Evaluation of the Effect of Two Online Interventions -Watch Your Weight During the Holidays Program and the Relative 5:2 Fasting- for the Prevention of Body Weight Gain at 8 Weeks in Mexican Adults in the Covid-19 Pandemic: A Pilot Three Arm Parallel-Group Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes in body weight
研究概览
简要总结
Introduction. Obesity is the main risk factor for the development of chronic degenerative diseases in Mexico and other countries around the world. Due to the difficulty of treating obesity, it is necessary to change the curative paradigm for a preventive one. A review showed that holiday periods during the year are critical points for weight gain. The holiday season is the festive period with the greatest impact on adults' body weight. Observational studies have shown that more than 50% of the annual weight is gained during this period. However, few preventive interventions in the festive period have been carried out globally. Additionally, the COVID-19 pandemic seems to be negatively affecting diet, physical activity and body weight. So preventive interventions are needed, especially those that can be implemented in an online format. The purpose of the study is to evaluate the effect of two online interventions -Watch your Weight during the Holidays Program and the Relative 5:2 Fasting - on the prevention of body weight gain from baseline to 8 weeks in comparison with a control group in Mexican adults during the COVID-19 pandemic. Methodology: This is a Pilot Randomized Controlled Trial (RCT). The primary outcome is the change in body weight from baseline to 8 weeks. Secondary outcomes are the percentage of retention / desertion of the participants, adherence to interventions, participant satisfaction scale, changes in other obesity parameters, biochemical, physical, and quality of life variables from baseline to 8 weeks. Obesity and quality of life parameters from baseline to 52 weeks are also secondary outcomes. The statistical analysis of the primary and secondary variables will be conducted, according to their distribution, by intention to treat and, secondarily, by completer´s analysis.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mexican adult participants (≥20 and ≤60 years)
- •Residents of the city of Hermosillo, Sonora
- •Body Mass Index ≥ 23 kg/m2 and ≤ 40 kg/m2
- •Availability and motivation to attend the intervention program
- •Committed to not undertake any other intervention in place of, or in combination with, the one assigned in the study during the 8 weeks of the intervention
排除标准
- •Diagnosed medical conditions that constitute a contraindication for intervention such as: diabetes, hypertension, diseases with an effect on body weight (for example: liver failure; cancer in treatment or in advanced stage; history of COVID-19 that required hospitalization, supplemental oxygen or has left sequelae that contraindicates the intervention; psychiatric conditions; eating disorders, etc.).
- •Use of drugs or substances with an effect on weight, for example, metformin, orlistat, corticosteroids, etc.
- •Use of addictive substances such as drugs of abuse
- •Previous bariatric surgery.
- •Being a participant in another intervention or treatment for the management of obesity.
- •Weight loss > 5% of total body weight in the last 4 months.
- •Having plans to become pregnant within the study period, currently pregnant or breastfeeding.
- •Another family member has agreed to participate in the study.
- •Illiteracy.
结局指标
主要结局
Changes in body weight
时间窗: Baseline to 8 weeks
次要结局
- Changes in systolic blood pressure(Baseline, 8 weeks and 52 weeks)
- Changes in diastolic blood pressure(Baseline, 8 weeks and 52 weeks)
- Changes in body weight(Baseline and 52 weeks)
- Changes in kilograms of body fat(Baseline, 8 weeks and 52 weeks)
- Changes in waist circumference(Baseline, 8 weeks and 52 weeks)
- Changes in fasting glucose(Baseline and 8 weeks)
- Changes in perception of health related quality of life(Baseline, 8 weeks and 52 weeks)
- Retention / desertion(8 weeks and 52 weeks)
- Adherence to intervention(8 weeks and 52 weeks)
- Changes in LDL cholesterol(Baseline and 8 weeks)
- Participant satisfaction scale(8 weeks and 52 weeks)
- Changes in total cholesterol(Baseline and 8 weeks)
- Changes in HDL cholesterol(Baseline and 8 weeks)
- Changes in triglycerides(Baseline and 8 weeks)
研究者
Rolando Giovanni Díaz Zavala
Research Professor
Universidad de Sonora