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

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ClinicalTrials.gov Identifier: NCT00903500
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : May 19, 2009
Sponsor:
Collaborator:
BOF
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Daily physical activity, pedometer and counseling Behavioral: Usual care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
Study Start Date : July 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Daily physical activity
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

No Intervention: 2
Usual care
Behavioral: Usual care
Usual care




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Dexa scan [ Time Frame: At baseline, after the intervention (six months) and one year after baseline ]

Secondary Outcome Measures :
  1. Questionnaires on psycho-social determinants of physical activity, on environmental determinants of physical activity and a motivational questionnaire [ Time Frame: At baseline, after the intervention and one year after baseline ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903500


Locations
Belgium
Univerversity Ghent
Ghent, Belgium
Sponsors and Collaborators
University Ghent
BOF
Investigators
Principal Investigator: Ilse De Bourdeaudhuij University Ghent

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ilse De Bourdeaudhuij, University Ghent
ClinicalTrials.gov Identifier: NCT00903500     History of Changes
Other Study ID Numbers: 2005/380
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: May 19, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases