Clinical trial NCT05580926: Evaluation of the Efficacy of the Watch Your Weight During Holidays Program for the Prevention of Body Weight Gain in Mexican Adults.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Weight Gain
Overweight
Keywords: Holiday Season
Prevention
Lead sponsor: Universidad de Sonora
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

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

Primary outcomes:
measure: Changes in body weight
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Changes in body mass index
timeFrame: Baseline to 8 weeks
measure: Changes in waist circumference
timeFrame: Baseline to 8 weeks
measure: Changes in kilograms of body fat
timeFrame: Baseline to 8 weeks
measure: Changes in body fat index
timeFrame: Baseline to 8 weeks
measure: Changes in cm2 of abdominal fat
timeFrame: Baseline to 8 weeks
measure: Changes in systolic blood pressure
timeFrame: Baseline to 8 weeks
measure: Changes in diastolic blood pressure
timeFrame: Baseline to 8 weeks
measure: Changes in perception of health related quality of life
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Promoción de Salud Nutricional (CPSN)
state: Sonora
Study officials:
References: