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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903500
• Other study ID #: 2005/380
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Belgium	Univerversity Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	BOF

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Dexa scan		At baseline, after the intervention (six months) and one year after baseline
Secondary	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

External Links

•   Website of the University Ghent