Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2010-07-31
2012-06-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
74 Years
ALL
Yes
Sponsors
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Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Katherine Newton, PhD
Role: PRINCIPAL_INVESTIGATOR
Group Health Research Institute
Locations
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Group Health Research Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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184802-16
Identifier Type: -
Identifier Source: org_study_id