E-coaching for Patients With Abdominal Obesity and Type 2 Diabetes : the A.N.O.D.E. Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- dietary score (International Diet Quality Index)
研究概览
简要总结
Abdominal obesity and its metabolic consequences, particularly type 2 diabetes, require personalized nutritional monitoring. Today, it is not always possible to provide patients with appropriate care to both, the diet plan, physical activity, stress and sleep management. Emerging data have shown the effectiveness of remote support (e- coaching), in order to increase the level of physical activity and reducing calorie intake which causes weight loss similar to that obtained during a face to face consultation. Compared to a food survey conducted by a dietician, the dietary survey MXS computer software showed similar results on the collection of nutritional data. Furthermore, users preferred this method of remote collection compared to direct interview. The investigators recently developed a tool for e-coaching combining this computerized dietary survey and education and support modules on diet and physical activity (MXS- health program) for the patients. The aim of the investigators' study is to compare efficacy of this new software vs usual care.
详细描述
Description of nutritional intervention in both groups:
Both groups make the same visits, answer the same questionnaire and dietary surveys. Only nutrition and physical activity recommendations differ depending on whether the patient is randomized to the intervention group or the control group.
- Intervention group: e-coaching: patients benefit from the MXS-health support program including self-monitoring modules, generation of adequate nutritional recipes, education and support for physical activity. They receive an access code and personal password during the randomization visit
- Control group: usual recommendations: Control subjects will simply follow the usual nutritional recommendations provided during the monitoring of their diabetes. They will be informed of the possibility to benefit from the e-coaching program at the end of the study.
Research hypotheses
Assumptions related to this research are :
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, male or female, aged 18-75 years (inclusive) who agrees to participate in the study and who gave verbal consent
- •Abdominal obesity defined by waist circumference ≥ 102 cm for men and ≥ 88 cm for women
- •Diabetic subject with HbA1C between 5,6% and 8,5% in the month before selection (using venous or capillary blood samples)
- •Subject have already received a standard nutrition education for the treatment of diabetes
- •Initial Food survey showing an estimated average calorie intake between 1200 and 4000 calories
- •Anti-diabetic treatments, antihypertensive or lipid-lowering therapy stable for at least 3 months (at the initial blood test)
- •Subject of a weight and a stable diet, not restrictive in the past 3 months (weight change ≤ 4 kg peak to peak)
- •Affiliated to the social security system or having a similar regime
- •Access to Internet and usual use, possession of an email address
- •Understanding and reading French
排除标准
- •Excessive alcohol consumption (> 30 g / day on average)
- •Symptomatic cardiovascular disease (myocardial infarction, angina pectoris, surgical or endovascular intervention, stroke older than 6 months, symptomatic lower limb arteritis)
- •Subject receiving general or local treatment that may interfere with the assessment of the primary endpoint
- •Situation requiring rapid equilibration of diabetes
- •Subject with any severe or acute illness which may influence the results of the study or to life-threatening
- •Subject in a situation which, in the opinion of the investigator, would interfere with the optimal participation in the study or be a particular risk for the patient
- •Patient who underwent obesity surgery to the exclusion of a gastric band, loosened or removed for more than a year
- •For female subjects: pregnancy or lactation, or subject may become pregnant during the study
- •For female subjects: subject may change hormone treatment under study (contraceptive or hormone replacement)
研究组 & 干预措施
1
Subgroup of subjects who benefit of the e-coaching
干预措施: e-coaching (Behavioral)
2
Subgroup of subjects who are asked to follow the conventional nutritional recommendations of the treatment of abdominal obesity and diabetes
结局指标
主要结局
dietary score (International Diet Quality Index)
时间窗: 4 months
Comparison of the changes between the first (D-20 D-2) and the second survey (D100 to D118) of dietary score (International Diet Quality Index) between both groups (e-coaching versus usual nutritional recommendations).
次要结局
- waist circumference(4 months)
- Physical skills measured by VO2max(4 months)
- Weight(4 months)
- Physical activity (self-administered questionnaire IPAQ)(4 months)
- Blood pressure(4 months)
- Biological parameters: Biological parameters: HbA1c, triglycerides, HDL-C, LDL-C, AST, ALT, uric acid, hs-CRP, adiponectin(4 months)