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


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

Full Title of Study: “Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2015


  • Behavioral: Alive-PD
    • Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
  • Behavioral: Usual Care
    • Placebo Control

Arms, Groups and Cohorts

  • Experimental: participation in Alive-PD
    • Alive-PD lifestyle intervention with multi-channel delivery
  • Placebo Comparator: Control
    • Usual care

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Berkeley Analytics, Inc.
  • Collaborator
    • Palo Alto Medical Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gladys Block, Principal Investigator – Berkeley Analytics, Inc.
  • Overall Official(s)
    • Gladys Block, PhD, Principal Investigator, Berkeley Analytics, Inc.


Block G, Azar KM, Block TJ, Romanelli RJ, Carpenter H, Hopkins D, Palaniappan L, Block CH. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Jan 21;4(1):e3. doi: 10.2196/resprot.4046.

Citations Reporting on Results

Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.

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