OverweightNCT03599817
Program of Healthy Lifestyle Promotion in Yaqui Indigenous in Sonora
A study testing Healthy lifestyle promotion program in people with Overweight and Obesity, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 4 sites in Mexico.
Trial summary
Obesity has become an epidemic worldwide and is considered one of the main causes related to type 2 diabetes. The World Health Organization reported that in 2016, 39% of adults were overweight, while the percentage of obesity was 13%, together 1900 million people were overweight/obese. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Healthy lifestyle promotion program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesMexico
- Study dates
- 24 Jul 2018to Mar 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women being of the Yaqui tribe
- Age 20 years and less than 65
- Overweight or obese (BMI ≥25 kg/m2)
- FINDRISC score of 12 or higher
- Sign up the consent form and wish to participate
Who cannot join
- Subjects with diagnosis previous of diabetes
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg)
- Renal insufficiency
- Hepatopathies
- Neoplasms
- Inflammatory and traumatic rheumatoid arthritis
Show all 21Show fewer
- Cardiovascular disease
- Chronic obstructive pulmonary disease
- Thyroid disease
- Systemic lupus erythematosus
- Inflammatory bowel disease
- HIV
- Psoriasis
- Mesangial proliferative glomerulonephritis
- Seriously ill
- Bacterial and viral infections at the time of taking the blood sample
- Pregnant women and/or stage of lactation
- Subjects with limitations to carry out physical exercise
- Subjects that have participated in another similar program
- Subjects in pharmacological treatment for obesity
- People under pharmacological treatment that alter glucose tolerance and lipid levels
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites
Dispensario médico
Ciudad Obregón, Loma de Guamúchil
Dispensario médico
Guaymas, Pótam
Dispensario médico
Guaymas, Tórim
Dispensario médico
Guaymas, Vícam
About this study
Official title: Healthy Lifestyle Promotion Program as a Strategy to Improve Obesity Parameters, Cardiovascular and Metabolic Risk Factors in Yaquis Indigenous in the State of Sonora
Obesity has become an epidemic worldwide and is considered one of the main causes related to type 2 diabetes. The World Health Organization reported that in 2016, 39% of adults were overweight, while the percentage of obesity was 13%, together 1900 million people were overweight/obese. While in 2014 it was reported that 8.5% of the population in the world suffered from type 2 diabetes. On the other hand, in the national context, the last report of 2016 that 72.5% of the Mexican population suffers from overweight/obesity. In addition, in 2006, 14.4% of Mexicans suffered from type 2 diabetes.
Obesity is a complex chronic state that is developed by an imbalance between the energy ingested and the energy expended. In addition, obesity is considered a chronic inflammatory state of low degree of cause of the immune response generated, as a consequence of the increase of adipose tissue; what explains the imbalance in the markers of inflammation. This inflammation condition has been related to the generation of insulin resistance, the increase in glucose levels and the appearance of various pathologies such as type 2 diabetes and other risk factors for cardiovascular diseases.
Read more
The Yaqui ethnic group is located in the center-south zone of the state of Sonora, distributed in 8 traditional villages. A recent study conducted in the Yaqui community reported a prevalence of overweight and obesity of 25% and 43% respectively. In 2008, a prevalence of type 2 diabetes of 18.3% was reported in its inhabitants.
On the other hand, there are successful programs in reducing body weight through interventions aimed at modifying lifestyles such as eating habits and physical function called Lifestyle Modification Programs. These programs have been supported through controlled and randomized clinical trials. Such is the case of the Diabetes Prevention Program. Which has achieved weight reduction and increased physical activity in the subjects treated. The Diabetes Prevention Program has been recognized and adapted for the Centers for Disease Control and Prevention and has been dubbed the "National Diabetes Prevention Program".
The present study is a translational research clinical trial to evaluate the effectiveness of a program to promote the parameters of obesity and diabetes in the cardiovascular communities in the Yaqui community of the state of Sonora.
