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

Not Applicable

Recruiting

• Conditions: Weight Gain; Overweight; Obesity
• Interventions: Other: Control Group (minimal intervention); Behavioral: Watch your Weight During Holidays

• Registration Number: NCT05580926
• Lead Sponsor: Rolando Giovanni Díaz Zavala

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-11
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18
• Primary Completion: 2023-01-13
• Study Completion: 2023-01-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (minimal intervention)	Control Group (minimal intervention)	-
Watch your Weight During Holidays Program	Watch your Weight During Holidays	-

Primary Outcome Measures

Name	Time	Method
Changes in body weight	Baseline to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in body fat index	Baseline to 8 weeks
Changes in systolic blood pressure	Baseline to 8 weeks
Changes in kilograms of body fat	Baseline to 8 weeks
Changes in diastolic blood pressure	Baseline to 8 weeks
Changes in waist circumference	Baseline to 8 weeks
Changes in body mass index	Baseline to 8 weeks
Changes in cm2 of abdominal fat	Baseline to 8 weeks
Changes in perception of health related quality of life	Baseline to 8 weeks	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.

Trial Locations

Locations (1)

Centro de Promoción de Salud Nutricional (CPSN); 🇲🇽 Hermosillo, Sonora, Mexico