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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Berkeley Analytics, Inc..
Recruitment status was:  Active, not recruiting
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
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 ]
    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 ]
    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 ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
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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 ( US NIH Grant/Contract Award Number )
Study First Received: November 22, 2011
Last Updated: February 5, 2015

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

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia processed this record on May 23, 2017