Read the detailed description
The study focuses on knowing if the program of promotion of healthy lifestyle can reduce the risk of developing type 2 diabetes in adults of the Yaqui ethnic group with overweight / obesity and with risk of diabetes of the state of Sonora, through the loss of body weight and the promotion of physical activity, in this way to improve obesity parameters and cardiovascular and metabolic risk factors.
The primary hypothesis is that the implementation of a program promoting the healthy lifestyle aimed at adults of the Yaqui ethnic group of Sonora with a diagnosis of overweight or obesity and a Finnish Diabetes Risk Score (FINDRISC) ≥12 will significantly improve in the medium term (12 months) the body weight, triglycerides, fasting glucose and interleukin-6 (IL-6).
The secondary hypotheses will be as follows: the implementation of a program to promote a healthy lifestyle aimed at adults of the Yaqui ethnic group of Sonora with a diagnosis of overweight or obesity, and FINDRISC score ≥12 will improve significantly in the short term (6 months) obesity parameters, blood glucose levels, insulin, lipid profile, blood pressure and physical activity.
The implementation of a healthy lifestyle promotion program aimed at adults of the Sonoran Yaqui ethnic group with a diagnosis of overweight or obesity and a FINDRISC score ≥12 will significantly improve medium-term (12 months) obesity parameters, blood levels of insulin, lipid profile, inflammation markers, blood pressure and physical activity.
The implementation of a healthy lifestyle promotion program aimed at adults of the Sonoran Yaqui ethnic group with a diagnosis of overweight or obesity and a FINDRISC score ≥12 will significantly improve long-term (18 months) obesity parameters, blood levels, lipid profile, blood pressure and physical activity.
.
- Conditions
- Overweight, Obesity
- Being tested
- Healthy lifestyle promotion program
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle promotion programBehavioural
Before implementing the healthy lifestyle program, it will be adapted according to the characteristics of the Yaqui community, their type of food and the activities they carry out, so that the intervention program is culturally accepted by the community. The intervention will consist of two stages, an intensive phase and a maintenance phase. In the intensive phase, 16 weekly group sessions will be given with the aim of achieving a 5% body weight loss and ensuring that the participants do at least 150 minutes of physical activity per week. In the maintenance phase, 6 monthly group sessions will be given in order to maintain the results achieved in the first stage. In the same maintenance phase, but from 12 to 18 months, the lifestyle trainers will make home visits to the participants. Lifestile trainers will record body weight, physical activity and food consumption. In this period there will be no sessions, only monthly visits.
| Study group | Role | What they receive |
|---|---|---|
| Healthy lifestyle promotion program | Experimental | All the participants of the intervention program will be offered group sessions focused on healthy eating, promotion of physical activity and behavioral changes. In this way, the loss of body weight and the increase of physical activity will be promoted. Translating into an improvement in obesity parameters and cardiovascular and metabolic risk factors, to reduce the risk of developing type 2 diabetes. Receives: Behavioral: Healthy lifestyle promotion program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Change in body weight
Measured: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
Triglycerides (mg/dL)
Change in triglycerides
Measured: Change in triglycerides from baseline to 6 months and change in triglycerides baseline to 12 months
Fasting glucose (mg/dL)
Change in fasting glucose
Measured: Change in fasting glucose from baseline to 6 months and change in fasting glucose from baseline to 12 months
IL-6 (pg/ml)
Change in IL-6
Measured: Change in IL-6 from baseline to 12 months
Secondary outcomes (21)
Body Mass Index (kg/m2)
Change in Body Mass Index
Measured: Change in Body Mass Index from baseline to 6 months and change in Body Mass Index from baseline to 12 months
Waist circumference (cm)
Change in waist circumference
Measured: Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
Body fat percentage (%)
Change in body fat percentage
Measured: Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
Fasting insulin (mg/dL)
Change in fasting insulin
Measured: Change in fasting insulin from baseline to 6 months and change in fasting insulin from baseline to 12 months
Total cholesterol (mg/dL)
Change in total cholesterol
Measured: Change in total cholesterol from baseline to 6 months and change in total cholesterol from baseline to 12 months
LDL-cholesterol (mg/dL)
Change in LDL-cholesterol
Measured: Change in LDL-cholesterol from baseline to 6 months and change in LDL-cholesterol from baseline to 12 months
HDL-cholesterol (mg/dL)
Change in HDL-cholesterol
Measured: Change in HDL-cholesterol from baseline to 6 months and change in HDL-cholesterol from baseline to 12 months
Systolic and diastolic blood pressure (mmHg)
Change in systolic and diastolic blood pressure
Measured: Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
Physical activity (minutes/week)
Change in physical activity
Measured: Change in physical activity from baseline to 6 months and change in physical activity from baseline to 12 months
Tumor Necrosis Factor-α (TNF-α) (pg/ml)
Change in TNF-α
Measured: Change in TNF-α from baseline to 12 months
Adiponectin (µg/ml)
Change in adiponectin
Measured: Change in adiponectin from baseline to 12 months
Body weight (kg)
Change in body weight
Measured: Change in body weight from 6 months to 12 and 18 months
Body Mass Index (kg/m2)
Change in body mass index
Measured: Change in body mass index from 6 months to 12 and 18 months
Waist circumference (cm)
Change in waist circumference
Measured: Change in waist circumference from 6 months to 12 and 18 months
Body fat percentage (%)
Change in body fat percentage
Measured: Change in waist circumference from 6 months to 12 and 18 months
Fasting glucose (mg/dL)
Change in fasting glucose
Measured: Change in fasting glucose from 6 months to 12 and 18 months
Total cholesterol (mg/dL)
Change in total cholesterol
Measured: Change in total cholesterol from 6 months to 12 and 18 months
LDL-cholesterol (mg/dL)
Change in LDL-cholesterol
Measured: Change in LDL-cholesterol from 6 months to 12 and 18 months
HDL-cholesterol (mg/dL)
Change in HDL-cholesterol
Measured: Change in HDL-cholesterol from 6 months to 12 and 18 months
Systolic and diastolic blood pressure (mmHg)
Change in systolic and diastolic blood pressure
Measured: Change in systolic and diastolic blood pressure from 6 months to 12 and 18 months
Physical activity (minutes/week)
Change in physical activity
Measured: Change in physical activity from 6 months to 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start24 Jul 2018
- Primary completion20 Feb 2020
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julián Esparza-Romero, Ph.D, Principal investigator, Centro de Investigación en Alimentación y Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599817
- Sponsor's protocol ID
- JER002
- Status last verified
- Jan 2020
- First submitted
- 16 Jul 2018
- Last updated
- 26 Jan 2021
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Lifestyle Promotion Program as a Strategy to Improve Obesity Parameters, Cardiovascular and Metabolic Risk Factors in Yaquis Indigenous in the State of Sonora
- ClinicalTrials.gov ID
- NCT03599817
- Acronym / sponsor ID
- JER002
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.University, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 26 Jul 2018 (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 has become an epidemic worldwide and is considered one of the main causes related to type 2 diabetes. The World Health Organization reported that in 2016, 39% of adults were overweight, while the percentage of obesity was 13%, together 1900 million people were overweight/obese. While in 2014 it was reported that 8.5% of the population in the world suffered from type 2 diabetes. On the other hand, in the national context, the last report of 2016 that 72.5% of the Mexican population suffers from overweight/obesity. In addition, in 2006, 14.4% of Mexicans suffered from type 2 diabetes.
Obesity is a complex chronic state that is developed by an imbalance between the energy ingested and the energy expended. In addition, obesity is considered a chronic inflammatory state of low degree of cause of the immune response generated, as a consequence of the increase of adipose tissue; what explains the imbalance in the markers of inflammation. This inflammation condition has been related to the generation of insulin resistance, the increase in glucose levels and the appearance of various pathologies such as type 2 diabetes and other risk factors for cardiovascular diseases.
The Yaqui ethnic group is located in the center-south zone of the state of Sonora, distributed in 8 traditional villages. A recent study conducted in the Yaqui community reported a prevalence of overweight and obesity of 25% and 43% respectively. In 2008, a prevalence of type 2 diabetes of 18.3% was reported in its inhabitants.
On the other hand, there are successful programs in reducing body weight through interventions aimed at modifying lifestyles such as eating habits and physical function called Lifestyle Modification Programs. These programs have been supported through controlled and randomized clinical trials. Such is the case of the Diabetes Prevention Program. Which has achieved weight reduction and increased physical activity in the subjects treated. The Diabetes Prevention Program has been recognized and adapted for the Centers for Disease Control and Prevention and has been dubbed the "National Diabetes Prevention Program".
The present study is a translational research clinical trial to evaluate the effectiveness of a program to promote the parameters of obesity and diabetes in the cardiovascular communities in the Yaqui community of the state of Sonora.
Detailed description
The study focuses on knowing if the program of promotion of healthy lifestyle can reduce the risk of developing type 2 diabetes in adults of the Yaqui ethnic group with overweight / obesity and with risk of diabetes of the state of Sonora, through the loss of body weight and the promotion of physical activity, in this way to improve obesity parameters and cardiovascular and metabolic risk factors.
The primary hypothesis is that the implementation of a program promoting the healthy lifestyle aimed at adults of the Yaqui ethnic group of Sonora with a diagnosis of overweight or obesity and a Finnish Diabetes Risk Score (FINDRISC) ≥12 will significantly improve in the medium term (12 months) the body weight, triglycerides, fasting glucose and interleukin-6 (IL-6).
The secondary hypotheses will be as follows: the implementation of a program to promote a healthy lifestyle aimed at adults of the Yaqui ethnic group of Sonora with a diagnosis of overweight or obesity, and FINDRISC score ≥12 will improve significantly in the short term (6 months) obesity parameters, blood glucose levels, insulin, lipid profile, blood pressure and physical activity.
The implementation of a healthy lifestyle promotion program aimed at adults of the Sonoran Yaqui ethnic group with a diagnosis of overweight or obesity and a FINDRISC score ≥12 will significantly improve medium-term (12 months) obesity parameters, blood levels of insulin, lipid profile, inflammation markers, blood pressure and physical activity.
The implementation of a healthy lifestyle promotion program aimed at adults of the Sonoran Yaqui ethnic group with a diagnosis of overweight or obesity and a FINDRISC score ≥12 will significantly improve long-term (18 months) obesity parameters, blood levels, lipid profile, blood pressure and physical activity.
.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy lifestyle promotion program | Experimental | Behavioral: Healthy lifestyle promotion programAll the participants of the intervention program will be offered group sessions focused on healthy eating, promotion of physical activity and behavioral changes. In this way, the loss of body weight and the increase of physical activity will be promoted. Translating into an improvement in obesity parameters and cardiovascular and metabolic risk factors, to reduce the risk of developing type 2 diabetes. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women being of the Yaqui tribe
- Age 20 years and less than 65
- Overweight or obese (BMI ≥25 kg/m2)
- FINDRISC score of 12 or higher
- Sign up the consent form and wish to participate
Key exclusion criteria (21 listed)
- Subjects with diagnosis previous of diabetes
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg)
- Renal insufficiency
- Hepatopathies
- Neoplasms
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 |
|---|---|---|
| Healthy lifestyle promotion programBefore implementing the healthy lifestyle program, it will be adapted according to the characteristics of the Yaqui community, their type of food and the activities they carry out, so that the intervention program is culturally accepted by the community. The intervention will consist of two stages, an intensive phase and a maintenance phase. In the intensive phase, 16 weekly group sessions will be given with the aim of achieving a 5% body weight loss and ensuring that the participants do at least 150 minutes of physical activity per week. In the maintenance phase, 6 monthly group sessions will be given in order to maintain the results achieved in the first stage. In the same maintenance phase, but from 12 to 18 months, the lifestyle trainers will make home visits to the participants. Lifestile trainers will record body weight, physical activity and food consumption. In this period there will be no sessions, only monthly visits. | Behavioural | Healthy lifestyle promotion program |
Primary outcome
Body weight (kg)
Time frame: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
Change in body weight
Triglycerides (mg/dL)
Time frame: Change in triglycerides from baseline to 6 months and change in triglycerides baseline to 12 months
Change in triglycerides
Fasting glucose (mg/dL)
Time frame: Change in fasting glucose from baseline to 6 months and change in fasting glucose from baseline to 12 months
Change in fasting glucose
IL-6 (pg/ml)
Time frame: Change in IL-6 from baseline to 12 months
Change in IL-6
21 secondary outcomes
Body Mass Index (kg/m2)
Time frame: Change in Body Mass Index from baseline to 6 months and change in Body Mass Index from baseline to 12 months
Waist circumference (cm)
Time frame: Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
Body fat percentage (%)
Time frame: Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
Fasting insulin (mg/dL)
Time frame: Change in fasting insulin from baseline to 6 months and change in fasting insulin from baseline to 12 months
Total cholesterol (mg/dL)
Time frame: Change in total cholesterol from baseline to 6 months and change in total cholesterol from baseline to 12 months
LDL-cholesterol (mg/dL)
Time frame: Change in LDL-cholesterol from baseline to 6 months and change in LDL-cholesterol from baseline to 12 months
HDL-cholesterol (mg/dL)
Time frame: Change in HDL-cholesterol from baseline to 6 months and change in HDL-cholesterol from baseline to 12 months
Systolic and diastolic blood pressure (mmHg)
Time frame: Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
Physical activity (minutes/week)
Time frame: Change in physical activity from baseline to 6 months and change in physical activity from baseline to 12 months
Tumor Necrosis Factor-α (TNF-α) (pg/ml)
Time frame: Change in TNF-α from baseline to 12 months
Adiponectin (µg/ml)
Time frame: Change in adiponectin from baseline to 12 months
Body weight (kg)
Time frame: Change in body weight from 6 months to 12 and 18 months
Body Mass Index (kg/m2)
Time frame: Change in body mass index from 6 months to 12 and 18 months
Waist circumference (cm)
Time frame: Change in waist circumference from 6 months to 12 and 18 months
Body fat percentage (%)
Time frame: Change in waist circumference from 6 months to 12 and 18 months
Fasting glucose (mg/dL)
Time frame: Change in fasting glucose from 6 months to 12 and 18 months
Total cholesterol (mg/dL)
Time frame: Change in total cholesterol from 6 months to 12 and 18 months
LDL-cholesterol (mg/dL)
Time frame: Change in LDL-cholesterol from 6 months to 12 and 18 months
HDL-cholesterol (mg/dL)
Time frame: Change in HDL-cholesterol from 6 months to 12 and 18 months
Systolic and diastolic blood pressure (mmHg)
Time frame: Change in systolic and diastolic blood pressure from 6 months to 12 and 18 months
Physical activity (minutes/week)
Time frame: Change in physical activity from 6 months to 12 and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- 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.
Julián Esparza-Romero, Ph.D principal investigator
Centro de Investigación en Alimentación y Desarrollo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy lifestyle promotion program in people with Overweight and Obesity, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 4 sites 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 21 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
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?
Body weight (kg) (time frame: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months). The study lists 4 primary outcomes in all. 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 26 Jan 2021.