Evaluation of the Efficacy of the Watch Your Weight During Holidays Program for the Prevention of Body Weight Gain in Mexican Adults.
Primary Purpose
Obesity, Weight Gain, Overweight
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Watch your Weight During Holidays
Control Group (minimal intervention)
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Holiday Season, Prevention
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
Sites / Locations
- Centro de Promoción de Salud Nutricional (CPSN)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Watch your Weight During Holidays Program
Control group (minimal intervention)
Arm Description
Outcomes
Primary Outcome Measures
Changes in body weight
Secondary Outcome Measures
Changes in body mass index
Changes in waist circumference
Changes in kilograms of body fat
Changes in body fat index
Changes in cm2 of abdominal fat
Changes in systolic blood pressure
Changes in diastolic blood pressure
Changes in perception of health related quality of life
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.
Full Information
NCT ID
NCT05580926
First Posted
October 11, 2022
Last Updated
October 14, 2022
Sponsor
Rolando Giovanni Díaz Zavala
1. Study Identification
Unique Protocol Identification Number
NCT05580926
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Anticipated)
Primary Completion Date
January 13, 2023 (Anticipated)
Study Completion Date
January 13, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rolando Giovanni Díaz Zavala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Gain, Overweight
Keywords
Holiday Season, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Watch your Weight During Holidays Program
Arm Type
Experimental
Arm Title
Control group (minimal intervention)
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Watch your Weight During Holidays
Intervention Description
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
Other
Intervention Name(s)
Control Group (minimal intervention)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in body weight
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Changes in body mass index
Time Frame
Baseline to 8 weeks
Title
Changes in waist circumference
Time Frame
Baseline to 8 weeks
Title
Changes in kilograms of body fat
Time Frame
Baseline to 8 weeks
Title
Changes in body fat index
Time Frame
Baseline to 8 weeks
Title
Changes in cm2 of abdominal fat
Time Frame
Baseline to 8 weeks
Title
Changes in systolic blood pressure
Time Frame
Baseline to 8 weeks
Title
Changes in diastolic blood pressure
Time Frame
Baseline to 8 weeks
Title
Changes in perception of health related quality of life
Description
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.
Time Frame
Baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rolando G Díaz Zavala, Ph.D.
Phone
(52)6622893793
Ext
4632
Email
giovanni.diaz@unison.mx
Facility Information:
Facility Name
Centro de Promoción de Salud Nutricional (CPSN)
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolando G Díaz-Zavala, Ph.D.
Phone
6622893793
Ext
4632
Email
giovanni.diaz@unison.mx
First Name & Middle Initial & Last Name & Degree
Rolando G Díaz-Zavala, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Efficacy of the Watch Your Weight During Holidays Program for the Prevention of Body Weight Gain in Mexican Adults.
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