Health Promotion in the Primary Care Setting- an Evaluation of the Sophia Step Study- a Structured Behaviour Change Program Focusing on Physical Activity in Persons With Pre- and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- HbA1c (mmol/mol)
研究概览
简要总结
The aim of the study is to investigate the effects of two levels of primary care physical activity interventions on metabolic control and cardiovascular risk factors, compared to usual care in patients with pre- and type 2 diabetes.
The hypothesis is that both levels of interventions have effect on HbA1c with the more intense Group intervention having superior effects.
详细描述
Regularly physical activity may decrease the risk for type 2 diabetes, cardiovascular diseases, overweight and premature deaths. Despite the evidence that physical activity is beneficial to health,it is often ignored and underused aspect in diabetes care. The aim of the study is to investigate the effects of two levels of primary care physical activity interventions on metabolic control and cardiovascular risk factors, compared to usual care in patients with pre- and type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to communicate in Swedish Age 40-80 years Type 2 diabetes: Diagnosed type 2 diabetes with a duration of >=1 year Pre-diabetes: HbA1c >39-<47, Fasting plasma glucose >5.6 mmol/l
排除标准
- •Myocardial infarction in the past 6 months
- •serum creatinine >140
- •diabetic ulcer or risk for ulcer
- •prescribed insulin in past 6 months
- •additional disease prohibiting physical activity
- •have experienced repeated hypoglycaemia or severe hypoglycaemia in past 12 months
- •classified in very hard-intensity activity according to Stanford Brief Activity Survey
- •having no access to internet.
结局指标
主要结局
HbA1c (mmol/mol)
时间窗: up to month 24.
Haemoglobin A1c
次要结局
- ApoA1 (g/l)(week 0, 24 and month 24.)
- Total cholesterol (mmol/L)(week 0, 12, 24, and month 12 and 24.)
- IGF BP1 (μg/L)(week 0, 12, 24, and month 12 and 24.)
- % Body Fat(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Triglycerides (mmol/L)(week 0, 12, 24, and month 12, 18 and 24.)
- Physical activity level (counts/min)(week 0 and month 6, 12, 18, 24)
- HDL (mmol/L)(week 0, 12, 24, and month 12, 18 and 24.)
- C-peptide (pmol/l)(week 0, 12, 24, and month 12 and 24.)
- Waist circumference (cm)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Change in Smoking and snuffing habits(Evaluation is conducted at baseline and at 24 months after completion of the intervention period)
- fasting plasma glucose (mmol/L)(week 0, 12, 24, and month 9, 12, 18 and 24.)
- Steps/day(week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24.)
- fasting-Insulin (mU/l)(week 0, 12, 24, and month 12 and 24.)
- Free fatty acids (mmol(L )(week 0, 12, 24, and month 12 and 24.)
- ApoB (g/l)(week 0, 24 and month 24.)
- LDL (mmol/L)(week 0, 12, 24, and month 12 and 24.)
- BMI (kg/m2)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Weight (kg)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Sagittal Abdominal Diameter (cm)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Muscle strength(week 0, 12, 24, and month 9, 12, 18 and 24.)
- Resting blood pressure (mmHg)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
研究者
Unn-Britt Johansson
Unn-Britt Johansson
Sophiahemmet University