Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Palo Alto Medical Foundation
Information provided by (Responsible Party):
Gladys Block, Berkeley Analytics, Inc.
ClinicalTrials.gov Identifier:
NCT01479062
First received: November 22, 2011
Last updated: February 5, 2015
Last verified: February 2015
History of Changes
  Purpose

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
Pre-diabetes
Diabetes
Obesity
 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:

U.S. FDA Resources

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479062

Locations
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
Investigators
Principal Investigator: Gladys Block, PhD Berkeley Analytics, Inc.
  More Information

Publications:

Responsible Party: Gladys Block, Principal Investigator, Berkeley Analytics, Inc.
ClinicalTrials.gov 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
pre-diabetes
prevention
diabetes prevention
Hemoglobin A1c
glucose
 physical activity
nutrition
email
web
obesity

ClinicalTrials.gov processed this record on March 03, 2015