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

This study is not yet open for participant recruitment.
Verified November 2011 by Berkeley Analytics, Inc.
Sponsor:
Information provided by (Responsible Party):
Gladys Block, Berkeley Analytics, Inc.
ClinicalTrials.gov Identifier:
NCT01479062
First received: November 22, 2011
Last updated: November 23, 2011
Last verified: November 2011
  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
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:


Further study details as provided by Berkeley Analytics, Inc.:

Primary Outcome Measures:
  • Change from baseline in body weight [ Time Frame: at 3 months and one year ] [ Designated as safety issue: No ]
    Mean weight loss and the proportion of subjects who achieve a 5%, 7% and 10% body weight loss at 3 months and maintain at 12 months

  • Change from baseline in diabetes risk markers [ Time Frame: at 3 months and one year ] [ Designated as safety issue: No ]
    Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic


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: January 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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:

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

Contacts
Contact: Barbara Sternfeld, PhD (510) 891-3717 barbara.sternfeld@kp.org
Contact: Gladys Block, PhD (510) 301-2984 gblock@berkeley.edu

Locations
United States, California
Kaiser Permanente Not yet recruiting
Oakland, California, United States, 94612
Sponsors and Collaborators
Berkeley Analytics, Inc.
Investigators
Principal Investigator: Gladys Block, PhD Berkeley Analytics, Inc.
  More Information

No publications provided

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: November 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Berkeley Analytics, Inc.:
behavior change
pre-diabetes
physical activity
nutrition
email
web
obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014