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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
47
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.
Group Health Research Institute
Seattle, Washington, United States
Program feasibility: Uptake
Measured by the number of people who consent to be in the study compared to the number who were eligible
Time frame: Baseline
Program feasibility: Attendance
Measured by the number of participants who return for their 12 week clinic visit
Time frame: 12 weeks
Program feasibility: Attendance
Measured by the number of participants who return for their 24 week clinic visit
Time frame: 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)
Time frame: 52 weeks
Fasting glucose
Measured via a fasting blood draw
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Waist circumference
in centimeters
Time frame: Baseline, 12 weeks, 24 weeks
Blood pressure
Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
Time frame: Baseline, 12 weeks, 24 weeks
Healthy eating habits
Assessed using the Food Frequency Questionnaire
Time frame: Baseline, 12 weeks, 24 weeks
Weight loss
Weight measured in kilograms
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Changes in activity
Measured using the Modifiable Activity Questionnaire (MAQ)
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Glycated hemoglobin (A1C)
Measured via a fasting blood draw
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Total cholesterol (TC)
Measured via a fasting blood draw
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
High density lipoprotein (HDL)
Measured via a fasting blood draw
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Low density lipoprotein (LDL)
Measured via fasting blood draw.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Body Mass Index (BMI)
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Physical activity level
Participants wore a blinded pedometer for 3 days
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
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