NCT01479062
Completed
Not Applicable
Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
Berkeley Analytics, Inc.1 site in 1 country339 target enrollmentFebruary 2014
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-diabetes
- Sponsor
- Berkeley Analytics, Inc.
- Enrollment
- 339
- Locations
- 1
- Primary Endpoint
- Change from baseline in diabetes risk markers
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.
Investigators
Gladys Block
Principal Investigator
Berkeley Analytics, Inc.
Eligibility Criteria
Inclusion Criteria
- •at least one measurement in past 2 yrs of fasting plasma glucose of 100-125 mg/dl or impaired glucose tolerance
- •at least one measurement of body mass index (BMI) \>=27 in the past two years
- •age 40-79
- •no use of diabetes medications within the past two years
- •member of Kaiser Permanente of Northern California (KPNC) for at least 2 years
- •live in a 25 mile radius of the KPNC Research Clinic in Oakland, CA
Exclusion Criteria
- •comorbidities that would contraindicate the gradual adoption of light/moderate physical activity, such as a recent cardiovascular event, severe chronic obstructive pulmonary disease, advanced arthritis, or poorly controlled hypertension
Outcomes
Primary Outcomes
Change from baseline in diabetes risk markers
Time Frame: at 3 months, 6 months and one year
Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months
Change from baseline in body weight
Time Frame: at 3 months, 6 months and one year
Mean weight loss and the proportion of subjects who achieve a 5% body weight loss at 3 and 6 months and maintain at 12 months
Secondary Outcomes
- Change from baseline in physical activity and dietary factors(3 months and 12 months)
Study Sites (1)
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