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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Daily physical activity, pedometer and counseling

• Registration Number: NCT00903500
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-15
• Study First Posted: 2009-05-18
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Daily physical activity, pedometer and counseling	Daily physical activity

Primary Outcome Measures

Name	Time	Method
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
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
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
Dexa scan	At baseline, after the intervention (six months) and one year after baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Univerversity Ghent; 🇧🇪 Ghent, Belgium