Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Ghent
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Exclusion Criteria
- Not provided
Arms & Interventions
1
Daily physical activity
Intervention: Daily physical activity, pedometer and counseling (Behavioral)
2
Usual care
Outcomes
Primary Outcomes
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
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
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
Dexa scan
Time Frame: At baseline, after the intervention (six months) and one year after baseline
Secondary Outcomes
- 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)