Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics
This study is not yet open for participant recruitment.
Verified November 2011 by Berkeley Analytics, Inc.
Berkeley Analytics, Inc.
Information provided by (Responsible Party):
Gladys Block, Berkeley Analytics, Inc.
First received: November 22, 2011
Last updated: November 23, 2011
Last verified: November 2011
The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)|
Resource links provided by NLM:
Further study details as provided by Berkeley Analytics, Inc.:
Primary Outcome Measures:
- Change from baseline in body weight [ Time Frame: at 3 months and one year ] [ Designated as safety issue: No ]Mean weight loss and the proportion of subjects who achieve a 5%, 7% and 10% body weight loss at 3 months and maintain at 12 months
- Change from baseline in diabetes risk markers [ Time Frame: at 3 months and one year ] [ Designated as safety issue: No ]Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic
Secondary Outcome Measures:
- Change from baseline in physical activity and dietary factors [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: No ]Extent of change in physical activity and dietary factors as reported in questionnaires
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: participation in Alive-PD
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: Control
Behavioral: Usual Care
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479062
|Contact: Barbara Sternfeld, PhD||(510) email@example.com|
|Contact: Gladys Block, PhD||(510) firstname.lastname@example.org|
|United States, California|
|Kaiser Permanente||Not yet recruiting|
|Oakland, California, United States, 94612|
Sponsors and Collaborators
Berkeley Analytics, Inc.
|Principal Investigator:||Gladys Block, PhD||Berkeley Analytics, Inc.|