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临床试验/NCT00903500
NCT00903500已完成不适用

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

University Ghent1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2007年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

Daily physical activity

干预措施: Daily physical activity, pedometer and counseling (Behavioral)

2

No Intervention

Usual care

结局指标

主要结局

Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height

时间窗: At baseline, after the intervention (at 6 months) and one year after baseline

Physical activity measured with an accelerometer, pedometer en the International Physical Activity Questionnaire (IPAQ)

时间窗: 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

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

Dexa scan

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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