Weight GainNCT05060978
Evaluation of the Effect of Two Online Interventions -Watch Your Weight During the Holidays Program and the Relative 5:2 Fasting- for the Prevention of Body Weight Gain at 8 Weeks in Mexican Adults in the Covid-19 Pandemic
A study testing Watch your Weight During the Holidays Program and Relative 5:2 Fasting in people with Weight Gain and Overweight, run by Universidad de Sonora at 1 site in Mexico.
Trial summary
Introduction. Obesity is the main risk factor for the development of chronic degenerative diseases in Mexico and other countries around the world. Due to the difficulty of treating obesity, it is necessary to change the curative paradigm for a preventive one. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Overweight, Obesity
- What is being tested?
- Watch your Weight During the Holidays Program and Relative 5:2 Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 10 Nov 2021to 11 Feb 2022
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mexican adult participants (≥20 and ≤60 years)
- Residents of the city of Hermosillo, Sonora
- Body Mass Index ≥ 23 kg/m2 and ≤ 40 kg/m2
- Availability and motivation to attend the intervention program
- Committed to not undertake any other intervention in place of, or in combination with, the one assigned in the study during the 8 weeks of the intervention
Who cannot join
- Diagnosed medical conditions that constitute a contraindication for intervention such as: diabetes, hypertension, diseases with an effect on body weight (for example: liver failure; cancer in treatment or in advanced stage; history of COVID-19 that required hospitalization, supplemental oxygen or has left sequelae that contraindicates 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.
Show all 9Show fewer
- 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
Centro de Promoción de Salud Nutricional (CPSN)
Hermosillo, Sonora, 83000
About this study
Official title: Evaluation of the Effect of Two Online Interventions -Watch Your Weight During the Holidays Program and the Relative 5:2 Fasting- for the Prevention of Body Weight Gain at 8 Weeks in Mexican Adults in the Covid-19 Pandemic: A Pilot Three Arm Parallel-Group Randomized Controlled Trial
Introduction. Obesity is the main risk factor for the development of chronic degenerative diseases in Mexico and other countries around the world. Due to the difficulty of treating obesity, it is necessary to change the curative paradigm for a preventive one. A review showed that holiday periods during the year are critical points for weight gain. The holiday season is the festive period with the greatest impact on adults' body weight. Observational studies have shown that more than 50% of the annual weight is gained during this period. However, few preventive interventions in the festive period have been carried out globally. Additionally, the COVID-19 pandemic seems to be negatively affecting diet, physical activity and body weight. So preventive interventions are needed, especially those that can be implemented in an online format. The purpose of the study is to evaluate the effect of two online interventions -Watch your Weight during the Holidays Program and the Relative 5:2 Fasting - on the prevention of body weight gain from baseline to 8 weeks in comparison with a control group in Mexican adults during the COVID-19 pandemic. Methodology: This is a Pilot Randomized Controlled Trial (RCT). The primary outcome is the change in body weight from baseline to 8 weeks. Secondary outcomes are the percentage of retention / desertion of the participants, adherence to interventions, participant satisfaction scale, changes in other obesity parameters, biochemical, physical, and quality of life variables from baseline to 8 weeks. Obesity and quality of life parameters from baseline to 52 weeks are also secondary outcomes. The statistical analysis of the primary and secondary variables will be conducted, according to their distribution, by intention to treat and, secondarily, by completer´s analysis.
- Conditions
- Weight Gain, Overweight, Obesity
- Being tested
- Watch your Weight During the Holidays Program, Relative 5:2 Fasting, Control Group
- Keywords
- Holiday Season, Normal weight, Prevention
- Medical subject headings
- Weight Gain, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watch your Weight During the Holidays ProgramBehavioural
Participants in this group will have two video call individual sessions and one video call group session. This intervention will include self-monitoring strategies (self-weighing, diet monitoring and physical activity), and nutrition counseling and education. In addition, participants in this group will receive a weighing scale to achieve self-monitoring of body weight from the beginning of the study intervention until the end of the 52-weeks follow-up.
Relative 5:2 FastingOther
Participants in this group will will have two video call individual sessions and one video call group session. This intervention will receive eating recommendations to follow a 5:2 intermittent fasting. They will be given low-calorie menus of 550 kcal and 660 kcal, for women and men respectively, which the participants in this group will apply on fasting days. The fasting will be held twice a week and on the remaining five days, the participants will not have any type of caloric restriction (it will be ad libitum). They will only have the general recommendation to adhere to a healthy dietary pattern.
