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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00903500
Enrollment
92
Registered
2009-05-18
Start date
2007-07-31
Completion date
2008-12-31
Last updated
2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

BEHAVIORALDaily 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

Sponsors

BOF
CollaboratorUNKNOWN
University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
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
Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, heightAt 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, FSHAt baseline, after the intervention (six months) and one year after baseline
Dexa scanAt baseline, after the intervention (six months) and one year after baseline

Secondary

MeasureTime frame
Questionnaires on psycho-social determinants of physical activity, on environmental determinants of physical activity and a motivational questionnaireAt baseline, after the intervention and one year after baseline

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026