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Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes

NCT ID: NCT00903500

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-12-31

Brief Summary

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The intervention consists of an individual counseling session, telephone counseling (7 calls), given by a psychologist, and a pedometer. The intervention is based on cognitive behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational Interviewing. The taxonomy of behavior change techniques is also taken into account. The duration of the intervention is six months. The individual session takes place one week after the baseline measurements, together with the participants' follow-up appointment with their endocrinologist. The individual session takes place at the endocrinology department and is expected to last approximately 30 minutes. In addition to the session, the participants of the intervention group receive a pedometer and a pedometer diary for six months. Participants of the intervention group also receive telephone counseling from the psychologist during 24 weeks. They receive a call every two weeks for four weeks and then every four weeks for the next 20 weeks, good for a total of seven counseling calls. The calls are expected to last approximately 20 minutes. The Control Group has no intervention at all and receive their usual care.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Daily physical activity

Group Type EXPERIMENTAL

Daily physical activity, pedometer and counseling

Intervention Type BEHAVIORAL

Individual counseling session, telephone counseling (7 calls), given by a psychologist and a pedometer, based on cognitive behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational Interviewing

2

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Daily physical activity, pedometer and counseling

Individual counseling session, telephone counseling (7 calls), given by a psychologist and a pedometer, based on cognitive behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational Interviewing

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Minimum six months post-diagnosis of type 2 diabetes age between 35 and 75 years
* Treated by diet alone, oral hypoglycaemic medications, insulin or combination therapy
* No documented PA limitations
* Dutch speaking
* Having a telephone number
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BOF

UNKNOWN

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilse De Bourdeaudhuij

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Univerversity Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Van Dyck D, De Greef K, Deforche B, Ruige J, Tudor-Locke CE, Kaufman JM, Owen N, De Bourdeaudhuij I. Mediators of physical activity change in a behavioral modification program for type 2 diabetes patients. Int J Behav Nutr Phys Act. 2011 Sep 29;8:105. doi: 10.1186/1479-5868-8-105.

Reference Type DERIVED
PMID: 21958233 (View on PubMed)

De Greef K, Deforche B, Tudor-Locke C, De Bourdeaudhuij I. Increasing physical activity in Belgian type 2 diabetes patients: a three-arm randomized controlled trial. Int J Behav Med. 2011 Sep;18(3):188-98. doi: 10.1007/s12529-010-9124-7.

Reference Type DERIVED
PMID: 21052886 (View on PubMed)

Related Links

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http://www.ugent.be

Website of the University Ghent

Other Identifiers

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2005/380

Identifier Type: -

Identifier Source: org_study_id