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

This study has been completed.
Sponsor:
Collaborator:
BOF
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00903500
First received: May 15, 2009
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

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 Intervention
Type 2 Diabetes
Behavioral: Daily physical activity, pedometer and counseling
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Dexa scan [ Time Frame: At baseline, after the intervention (six months) and one year after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903500

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

Additional Information:
No publications provided by University Ghent

Additional 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
Study First Received: May 15, 2009
Last Updated: May 18, 2009
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014