Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics

This study is ongoing, but not recruiting participants.
Palo Alto Medical Foundation
Information provided by (Responsible Party):
Gladys Block, Berkeley Analytics, Inc. Identifier:
First received: November 22, 2011
Last updated: February 5, 2015
Last verified: February 2015
The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.

Condition Intervention
Behavioral: Alive-PD
Behavioral: Usual Care

Study Type: Interventional
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, 6 months and one year ] [ Designated as safety issue: No ]
    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

  • Change from baseline in diabetes risk markers [ Time Frame: at 3 months, 6 months and one year ] [ Designated as safety issue: No ]
    Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months

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

Estimated Enrollment: 268
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: participation in Alive-PD
Alive-PD lifestyle intervention with multi-channel delivery
Behavioral: Alive-PD
Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
Placebo Comparator: Control
Usual care
Behavioral: Usual Care
Placebo Control


Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01479062

United States, California
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301
Sponsors and Collaborators
Berkeley Analytics, Inc.
Palo Alto Medical Foundation
Principal Investigator: Gladys Block, PhD Berkeley Analytics, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gladys Block, Principal Investigator, Berkeley Analytics, Inc. Identifier: NCT01479062     History of Changes
Other Study ID Numbers: 1R44NR012617-01 
Study First Received: November 22, 2011
Last Updated: February 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Berkeley Analytics, Inc.:
behavior change
diabetes prevention
Hemoglobin A1c
physical activity

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on April 27, 2016