This trial is active, not recruiting.

Conditions pre-diabetes, diabetes, obesity
Treatments alive-pd, usual care
Sponsor Berkeley Analytics, Inc.
Collaborator Palo Alto Medical Foundation
Start date February 2014
End date October 2015
Trial size 268 participants
Trial identifier NCT01479062, 1R44NR012617-01


The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Alive-PD lifestyle intervention with multi-channel delivery
Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
(Placebo Comparator)
Usual care
usual care
Placebo Control

Primary Outcomes

Change from baseline in body weight
time frame: at 3 months, 6 months and one year
Change from baseline in diabetes risk markers
time frame: at 3 months, 6 months and one year

Secondary Outcomes

Change from baseline in physical activity and dietary factors
time frame: 3 months and 12 months

Eligibility Criteria

Male or female participants from 40 years up to 79 years old.

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

Additional Information

Official title Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
Principal investigator Gladys Block, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Berkeley Analytics, Inc..