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

NCT05580926 | Unknown

• 1 other identifier: USO313008171
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

Holiday Season; Prevention

Outcome Measures

Primary Outcomes (1)

• Changes in body weight

  Baseline to 8 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

Watch your Weight During Holidays Program

EXPERIMENTAL

Behavioral: Watch your Weight During Holidays

Control group (minimal intervention)

PLACEBO COMPARATOR

Other: Control Group (minimal intervention)

Interventions

Watch your Weight During Holidays 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.

Watch your Weight During Holidays Program

Control Group (minimal intervention) 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).

Control group (minimal intervention)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rolando Giovanni Díaz Zavala: lead

Study Sites (1)

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, 83000, Mexico

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Gain; Overweight

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Rolando G Díaz Zavala, Ph.D.

CONTACT

(52)6622893793; giovanni.diaz@unison.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors of the variables of interest will be blinded to the allocation group. The person responsible for randomization will be external, not involved in recruitment, study measurements and intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: October 11, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

ME (1)