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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Daily physical activity, pedometer and counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Daily physical activity | Behavioral: Daily physical activity, pedometer and counseling<br>* 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<br>|
| No Intervention: 2<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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, 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |