NCT05580926

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Rolando Giovanni Díaz Zavala · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Weight Gain
• Overweight

Interventions

Type	Name	Description
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.
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).

Timeline

• Start date: 2022-10-11
• Primary completion: 2023-01-13
• Completion: 2023-01-13
• First posted: 2022-10-14
• Last updated: 2022-10-18

Locations

1 site across 1 country: Mexico