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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05060978
• Other study ID #: USO313007128
• Status: Terminated
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: May 2023
• Source: Universidad de Sonora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• COVID-19
• Obesity
• Overweight
• Weight Gain

Intervention

Behavioral:
• 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.

Other:
• 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.
• 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).

Locations

Country	Name	City	State
Mexico	Centro de Promoción de Salud Nutricional (CPSN)	Hermosillo	Sonora

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Sonora

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight		Baseline to 8 weeks
Secondary	Changes in body weight		Baseline and 52 weeks
Secondary	Changes in kilograms of body fat		Baseline, 8 weeks and 52 weeks
Secondary	Changes in waist circumference		Baseline, 8 weeks and 52 weeks
Secondary	Changes in systolic blood pressure		Baseline, 8 weeks and 52 weeks
Secondary	Changes in diastolic blood pressure		Baseline, 8 weeks and 52 weeks
Secondary	Changes in perception of health related quality of life	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.	Baseline, 8 weeks and 52 weeks
Secondary	Retention / desertion	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.	8 weeks and 52 weeks
Secondary	Adherence to intervention	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.	8 weeks and 52 weeks
Secondary	Participant satisfaction scale	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.	8 weeks and 52 weeks
Secondary	Changes in fasting glucose		Baseline and 8 weeks
Secondary	Changes in total cholesterol		Baseline and 8 weeks
Secondary	Changes in LDL cholesterol		Baseline and 8 weeks
Secondary	Changes in HDL cholesterol		Baseline and 8 weeks
Secondary	Changes in triglycerides		Baseline and 8 weeks