Control GroupOther
Participants in this group will receive online information and a PDF file brochure during an individual video call session at the beginning of the 8-week period. This information will be about leading 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 the Holidays Program | Active comparator | Not described Receives: Behavioral: Watch your Weight During the Holidays Program |
| Relative 5:2 Fasting | Active comparator | Not described Receives: Other: Relative 5:2 Fasting |
| Control Group | Placebo comparator | Not described Receives: Other: Control Group |
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 (14)
Changes in body weight
Measured: Baseline and 52 weeks
Changes in kilograms of body fat
Measured: Baseline, 8 weeks and 52 weeks
Changes in waist circumference
Measured: Baseline, 8 weeks and 52 weeks
Changes in systolic blood pressure
Measured: Baseline, 8 weeks and 52 weeks
Changes in diastolic blood pressure
Measured: Baseline, 8 weeks and 52 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, 8 weeks and 52 weeks
Retention / desertion
The retention percentage will be obtained by dividing the number of people that finished the intervention the number that started the intervention, multiplied by 100. The dropout percentage will be obtained by the difference in the number of subjects who started and finished the intervention, multiplied by 100.
Measured: 8 weeks and 52 weeks
Adherence to intervention
Adherence to the intervention will be calculated as the percentage of study measurement appointments and group sessions attended by each participant. Another way to measure adherence to interventions will be with a numerical scale of self-evaluation from 1 to 5, where 1 is the lowest score and 5 is the highest, to indicate how adherent they were to the meal plans.
Measured: 8 weeks and 52 weeks
Participant satisfaction scale
Satisfaction of the participants in each of the intervention groups will be measured online using a scale from 1 to 5, where 1 is the lowest rating and 5 is the highest. A higher score means a higher satisfaction with the intervention recieved.
Measured: 8 weeks and 52 weeks
Changes in fasting glucose
Measured: Baseline and 8 weeks
Changes in total cholesterol
Measured: Baseline and 8 weeks
Changes in LDL cholesterol
Measured: Baseline and 8 weeks
Changes in HDL cholesterol
Measured: Baseline and 8 weeks
Changes in triglycerides
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start10 Nov 2021
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
Why it stopped: Due to the retention of 78.1% of the participants obtained for the first measurement (after the December holidays), we believe that waiting one more year to complete the study would not be feasible for a subsequent definitive study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Sonora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolando Giovanni Díaz Zavala, Universidad de Sonora
- Investigators
- Rolando G Díaz Zavala, Ph.D., Principal investigator, Universidad de Sonora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060978
- Sponsor's protocol ID
- USO313007128
- Status last verified
- May 2023
- First submitted
- 27 Sep 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Two Online Interventions -Watch Your Weight During the Holidays Program and the Relative 5:2 Fasting- for the Prevention of Body Weight Gain at 8 Weeks in Mexican Adults in the Covid-19 Pandemic: A Pilot Three Arm Parallel-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05060978
- Acronym / sponsor ID
- USO313007128
- Conditions
- Weight Gain, Overweight, Obesity
- Keywords
- Holiday Season, Normal weight, Prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the retention of 78.1% of the participants obtained for the first measurement (after the December holidays), we believe that waiting one more year to complete the study would not be feasible for a subsequent definitive study.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad de SonoraUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 29 Sep 2021 (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.
