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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Daily physical activity, pedometer and counseling

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Univerversity Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2; Usual care
Experimental: 1; Daily physical activity	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical activity measured with an accelerometer, pedometer en the International Physical Activity Questionnaire (IPAQ)	At baseline, after the intervention (at 6 months) and one year after baseline
Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height	At baseline, after the intervention (at 6 months) and one year after baseline
Blood samples taken to determine:HBA1C, glucose, insulin, leptin, c-peptide, IGF-1, total cholesterol, HDL-c, LDL-C, triglycerides, APo-B, high sensitive C-reactive protein, vrij-t, DHEAS Oestradiol, Shbg, LH, FSH	At baseline, after the intervention (six months) and one year after baseline
Dexa scan	At baseline, after the intervention (six months) and one year after baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Questionnaires on psycho-social determinants of physical activity, on environmental determinants of physical activity and a motivational questionnaire	At baseline, after the intervention and one year after baseline

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: BOF
• Investigators: Principal Investigator: Ilse De Bourdeaudhuij, University Ghent

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Website of the University Ghent

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 15, 2009
• First Posted (Estimate): May 18, 2009

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2005/380