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

Sponsor
University Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT00903500
Collaborator
BOF (Other)
92
1
2
17.1
5.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Daily physical activity, pedometer and counseling
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

No Intervention: 2

Usual care

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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]

  4. Dexa scan [At baseline, after the intervention (six months) and one year after baseline]

Secondary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Univerversity Ghent Ghent Belgium

Sponsors and Collaborators

  • University Ghent
  • BOF

Investigators

  • Principal Investigator: Ilse De Bourdeaudhuij, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT00903500
Other Study ID Numbers:
  • 2005/380
First Posted:
May 18, 2009
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021