Evaluation of the Efficacy of the Diabetes Prevention Program With a Very-low-energy Diet or a Low-energy Diet on Body Weight at 4 Months in Mexican Adults With Obesity: Two-armed-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in body weight
研究概览
简要总结
Clinical practice guidelines recommend behavioral change protocols for obesity treatment, such as the Diabetes Prevention Program, which involves a low-energy diet, physical activity recommendations, behavioral therapy, and frequent visits. Weight losses of 7-9% per year have achieve with this type of intervention. However, evidence suggests that a very low-energy diet may reach 10-15% weight loss and conduce superior clinical effects. Therefore, the objective will be to evaluate the efficacy of the Diabetes Prevention Program with a very-low energy diet and a low-energy diet on body weight change at four months in Mexican adults with obesity. The study will be a randomized controlled trial. Participants will be randomized to an intensive lifestyle change program with a very low-energy diet or an intensive lifestyle change program with a low-energy diet. The primary outcome will be a change in body weight. Secondary outcomes will be changes in waist circumference, body mass index, total body fat, fat-free mass, abdominal fat, blood pressure, and quality of life. Data will be analyzed on an intention-to-treat (ITT) using Student's t-tests or Mann-Whitney's U-test. The protocol was performed following the SPIRIT guidelines. Ethical approval was obtained from the Research Ethics Committee of the Department of Medicine of the University of Sonora.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 and ≤55 years of age).
- •Residents of the city of Hermosillo, Sonora.
- •BMI ≥ 30 and ≤
- •Availability of time to participate in the study, including initial and final measurements.
- •Have a device with access to the internet
- •Availability and possibility to acquire the indicated diet
- •Send a report of food consumption for three days
排除标准
- •Being a participant in a weight loss program.
- •Weight loss major than 5% in the last six months.
- •Have type 2 diabetes or hypertension (previous).
- •Use of drugs with an effect on body weight ( steroids, injectable progestins, lithium, valproic acid, carbamazepine, antipsychotics, antidepressants, thiazolidinediones, levothyroxine, metformin, and anorexigenic drugs).
- •Have a history of coronavirus disease with hospitalization or the presence of sequelae that prevent the intervention from being carried out.
- •Have cancer, kidney disease, eating disorders, psychiatric disorder (depression) or other serious diseases, active biliary disease, or known asymptomatic gallstones.
- •Pregnancy or breastfeeding.
- •Use of medications for obesity.
- •Use of illegal substances harmful to health (drugs).
- •Illiteracy.
结局指标
主要结局
Changes in body weight
时间窗: Baseline to 16 weeks
SECA medical body composition analyzer (mBCA) model 514 digital scale will be used. The participant should wear light clothing, remove footwear and metal objects, and have omitted food and beverages two hours before the measurement.
次要结局
- Changes in body mass index(Baseline to 16 weeks)
- Changes in waist circumference(Baseline to 16 weeks)
- Changes in fat-free mass(Baseline to 16 weeks)
- Changes in abdominal fat(Baseline to 16 weeks)
- Changes in diastolic blood pressure(Baseline to 16 weeks)
- Changes in body fat(Baseline to 16 weeks)
- Changes in systolic blood pressure(Baseline to 16 weeks)
- Changes in perception of health-related quality of life(Baseline to 16 weeks)
研究者
Rolando Giovanni Díaz Zavala
Research Professor
Universidad de Sonora