Evaluation of the Efficacy of the Watch Your Weight During Holidays Program for the Prevention of Body Weight Gain in Mexican Adults.

Evaluation of the Efficacy of the Watch Your Weight During Holidays Program for the Prevention of Body Weight Gain in Mexican Adults: Two-arm Randomized Controlled Trial With Parallel Groups.

Obesity is the main risk factor for the development of chronic-degenerative diseases in Mexico. Due to the difficulty of treating obesity, prevention is urgently needed. The holidays are the festive period with the greatest impact on adult body weight. Evidence from observational studies has shown that more than 50% of the annual weight is gained during this period. However, few preventive interventions have been carried out worldwide. The present work will evaluate the efficacy of the Watch your Weight During Holidays Program on the prevention of weight gain during 8 weeks in comparison with the control group in Mexican adults. The study will be a randomized clinical trial. It will have two intervention groups: 1) Watch your Weight During Holidays Program and 2) Control Group (minimal intervention). Weight, height, body mass index, waist circumference, kilograms of body fat, fat mass index, cm2 of abdominal fat, blood pressure and perception of health-related quality of life will be measured in 64 volunteers, at the beginning and after 8 weeks of participating in Watch your Weight During Holidays Program. For comparisons between groups, Student's t-tests or Mann-Whitney's U-tests will be performed, according to the type of sample distribution. The primary variable of the study will be the change in body weight. The secondary variables will be the change in body mass index, waist circumference, kilograms of fat mass, fat mass index, cm2 of abdominal fat, blood pressure and aspects of perception of quality of life related to health.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight; Weight Gain
• Intervention / Treatment: Behavioral: Watch your Weight During Holidays; Other: Control Group (minimal intervention)

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rolando G Díaz Zavala, Ph.D.; Phone Number: 4632 (52)6622893793; Email: giovanni.diaz@unison.mx

Study Locations

• Mexico
  • Sonora
    • Hermosillo, Sonora, Mexico, 83000
      • Recruiting
      • Centro de Promoción de Salud Nutricional (CPSN)
      • Contact: Rolando G Díaz-Zavala, Ph.D.; Phone Number: 4632 6622893793; Email: giovanni.diaz@unison.mx
      • Principal Investigator: Rolando G Díaz-Zavala, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults (≥18 and ≤60 years of age).
• Residents of the city of Hermosillo, Sonora.
• BMI ≥ 23 and ≤ 40.
• Availability of time to participate in the study, including initial and final measurements.
• Have a device with access to WhatsApp
• Accept not to carry out any other intervention outside of the one assigned in the study during the 8 weeks of the intervention.

Exclusion Criteria:

• Have medical conditions due to previous diagnosis, which require the prescription of treatments that affect weight, such as diabetes and thyroid diseases.

Other exclusion criteria will be liver failure, cancer under treatment or at an advanced stage, a history of COVID-19 that has required hospitalization, supplemental oxygen or left sequelae that contraindicate 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Watch your Weight During Holidays Program	Behavioral: Watch your Weight During Holidays; Participants in this group will have an individual face-to-face session (with a maximum duration of half an hour) and a face-to-face group session. This intervention will include strategies for self-monitoring (body weight, diet and physical activity), information on healthy lifestyles, as well as information about the energy contained in local festive foods and their equivalent in minutes of physical activity or steps per day. Participants will be asked to weight themselves at least twice a week, as a form of self-monitoring of weight, from the start of the intervention. They will have access to weekly forms with boxes, where they can fill in the data obtained for each day of weight self-monitoring, energy intake restriction report and minutes of physical activity performed.
Placebo Comparator: Control group (minimal intervention)	Other: Control Group (minimal intervention); Participants in this group will receive a printed information, as well as a PDF file, brochure during a face-to-face session at the beginning of the 8-week period. This information will be about having a healthy eating based on the norm for health promotion and education for healthy eating in Mexico (NOM-043-SSA2-2012).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in body weight	Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body mass index		Baseline to 8 weeks
Changes in waist circumference		Baseline to 8 weeks
Changes in kilograms of body fat		Baseline to 8 weeks
Changes in body fat index		Baseline to 8 weeks
Changes in cm2 of abdominal fat		Baseline to 8 weeks
Changes in systolic blood pressure		Baseline to 8 weeks
Changes in diastolic blood pressure		Baseline to 8 weeks
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 to 8 weeks

Collaborators and Investigators

• Sponsor: Rolando Giovanni Díaz Zavala

Study record dates

Study Major Dates

• Study Start (Anticipated): October 11, 2022
• Primary Completion (Anticipated): January 13, 2023
• Study Completion (Anticipated): January 13, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Prevention; Holiday Season
• Additional Relevant MeSH Terms: Body Weight Changes; Overweight; Body Weight; Weight Gain
• Other Study ID Numbers: USO313008171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No