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

Terminated NA Last updated 16 May 2023

What this trial tests

NA trial testing Watch your Weight During the Holidays Program in Weight Gain in 32 participants. Terminated before completion.

Timeline

10 November 2021

Primary endpoint
11 February 2022

11 February 2022

Quick facts

Lead sponsor	Universidad de Sonora
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	32
Start date	10 November 2021
Primary completion	11 February 2022
Estimated completion	11 February 2022
Sites	1 location across Mexico

Drugs / interventions tested

• Watch your Weight During the Holidays Program
• Relative 5:2 Fasting
• Control Group — full drug profile →

Conditions studied

• Weight Gain — all drugs for Weight Gain →
• Overweight — all drugs for Overweight →
• Obesity — all drugs for Obesity →

Sponsor

Universidad de Sonora

Who can join

Adults 20 to 60, any sex, with Weight Gain or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.