Evaluation of the Efficacy of the Planetary Health Diet Included in an Intensive Lifestyle Change Program on Weight and Body Fat at 4 Months in Mexican Adults With Overweight or Obesity in an Online Modality: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in body fat
研究概览
简要总结
The EAT-Lancet Commission proposed the planetary health diet as a strategy to achieve health and sustainability goals. Currently, its effect in the treatment of obesity has not been evaluated. The main aim is to evaluate the efficacy of the planetary health diet included in an intensive lifestyle change program compared to a waiting list group, on weight and body fat at 4 months, in Mexican adults with overweight or obesity, in an online modality. This study is a 4-month randomized controlled trial, in an online modality in individuals with overweight or obesity randomly assigned 1:1:1 to one of three groups: 1) planetary health diet, 2) waiting list and 3) low fat-diet. The primary outcome is the difference in change in weight (kg) and body fat (kg) at 4 months between the planetary health diet group and the waiting list group. Comparison with the low-fat diet group will be an exploratory analysis. Secondary variables include changes in waist circumference, BMI, blood pressure, and health-related quality of life. Between group comparisons will be analyzed by intention-to-treat. The protocol was approved by a Research Bioethics Committee.
详细描述
The present study is a randomized controlled trial of parallel groups and superiority. The sample will consist of 60 participants (20 participants for each arm of the study), calculated from previous studies of our research group. The intervention groups will be 1) planetary health diet, 2) waiting list group, and 3) low-fat diet.
Participants will be measured at the start of the study and at 4 months. The participants of the two diets will follow the Diabetes Prevention Program (DPP) adapted to the Mexican population and its online application. It has also been adapted for the planetary health diet group.
Participants will receive 13 online group educational sessions over 4 months (1 per week) and at least one individual session per week. They will receive a meal plan according to the dietary group to which they belong, with a calorie range from 1200 to 1800 kcal.
Participants in the waiting list group will receive digital information on healthy eating. Upon completion of the study, they will be invited to participate in the "Lifestyle Balance Program" offered at the Nutritional Health Promotion Center, which is an adaptation of the DPP. During the 4 months, there won't be any contact with this group.
The analysis of the primary and secondary outcomes will be carried out in a conservative way by intention to treat and also by completers analysis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mexican adults (≥18 and ≤60 years).
- •Residents of the city of Hermosillo, Sonora.
- •BMI ≥ 25 kg/m2 and ≤ 40 kg/m
- •Availability of time to participate in the study
- •Have an electronic device with internet access
- •Completion of a dietary record for at least 2 days prior to the intervention.
- •Active Facebook account, telephone number, WhatsApp and/or e-mail address
- •Basic computer skills
排除标准
- •Illiteracy
- •Present health conditions due to previous diagnosis with effect on body weight, or that prevent adherence to the intervention (Diabetes, hypertension with values ≥ 150/95 mm Hg, liver failure)
- •Pregnancy or lactation.
- •History of weight loss in the last 4 months of > 5% of total body weight.
- •Being 10% below usual weight.
- •Surgeries aimed at weight and/or body fat reduction.
- •Use of medications or substances with effect on body weight, e.g. metformin, orlistat, corticosteroids, etc.
- •Use of addictive substances
- •Plan to change residence during the 4 months of the study.
- •Other family member who has agreed to participate in the study.
- •History of COVID-19 that required hospitalization or needed for supplemental oxygen or developed sequelae that precludes intervention.
结局指标
主要结局
Change in body fat
时间窗: baseline and 4 months
Kilograms of total body fat will be obtained by SECA mBCA model 514 digital scale.
Change in body weight
时间窗: baseline and 4 months
To obtain weight (kg), a SECA mBCA model 514 digital scale will be used.
次要结局
- Change in the Short Form-36 Health Survey score(baseline and 4 months)
- Change in waist circumference(baseline and 4 months)
- Change in systolic and diastolic blood pressure(baseline and 4 months)
- Adherence to intervention(up to 16 weeks)
- Retention / desertion(4 months)
- Change in body mass index(baseline and 4 months)
研究者
Rolando Giovanni Díaz Zavala
Doctor
Universidad de Sonora