ObesityNCT05580926
Evaluation of the Efficacy of the Watch Your Weight During Holidays Program for the Prevention of Body Weight Gain in Mexican Adults.
A study testing Watch your Weight During Holidays in people with Obesity and Weight Gain, run by Rolando Giovanni Díaz Zavala at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Gain, Overweight
- What is being tested?
- Watch your Weight During Holidays
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteMexico
- Study dates
- 11 Oct 2022to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro de Promoción de Salud Nutricional (CPSN)
Hermosillo, Sonora, 83000
Rolando G Díaz-Zavala, Ph.D., 6622893793 ext. 4632, giovanni.diaz@unison.mx
Rolando G Díaz-Zavala, Ph.D.
About this study
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.
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
- Being tested
- Watch your Weight During Holidays, Control Group (minimal intervention)
- Keywords
- Holiday Season, Prevention
- Medical subject headings
- Obesity, Weight Gain, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watch your Weight During HolidaysBehavioural
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)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).
| Study group | Role | What they receive |
|---|---|---|
| Watch your Weight During Holidays Program | Experimental | Not described Receives: Behavioral: Watch your Weight During Holidays |
| Control group (minimal intervention) | Placebo comparator | Not described Receives: Other: Control Group (minimal intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Measured: Baseline to 8 weeks
Secondary outcomes (8)
Changes in body mass index
Measured: Baseline to 8 weeks
Changes in waist circumference
Measured: Baseline to 8 weeks
Changes in kilograms of body fat
Measured: Baseline to 8 weeks
Changes in body fat index
Measured: Baseline to 8 weeks
Changes in cm2 of abdominal fat
Measured: Baseline to 8 weeks
Changes in systolic blood pressure
Measured: Baseline to 8 weeks
Changes in diastolic blood pressure
Measured: Baseline to 8 weeks
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.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start11 Oct 2022 (estimated)
- Primary completion13 Jan 2023 (estimated)
- Study completion13 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rolando Giovanni Díaz Zavala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rolando Giovanni Díaz Zavala, Universidad de Sonora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580926
- Sponsor's protocol ID
- USO313008171
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05580926
- Acronym / sponsor ID
- USO313008171
- Conditions
- Obesity, Weight Gain, Overweight
- Keywords
- Holiday Season, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Rolando Giovanni Díaz ZavalaUniversity, hospital or other
- Study start
- 11 Oct 2022 (estimated)
- Primary completion
- 13 Jan 2023 (estimated)
- Study completion
- 13 Jan 2023 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Watch your Weight During Holidays Program | Experimental | Behavioral: Watch your Weight During Holidays |
| Control group (minimal intervention) | Placebo comparator | Other: Control Group (minimal intervention) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watch your Weight During HolidaysParticipants 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. | Behavioural | Watch your Weight During Holidays Program |
| 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). | Other | Control group (minimal intervention) |
Primary outcome
Changes in body weight
Time frame: Baseline to 8 weeks
8 secondary outcomes
Changes in body mass index
Time frame: Baseline to 8 weeks
Changes in waist circumference
Time frame: Baseline to 8 weeks
Changes in kilograms of body fat
Time frame: Baseline to 8 weeks
Changes in body fat index
Time frame: Baseline to 8 weeks
Changes in cm2 of abdominal fat
Time frame: Baseline to 8 weeks
Changes in systolic blood pressure
Time frame: Baseline to 8 weeks
Changes in diastolic blood pressure
Time frame: Baseline to 8 weeks
Changes in perception of health related quality of life
Time frame: Baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watch your Weight During Holidays in people with Obesity and Weight Gain, run by Rolando Giovanni Díaz Zavala at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolando G Díaz Zavala, Ph.D. ((52)6622893793 ext. 4632, giovanni.diaz@unison.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.