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
- Conditions
- OverweightObesityWeight Gain
- Interventions
- Behavioral: Watch your Weight During the Holidays ProgramOther: Control Group
- Registration Number
- NCT05060978
- Lead Sponsor
- Universidad de Sonora
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Watch your Weight During the Holidays Program Watch your Weight During the Holidays Program - Control Group Control Group -
- Primary Outcome Measures
Name Time Method Changes in body weight Baseline to 8 weeks
- Secondary Outcome Measures
Name Time Method Changes in diastolic blood pressure Baseline, 8 weeks and 52 weeks Changes in LDL cholesterol Baseline and 8 weeks Changes in systolic 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 The SF-36 Health Survey evaluates aspects of the quality of life in adult populations (over 16 years of age). The result of its application is the generation of eight concepts or scales of health, result of the average of the sum of the questions contained in the questionnaire for each concept. These concepts are: physical function, physical role, corporal pain, general health, vitality, social function, emotional role and mental health. The SF-36 is a self-applied instrument and contains 36 questions. For each scale, the answers to each question are coded and recoded (10 questions), and the results are interpreted on a scale of 0 to 100, lower results indicate poorer health and greater result better health.
Retention / desertion 8 weeks and 52 weeks The retention percentage will be obtained by dividing the number of people that finished the intervention the number that started the intervention, multiplied by 100. The dropout percentage will be obtained by the difference in the number of subjects who started and finished the intervention, multiplied by 100.
Adherence to intervention 8 weeks and 52 weeks Adherence to the intervention will be calculated as the percentage of study measurement appointments and group sessions attended by each participant. Another way to measure adherence to interventions will be with a numerical scale of self-evaluation from 1 to 5, where 1 is the lowest score and 5 is the highest, to indicate how adherent they were to the meal plans.
Participant satisfaction scale 8 weeks and 52 weeks Satisfaction of the participants in each of the intervention groups will be measured online using a scale from 1 to 5, where 1 is the lowest rating and 5 is the highest. A higher score means a higher satisfaction with the intervention recieved.
Changes in total cholesterol Baseline and 8 weeks Changes in HDL cholesterol Baseline and 8 weeks Changes in triglycerides Baseline and 8 weeks
Trial Locations
- Locations (1)
Centro de Promoción de Salud Nutricional (CPSN)
🇲🇽Hermosillo, Sonora, Mexico