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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01827826
First received: September 11, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Program feasibility: Uptake [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measured by the number of people who consent to be in the study compared to the number who were eligible

  • Program feasibility: Attendance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured by the number of participants who return for their 12 week clinic visit

  • Program feasibility: Attendance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Measured by the number of participants who return for their 24 week clinic visit

  • Program feasibility: Attendance [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Measured via a fasting blood draw

  • Waist circumference [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    in centimeters

  • Blood pressure [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)

  • Healthy eating habits [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Assessed using the Food Frequency Questionnaire

  • Weight loss [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Weight measured in kilograms

  • Changes in activity [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Measured using the Modifiable Activity Questionnaire (MAQ)

  • Glycated hemoglobin (A1C) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Measured via a fasting blood draw

  • Total cholesterol (TC) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Measured via a fasting blood draw

  • High density lipoprotein (HDL) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Measured via a fasting blood draw

  • Low density lipoprotein (LDL) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Measured via fasting blood draw.

  • Body Mass Index (BMI) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Physical activity level [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Participants wore a blinded pedometer for 3 days


Enrollment: 47
Study Start Date: July 2010
Study Completion Date: June 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827826

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Katherine Newton, PhD Group Health Research Institute
  More Information

No publications provided

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT01827826     History of Changes
Other Study ID Numbers: 184802-16
Study First Received: September 11, 2012
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Intervention
Telephone
Diabetes
Prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014