Call-2-Health: Preventing Type II Diabetes

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention, Telephone, Diabetes, Prevention