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

NCT00903500 | Completed

• 1 other identifier: 2005/380
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

• 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, height

  At 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, FSH

  At baseline, after the intervention (six months) and one year after baseline

• Dexa scan

  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

  At baseline, after the intervention and one year after baseline

Study Arms (2)

1

EXPERIMENTAL

Daily physical activity

Behavioral: Daily physical activity, pedometer and counseling

2

NO INTERVENTION

Usual care

Interventions

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

1

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• BOF: collaborator

Study Sites (1)

Univerversity Ghent

Ghent, Belgium

Location

Related Publications (2)

• 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.

  PMID: 21958233 DERIVED

• 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.

  PMID: 21052886 DERIVED

Related Links

• Website of the University Ghent

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Counseling

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ilse De Bourdeaudhuij

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 18, 2009
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

BE (1)