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Completed

NCT Number: NCT01827826

Call-2-Health: Preventing Type II Diabetes

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group Health Research Institute

Seattle, Washington, 98101, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephonic intervention to prevent Diabetes Mellitus, Type 2

Behavioral

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 outcomes

  1. 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

  2. Program feasibility: Attendance

    Time frame: 12 weeks

    Measured by the number of participants who return for their 12 week clinic visit

  3. Program feasibility: Attendance

    Time frame: 24 weeks

    Measured by the number of participants who return for their 24 week clinic visit

  4. 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 outcomes

  1. Fasting glucose

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Measured via a fasting blood draw

  2. Waist circumference

    Time frame: Baseline, 12 weeks, 24 weeks

    in centimeters

  3. Blood pressure

    Time frame: Baseline, 12 weeks, 24 weeks

    Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)

  4. Healthy eating habits

    Time frame: Baseline, 12 weeks, 24 weeks

    Assessed using the Food Frequency Questionnaire

  5. Weight loss

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Weight measured in kilograms

  6. Changes in activity

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Measured using the Modifiable Activity Questionnaire (MAQ)

  7. Glycated hemoglobin (A1C)

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Measured via a fasting blood draw

  8. Total cholesterol (TC)

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Measured via a fasting blood draw

  9. High density lipoprotein (HDL)

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Measured via a fasting blood draw

  10. Low density lipoprotein (LDL)

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Measured via fasting blood draw.

  11. Body Mass Index (BMI)

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

  12. Physical activity level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Participants wore a blinded pedometer for 3 days

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Acronym: C2H

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 10, 2013
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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