, Telephone, Diabetes, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Telephonic intervention to prevent Diabetes Mellitus, Type 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Program feasibility: Uptake
Description
Measured by the number of people who consent to be in the study compared to the number who were eligible
Time Frame
Baseline
Title
Program feasibility: Attendance
Description
Measured by the number of participants who return for their 12 week clinic visit
Time Frame
12 weeks
Title
Program feasibility: Attendance
Description
Measured by the number of participants who return for their 24 week clinic visit
Time Frame
24 weeks
Title
Program feasibility: Attendance
Description
Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Fasting glucose
Description
Measured via a fasting blood draw
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks
Title
Waist circumference
Description
in centimeters
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Blood pressure
Description
Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Healthy eating habits
Description
Assessed using the Food Frequency Questionnaire
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Weight loss
Description
Weight measured in kilograms
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks
Title
Changes in activity
Description
Measured using the Modifiable Activity Questionnaire (MAQ)
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks
Title
Glycated hemoglobin (A1C)
Description
Measured via a fasting blood draw
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks
Title
Total cholesterol (TC)
Description
Measured via a fasting blood draw
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks
Title
High density lipoprotein (HDL)
Description
Measured via a fasting blood draw
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks
Title
Low density lipoprotein (LDL)
Description
Measured via fasting blood draw.
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks
Title
Body Mass Index (BMI)
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks
Title
Physical activity level
Description
Participants wore a blinded pedometer for 3 days
Time Frame
Baseline, 12 weeks, 24 weeks, 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Newton, PhD
Organizational Affiliation
Group Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

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Call-2-Health: Preventing Type II Diabetes

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