Application of Dietary Guidelines for the Brazilian Population by Teleconsultation for Patients With Obesity in Primary Health Care: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 578
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
Obesity is a chronic disease that is highly prevalent in Brazil. It is associated with diabetes and hypertension. Obesity may decrease quality of life. Communication tools, such as mobile devices and social media, are helping to control and prevent obesity. In this 2-arm randomized clinical trial, the investigators aim to evaluate the efficacy of the Dietary Guidelines for the Brazilian Population through 8 weekly video nutritional monitoring sessions with nutritionists. Both groups will receive guidance from reference professionals from primary health care (physician and nurse). Throughout the intervention program, both groups will be equally evaluated in order to verify at the end of the study effectiveness in weight loss and life quality improvement.
详细描述
Obesity is a multifactorial disease of epidemic proportions worldwide. The use of telecommunication tools has been used in health and nutrition in different contexts, seeking to reduce the burden of non-communicable chronic diseases. Telehealth interventions are effective to increase quality of life and to improve the dietary food intake of participants; this kind of treatment seems feasable, cost-effective and has promising results to induce weight loss in obese individuals. This project will evaluate the impact of a remote nutritional intervention in short (8 weeks) and long term (24 and 48 weeks) on the weight fo obese individuals. The intervention will be based on the Dietary Guidelines for the Brazilian Population. It will focus on primary care patients and will have a multidisciplinary approach. It is an open-label pragmatic multicentre randomized controlled trial, with an 1:1 allocation: (1) intervention group (n = 289): Remote consultation with nutritionists based on the Dietary Guidelines for the Brazilian Population; (2) control group (n = 289): usual follow-up in Primary Health Care (PHC). The primary outcome will be weight change at 8 weeks. Additionally, the investigators will evaluate food consumption and quality of life at 8 and 24 weeks as secondary outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male individuals, with BMI ≥30 kg/m²;
- •Age over 18 years;
- •Internet access by phone or tablet or computer and WhatsApp multi-platform application (Facebook Inc.);
- •Weekly time availability (10-20 minutes).
排除标准
- •Individuals who do not have access to the WhatsApp multi-platform application (Facebook Inc.).
研究组 & 干预措施
Control Group
Patients into the control group will receive the same assessments as patients in the intervention group, for the same time (in 1th, 8th, 24, and 48 weeks), but they will not receive nutritional teleconsultation.
Intervention Group
Teleintervention based on Dietary Guidelines for the Brazilian Population during 8 weeks; two subsequent assessments will also be made, in 24th and 48th weeks, to assess the maintenance of weight loss.
干预措施: Teleobesity (Behavioral)
结局指标
主要结局
Weight change
时间窗: 8 weeks
Weight change, measured using a calibrated scale at a Primary Health Care health unit, at the end of 8 weeks.
次要结局
- Weight change (follow up)(24 and 48 weeks)
- Quality of life measured using the Short Form Health Survey 36(8 and 24 weeks)
- Food consumption improvement(8 and 24 weeks)