Clinical trial NCT05060978: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Weight Gain
Overweight
Obesity
Keywords: Holiday Season
Normal weight
Prevention
Lead sponsor: Universidad de Sonora
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in body weight
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Changes in body weight
timeFrame: Baseline and 52 weeks
measure: Changes in kilograms of body fat
timeFrame: Baseline, 8 weeks and 52 weeks
measure: Changes in waist circumference
timeFrame: Baseline, 8 weeks and 52 weeks
measure: Changes in systolic blood pressure
timeFrame: Baseline, 8 weeks and 52 weeks
measure: Changes in diastolic blood pressure
timeFrame: Baseline, 8 weeks and 52 weeks
measure: Changes in perception of health related quality of life
timeFrame: Baseline, 8 weeks and 52 weeks
measure: Retention / desertion
timeFrame: 8 weeks and 52 weeks
measure: Adherence to intervention
timeFrame: 8 weeks and 52 weeks
measure: Participant satisfaction scale
timeFrame: 8 weeks and 52 weeks
measure: Changes in fasting glucose
timeFrame: Baseline and 8 weeks
measure: Changes in total cholesterol
timeFrame: Baseline and 8 weeks
measure: Changes in LDL cholesterol
timeFrame: Baseline and 8 weeks
measure: Changes in HDL cholesterol
timeFrame: Baseline and 8 weeks
measure: Changes in triglycerides
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Promoción de Salud Nutricional (CPSN)
state: Sonora
Study officials:
affiliation: Universidad de Sonora
name: Rolando G Díaz Zavala, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: