Diabetes Prevention in Clinical Practice. (DIAVIP)

August 22, 2016 updated by: Göteborg University

Diabetes Prevention in Primary Health Care With Special Emphasis on Physical Activity.

We randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. Continue with your current life style; 2. Ordinary life activities for increased physical activity; 3. Scheduled group activities for changed behavior. The overall aim is to focus on change of physical activity and to keep other life style activities more or less unchanged (diet, smoking, etc) and the effect on metabolic variables.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

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

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Impaired glucose tolerance
  2. Age: 20-85yrs

Exclusion Criteria:

  1. Type2 diabetes
  2. Significant disease making life style changes unlikely to happen
  3. Unable to communicate in Swedish

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
Experimental: Low intensity intervention
Behavioral: Low intensity intervention
We administer, a pedometer and the participants receive a prescription on physical exercise.
Experimental: High intensity intervention
Behavioral: High intensity intervention.
We schedule group sessions for changes in behavior e.g. type of physical activity to prefer, barriers for change of life style etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA IR
Time Frame: 12 months after inclusion (baseline)
Insulin resistance according to HOMA
12 months after inclusion (baseline)

Collaborators and Investigators

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

Sponsor

Göteborg University

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

October 1, 2009

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIAVIP-1204
  • Swedish Research Council (Other Grant/Funding Number: Swedish Research Council)

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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