Skip to main content
OpenTrials
Completed

NCT Number: NCT00903500

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univerversity Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daily physical activity, pedometer and counseling

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • BOF

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 18, 2009
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.