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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827826
First Posted: April 10, 2013
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kaiser Permanente
  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 (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 Kaiser Permanente:

Primary Outcome Measures:
  • Program feasibility: Uptake [ Time Frame: Baseline ]
    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 ]
    Measured by the number of participants who return for their 12 week clinic visit

  • Program feasibility: Attendance [ Time Frame: 24 weeks ]
    Measured by the number of participants who return for their 24 week clinic visit

  • Program feasibility: Attendance [ Time Frame: 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:
  • Fasting glucose [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
    Measured via a fasting blood draw

  • Waist circumference [ Time Frame: Baseline, 12 weeks, 24 weeks ]
    in centimeters

  • Blood pressure [ Time Frame: Baseline, 12 weeks, 24 weeks ]
    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 ]
    Assessed using the Food Frequency Questionnaire

  • Weight loss [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
    Weight measured in kilograms

  • Changes in activity [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
    Measured using the Modifiable Activity Questionnaire (MAQ)

  • Glycated hemoglobin (A1C) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
    Measured via a fasting blood draw

  • Total cholesterol (TC) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
    Measured via a fasting blood draw

  • High density lipoprotein (HDL) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
    Measured via a fasting blood draw

  • Low density lipoprotein (LDL) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
    Measured via fasting blood draw.

  • Body Mass Index (BMI) [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
  • Physical activity level [ Time Frame: Baseline, 12 weeks, 24 weeks, 52 weeks ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827826


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

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01827826     History of Changes
Other Study ID Numbers: 184802-16
First Submitted: September 11, 2012
First Posted: April 10, 2013
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
Intervention
Telephone
Diabetes
Prevention

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