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

NCT ID: NCT05580926

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2023-01-13

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.

Conditions

Obesity; Weight Gain; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Watch your Weight During Holidays Program

Group Type: EXPERIMENTAL

Watch your Weight During Holidays

Intervention Type: BEHAVIORAL

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.

Control group (minimal intervention)

Group Type: PLACEBO_COMPARATOR

Control Group (minimal intervention)

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rolando Giovanni Díaz Zavala

OTHER

Sponsor Role: lead

Responsible Party

Rolando Giovanni Díaz Zavala

Research Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Rolando G Díaz Zavala, Ph.D.

Role: CONTACT

giovanni.diaz@unison.mx

(52)6622893793 ext. 4632

Facility Contacts

Rolando G Díaz-Zavala, Ph.D.

Role: primary

giovanni.diaz@unison.mx

6622893793 ext. 4632

Other Identifiers

USO313008171

Identifier Type: -

Identifier Source: org_study_id