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

Universidad de Sonora32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Interventions

Watch your Weight During the Holidays ProgramBEHAVIORAL

Participants in this group will have two video call individual sessions and one video call group session. This intervention will include self-monitoring strategies (self-weighing, diet monitoring and physical activity), and nutrition counseling and education. In addition, participants in this group will receive a weighing scale to achieve self-monitoring of body weight from the beginning of the study intervention until the end of the 52-weeks follow-up.

Relative 5:2 FastingOTHER

Participants in this group will will have two video call individual sessions and one video call group session. This intervention will receive eating recommendations to follow a 5:2 intermittent fasting. They will be given low-calorie menus of 550 kcal and 660 kcal, for women and men respectively, which the participants in this group will apply on fasting days. The fasting will be held twice a week and on the remaining five days, the participants will not have any type of caloric restriction (it will be ad libitum). They will only have the general recommendation to adhere to a healthy dietary pattern.

Control GroupOTHER

Participants in this group will receive online information and a PDF file brochure during an individual video call session at the beginning of the 8-week period. This information will be about leading a healthy eating based on the norm for health promotion and education for healthy eating in Mexico (NOM-043-SSA2-2012).

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Changes in body weight

Time frame: Baseline to 8 weeks