Brazilian Diabetes Prevention Program: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 5
- 主要终点
- Minutes of Moderate Physical activity
研究概览
简要总结
To structure a Brazilian Diabetes Prevention Program based on guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using materials already developed by the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System (SUS) and evaluating its effectiveness in a multicentric randomized clinical trial with 220 pre-diabetic patients and a follow up of 3 months. Outcomes are diet quality and time of physical activity. Health care professionals' perceptions regarding its incorporation into clinical practice will also be evaluated.
详细描述
This is a multicentric randomized clinical study coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).
The study's objective is the Brazilian Diabetes Prevention Program development based on guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using materials already developed by the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System (SUS).
The program will not include a multidisciplinary orientation, but the prescription will have a multi-professional vision. The objective is to bring the multi-team together to discuss different aspects of the same intervention, such as accessibility, motivation, contexts, and needs, so that the program, to be guided by the nutritionist, can also be recognized and supported by the other teammates.
Once the program is defined, the research teams from the collaborating centers will be trained and qualified. 220 individuals with pre-diabetes will be included in the study and followed for 3 months. Outcomes are diet quality and time of physical activity. Health care professionals' perceptions regarding its incorporation into clinical practice will also be evaluated.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index greater than or equal to 24kg/m2
- •Have one of the following criteria: (CDC criteria for participating in the DPP)
- •Diagnosis of prediabetes or
- •Fasting blood glucose between 100-125mg/dl or blood glucose 2h after oral glucose tolerance test between 140 and 199mg/dl or HbA1c between 5.7 and 6.4% (maximum test date: last 3 months) or
- •Previously diagnosed with gestational diabetes or
- •High risk on the CDC prediabetes risk test
- •With Internet access
- •With personal cell phone access
- •No prior nutritional monitoring (6 months)
- •Live at least 60 minutes from the survey call center
排除标准
- •Diagnosis of Diabetes Mellitus
- •In secondary prevention for cardiovascular disease
- •HIV patient with detectable viral load (amount of virus greater than 40 copies per ml of blood)
- •Presence of illnesses that could seriously reduce your life expectancy or your ability to participate in the study
- •Refuse to participate in the study (signing the Free and Informed Consent Form)
- •Participation in another Randomized Clinical Trial whose objective interferes with the primary outcome of this research, such as diet quality and physical activity level
- •Pregnant and lactating women
结局指标
主要结局
Minutes of Moderate Physical activity
时间窗: 3 months
to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups
Quality of diet
时间窗: 3 months
to compare mean score of Brazilian Cardioprotective Nutritional Program dietary index (BALANCE DI) between groups. the index has a score from 0 to 40, with a high score indicating adherence to a healthy diet (BALANCE).
次要结局
- Moderate or vigorous physical activity (according to IPAQ-short)(3 months)
- weight(3 months)
- Glycemia(3 months)
- Cardioprotective diet adherence(3 months)
- Implementation Barriers and Facilitators(3 months)
- Global DNA Methylation(Baseline and 3 months)
- HbA1c(3 months)