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

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ClinicalTrials.gov Identifier: NCT01479062
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Palo Alto Medical Foundation
Information provided by (Responsible Party):
Gladys Block, Berkeley Analytics, Inc.

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

Condition or disease Intervention/treatment Phase
Pre-diabetes Diabetes Obesity Behavioral: Alive-PD Behavioral: Usual Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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



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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Publications of Results:
Other Publications:
Responsible Party: Gladys Block, Principal Investigator, Berkeley Analytics, Inc.
ClinicalTrials.gov Identifier: NCT01479062     History of Changes
Other Study ID Numbers: 1R44NR012617-01 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: July 2016

Keywords provided by Gladys Block, Berkeley Analytics, Inc.:
behavior change
pre-diabetes
prevention
diabetes prevention
Hemoglobin A1c
glucose
physical activity
nutrition
email
web
obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia