Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- a weight loss of 7% in at least 19% of the subjects
研究概览
简要总结
This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes.
This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.
详细描述
Eligible participants will be randomized into 2 intervention groups (30 per group):
- Small Meeting groups: a curriculum of 25 meeting-seminars will take place for 45 minutes, each one approaching various aspects of nutrition, physical activity, psychology, motivation and medical needs. These seminars are administered by the professionals of the obesity clinic and are already in place. However, these are usually only offered to the patients registered with the obesity clinic.
- Obesity Clinic of CHUS: combination of 25 described meeting-seminars see-high, in addition to individual interviews every 6 weeks with the interdisciplinary team of the obesity clinic of CHUS (usual operation).
Subjects will be evaluated initially and then every 3 months during 1 year by the following measurements: questionnaires to evaluate motivation and physical activity; 3 day dietary journals; weight assessment, using both metabolic and mechanical balance; waist circumference; and blood pressure.
A medical evaluation with size measure, a test evaluating knowledge of the participants on obesity, OGTT (Oral Glucose Tolerance Test) - a 5 hour determination of secretion and resistance to insulin, insulin-mediated suppression of plasma non-esterified fatty acids, a plasma lipid profile, accelerometry, bio electric impedance, and an activity physical test (6 minute walk test) will be carried out initially, and then repeated for up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pre diabetic state underlined by a marginal fasting glycemia between 6,1 and 6,9 mmol/L and/or a glucose intolerance with glucose confirmed by an OGTT 2 hours
- •overweight or obesity (BMI > 27 kg/m² ; (Body Mass Index))
- •enlightened assent
排除标准
- •Impossibility to be present at the visits
- •Physical/motor incapacity (or other) making one unable and/or insecure to walk at a moderate to rapid speed of 6 min and more
- •Use of an anti-obesity treatment during the last 3 months
- •Bariatric Surgery in the past
- •Planned Pregnancy
- •Pacemaker
结局指标
主要结局
a weight loss of 7% in at least 19% of the subjects
时间窗: one year
reduced body weight of at least 5.6 kg in at least 25% of the subjects
时间窗: one year
an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects
时间窗: one year
a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects
时间窗: one year
a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects
时间窗: one year
次要结局
- change in insulin sensitivity by HOMA(one year)
- change in insulin secretion during an OGTT by deconvolution of plasma c-peptide(one year)
- change in beta cell function by calculation of the disposition index(one year)
- change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT(one year)
- relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids(one year)