Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Daily physical activity, pedometer and counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- Univerversity Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Daily physical activity
Usual care
Outcomes
Primary Outcome Measures
Physical activity measured with an accelerometer, pedometer en the International Physical Activity Questionnaire (IPAQ)
Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height
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
Dexa scan
Secondary Outcome Measures
Questionnaires on psycho-social determinants of physical activity, on environmental determinants of physical activity and a motivational questionnaire
Full Information
NCT ID
NCT00903500
First Posted
May 15, 2009
Last Updated
November 18, 2021
Sponsor
University Ghent
Collaborators
BOF
1. Study Identification
Unique Protocol Identification Number
NCT00903500
Brief Title
Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
Official Title
Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
BOF
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Daily physical activity
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Daily physical activity, pedometer and counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
Physical activity measured with an accelerometer, pedometer en the International Physical Activity Questionnaire (IPAQ)
Time Frame
At baseline, after the intervention (at 6 months) and one year after baseline
Title
Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height
Time Frame
At baseline, after the intervention (at 6 months) and one year after baseline
Title
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
Time Frame
At baseline, after the intervention (six months) and one year after baseline
Title
Dexa scan
Time Frame
At baseline, after the intervention (six months) and one year after baseline
Secondary Outcome Measure Information:
Title
Questionnaires on psycho-social determinants of physical activity, on environmental determinants of physical activity and a motivational questionnaire
Time Frame
At baseline, after the intervention and one year after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilse De Bourdeaudhuij
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univerversity Ghent
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
21958233
Citation
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.
Results Reference
derived
PubMed Identifier
21052886
Citation
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.
Results Reference
derived
Links:
URL
http://www.ugent.be
Description
Website of the University Ghent
Learn more about this trial
Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
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