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

January 16, 2018 updated by: Gladys Block, Berkeley Analytics, Inc.

Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

339

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Usual care
Behavioral: Usual Care
Placebo Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 3 months, 6 months and one year
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
at 3 months, 6 months and one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berkeley Analytics, Inc.

Collaborators

Palo Alto Medical Foundation

Investigators

  • Principal Investigator: Gladys Block, PhD, Berkeley Analytics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 24, 2011

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R44NR012617-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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