Clinical trial NCT01827826: Call-2-Health: Preventing Type II Diabetes
Official title: Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Intervention
Telephone
Diabetes
Prevention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 47
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: Program feasibility: Uptake
timeFrame: Baseline
measure: Program feasibility: Attendance
timeFrame: 12 weeks
measure: Program feasibility: Attendance
timeFrame: 24 weeks
measure: Program feasibility: Attendance
timeFrame: 52 weeks
Secondary outcomes:
measure: Fasting glucose
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
measure: Waist circumference
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Blood pressure
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Healthy eating habits
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Weight loss
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
measure: Changes in activity
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
measure: Glycated hemoglobin (A1C)
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
measure: Total cholesterol (TC)
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
measure: High density lipoprotein (HDL)
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
measure: Low density lipoprotein (LDL)
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
measure: Body Mass Index (BMI)
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
measure: Physical activity level
timeFrame: Baseline, 12 weeks, 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Group Health Research Institute
name: Katherine Newton, PhD
role: PRINCIPAL_INVESTIGATOR
References: