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

Overview

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

Interventions

  • 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.

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.