Introduction. Obesity is the main risk factor for the development of chronic degenerative diseases in Mexico and other countries around the world. Due to the difficulty of treating obesity, it is necessary to change the curative paradigm for a preventive one. A review showed that holiday periods during the year are critical points for weight gain. The holiday season is the festive period with the greatest impact on adults' body weight. Observational studies have shown that more than 50% of the annual weight is gained during this period. However, few preventive interventions in the festive period have been carried out globally. Additionally, the COVID-19 pandemic seems to be negatively affecting diet, physical activity and body weight. So preventive interventions are needed, especially those that can be implemented in an online format. The purpose of the study is to evaluate the effect of two online interventions -Watch your Weight during the Holidays Program and the Relative 5:2 Fasting - on the prevention of body weight gain from baseline to 8 weeks in comparison with a control group in Mexican adults during the COVID-19 pandemic. Methodology: This is a Pilot Randomized Controlled Trial (RCT). The primary outcome is the change in body weight from baseline to 8 weeks. Secondary outcomes are the percentage of retention / desertion of the participants, adherence to interventions, participant satisfaction scale, changes in other obesity parameters, biochemical, physical, and quality of life variables from baseline to 8 weeks. Obesity and quality of life parameters from baseline to 52 weeks are also secondary outcomes. The statistical analysis of the primary and secondary variables will be conducted, according to their distribution, by intention to treat and, secondarily, by completer´s analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Watch your Weight During the Holidays Program | Active comparator | Behavioral: Watch your Weight During the Holidays Program |
| Relative 5:2 Fasting | Active comparator | Other: Relative 5:2 Fasting |
| Control Group | Placebo comparator | Other: Control Group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Mexican adult participants (≥20 and ≤60 years)
- Residents of the city of Hermosillo, Sonora
- Body Mass Index ≥ 23 kg/m2 and ≤ 40 kg/m2
- Availability and motivation to attend the intervention program
- Committed to not undertake any other intervention in place of, or in combination with, the one assigned in the study during the 8 weeks of the intervention
Key exclusion criteria (9 listed)
- Diagnosed medical conditions that constitute a contraindication for intervention such as: diabetes, hypertension, diseases with an effect on body weight (for example: liver failure; cancer in treatment or in advanced stage; history of COVID-19 that required hospitalization, supplemental oxygen or has left sequelae that contraindicates 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.
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 the Holidays ProgramParticipants in this group will have two video call individual sessions and one video call group session. This intervention will include self-monitoring strategies (self-weighing, diet monitoring and physical activity), and nutrition counseling and education. In addition, participants in this group will receive a weighing scale to achieve self-monitoring of body weight from the beginning of the study intervention until the end of the 52-weeks follow-up. | Behavioural | Watch your Weight During the Holidays Program |
| Relative 5:2 FastingParticipants in this group will will have two video call individual sessions and one video call group session. This intervention will receive eating recommendations to follow a 5:2 intermittent fasting. They will be given low-calorie menus of 550 kcal and 660 kcal, for women and men respectively, which the participants in this group will apply on fasting days. The fasting will be held twice a week and on the remaining five days, the participants will not have any type of caloric restriction (it will be ad libitum). They will only have the general recommendation to adhere to a healthy dietary pattern. | Other | Relative 5:2 Fasting |
| Control GroupParticipants in this group will receive online information and a PDF file brochure during an individual video call session at the beginning of the 8-week period. This information will be about leading a healthy eating based on the norm for health promotion and education for healthy eating in Mexico (NOM-043-SSA2-2012). | Other | Control Group |
Primary outcome
Changes in body weight
Time frame: Baseline to 8 weeks
14 secondary outcomes
Changes in body weight
Time frame: Baseline and 52 weeks
Changes in kilograms of body fat
Time frame: Baseline, 8 weeks and 52 weeks
Changes in waist circumference
Time frame: Baseline, 8 weeks and 52 weeks
Changes in systolic blood pressure
Time frame: Baseline, 8 weeks and 52 weeks
Changes in diastolic blood pressure
Time frame: Baseline, 8 weeks and 52 weeks
Changes in perception of health related quality of life
Time frame: Baseline, 8 weeks and 52 weeks
Retention / desertion
Time frame: 8 weeks and 52 weeks
Adherence to intervention
Time frame: 8 weeks and 52 weeks
Participant satisfaction scale
Time frame: 8 weeks and 52 weeks
Changes in fasting glucose
Time frame: Baseline and 8 weeks
Changes in total cholesterol
Time frame: Baseline and 8 weeks
Changes in LDL cholesterol
Time frame: Baseline and 8 weeks
Changes in HDL cholesterol
Time frame: Baseline and 8 weeks
Changes in triglycerides
Time frame: Baseline and 8 weeks
Results and safety
The study was stopped early (reason given: Due to the retention of 78.1% of the participants obtained for the first measurement (after the December holidays), we believe that waiting one more year to complete the study would not be feasible for a subsequent definitive study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Rolando G Díaz Zavala, Ph.D. principal investigator
Universidad de Sonora
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 the Holidays Program and Relative 5:2 Fasting in people with Weight Gain and Overweight, run by Universidad de Sonora 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 May 2023. 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?
The study was stopped early (reason given: Due to the retention of 78.1% of the participants obtained for the first measurement (after the December holidays), we believe that waiting one more year to complete the study would not be feasible for a subsequent definitive study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 16 May 2023.