Clinical trial NCT00903500: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: BOF
First posted: 2009-05-18
Enrollment: 92
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Physical activity measured with an accelerometer, pedometer en the International Physical Activity Questionnaire (IPAQ)
timeFrame: At baseline, after the intervention (at 6 months) and one year after baseline
measure: Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height
timeFrame: At baseline, after the intervention (at 6 months) and one year after baseline
measure: 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
timeFrame: At baseline, after the intervention (six months) and one year after baseline
measure: Dexa scan
timeFrame: At baseline, after the intervention (six months) and one year after baseline
Secondary outcomes:
measure: Questionnaires on psycho-social determinants of physical activity, on environmental determinants of physical activity and a motivational questionnaire
timeFrame: At baseline, after the intervention and one year after baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Univerversity Ghent
Study officials:
affiliation: University Ghent
name: Ilse De Bourdeaudhuij
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.