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

NCT ID: NCT05060978

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-02-11

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.

Conditions

Weight Gain; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Watch your Weight During the Holidays Program

Group Type: ACTIVE_COMPARATOR

Watch your Weight During the Holidays Program

Intervention Type: BEHAVIORAL

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 Fasting

Group Type: ACTIVE_COMPARATOR

Relative 5:2 Fasting

Intervention Type: OTHER

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 Group

Group Type: PLACEBO_COMPARATOR

Control Group

Intervention Type: OTHER

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).

Interventions

Watch your Weight During the Holidays Program

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.

Intervention Type: BEHAVIORAL

Relative 5:2 Fasting

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.

Intervention Type: OTHER

Control Group

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Sonora

OTHER

Sponsor Role: lead

Responsible Party

Rolando Giovanni Díaz Zavala

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolando G Díaz Zavala, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Sonora

Locations

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, Mexico

Countries

Mexico

Other Identifiers

USO313007128

Identifier Type: -

Identifier Source: org_study_id