Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
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
Daily physical activity
干预措施: Daily physical activity, pedometer and counseling (Behavioral)
2
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)
