Obesity, ChildhoodNCT04297722
Dairy Consumption and Overweight and Obesity in Children and Adolescents: a Meta-analysis.
An observational study of Obesity, Childhood and Overweight, Childhood, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
According to statistics from the European Association for the Study of Obesity (EASO), taking into account the definition of overweight and obesity recommended by the International Obesity Task Fort (IOTF), the prevalence of overweight (including obesity) in European children aged 7 to 17 years is 16-22% and the… Read more about this study
- Who is it for?
- Ages 3 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Overweight, Childhood, Overweight and Obesity
- What is being tested?
- Dairy products
- How many people
- 1 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2020to 8 Dec 2021
- Phase
- Observational
- 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 3 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All children (aged 2 years old to 21 years old), regardless of health status
Who may be able to join
- Cross-sectional and Prospective cohort studies
- At least 1 year of follow-up (for prospective cohorts)
- Children and adolescents participants
- Dairy consumption (total dairy, full-fat dairy, low-fat dairy, total milk, full-fat milk, low-f fat milk, total yogurt, full-fat yogurt, low-fat yogurt, total cheese, hard cheese, fresh cheese) as exposure
- Overweight or obesity as outcomes
- Odd ratios, risk ratios or hazard ratios and their corresponding 95% confidence interval (CI) as a measure of effect estimators.
Who cannot join
- Ecological, retrospective observational studies, non-human studies, letters, comments, reports, especial articles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Associations Between Dairy Consumption and the Prevalence and Incidence of Overweight and Obesity in Children and Adolescents: a Systematic Review and Meta-analysis.
According to statistics from the European Association for the Study of Obesity (EASO), taking into account the definition of overweight and obesity recommended by the International Obesity Task Fort (IOTF), the prevalence of overweight (including obesity) in European children aged 7 to 17 years is 16-22% and the prevalence of obesity is 4-6%.
Some review studies3 and meta-analysis4,5 have reported an inverse relationship between dairy products consumption and the prevalence or incidence of overweight and obesity. However, some methodological issues arise from these analyses. For instance, the combination of studies with different exposures (e.g. full fat milk, total milk) in the total dairy product analysis. Moreover, since the publication of the lasts meta-analysis in 2016, new epidemiological studies evaluating the association between dairy product consumption and overweight or obesity risk have been published.
Objective The aim of this work is to systematically review and assess the associations between total dairy consumption and its different subtypes with the prevalence and incidence of overweight and obesity in children and adolescents.
Read the detailed description
Searches: We will search the following electronic bibliographic databases: MEDLINE (PubMed) and The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials.
The search strategy will include only terms relating to or describing the exposure. There will be no language restrictions.
Data extraction (selection and coding):
In the first step duplicate studies will be removed. Secondly, studies will be screened based on the title and abstract in order to exclude those that do not meet the inclusion criteria. In the last step, articles will be reviewed in full to select those that meet all the inclusion criteria.
Two reviewers (LL and MM) will independently extract relevant data and assess the risk of bias following a standardize proforma. Relevant data will include:
- Authors, journal and year of publication
- Title
- Study design
- Study name
- Country/location of study
- Sample size
- Characteristics of the subjects
- Follow-up duration (for prospective cohort studies)
- Health status
- Sources of funding
- Type of exposure and assessment method
- Outcome and assessment method
- Odd ratios, risk ratios or hazard ratios and 95%CI
- Statistical analyses
Risk of bias (quality) assessment:
Two review authors will independently assess the risk of bias in included studies by considering the following tools: The New-Castle Ottawa scale will be used to assessed the quality of the included prospective cohort studies, whereas the NIH National Heart, Lung and Blood Institute. Study quality assessment tools will be used for cross-sectional studies. Any disagreement will be solved by consensus or consulting with a third author (NB-T).
Strategy for data synthesis The meta-analysis will be conducted according to the Cochrane handbook for systematic reviews of interventions and results will be reported following the meta-analysis of observational studies in epidemiology (MOOSE) guidelines. The generic inverse-variance method with random-effects models or fixed-effects models, when at least 5 or less than 5 comparisons are available, respectively, will be used to obtain summary estimates. Inter-study heterogeneity will be assessed by the Cochrane Q statistics (p<0.10 will be considered significant) and quantified by the I2 statistic (≥ 50% will indicate substantial heterogeneity). Possible sources of heterogeneity will be explored by conducting sensitivity analyses, in which one study will be systematically removed at a time. If 10 or more comparisons are available, researchers will also explore sources of heterogeneity by a priori subgroup analyses (including, age, gender, geographical area and study quality). Meta-regression will assess the significance of categorical and continuous subgroup analyses. Linear and non-linear dose response relationship will be assessed by using generalized least squares trend (GLST) estimation models and spline curve modelling (MKSPLINE procedure), respectively. Publication bias will be assessed by visual inspection of funnel plots and the Egger and Begg tests when at least 10 trial comparisons are available.
Analysis of subgroups or subsets:
Prior subgroup analysis are planned to be conducted if at least 10 study comparisons are available. This will include: age (< or > of the median), gender (boys, girls and mixed), geographical area (America, Europe, Africa, Asia and Oceania), study quality (high vs low quality).
- Being tested
- Dairy products
- Keywords
- systematic review and meta-analysis, dairy products, prospective studies, cross-sectional studies
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy productsOther
Dairy consumption including total dairy, full-fat dairy, low-fat dairy, total milk, full-fat milk, low-fat milk, total yogurt, full-fat yogurt, low-fat yogurt, total cheese, hard cheese and fresh cheese
What is being measured
The primary outcome is the main question the study is designed to answer.
Overweight or obesity
Prevalence of overweight and/or obesity
Measured: Baseline
Overweight or obesity
incidence of overweight and/or obesity
Measured: Up to 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start13 Jan 2020
- Primary completion29 May 2020
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nerea Becerra Tomás, RD PhD, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- Jordi Salas-Salvadó, Professor, Study chair, Rovira i Virgili University, IISPV, CIBERobn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297722
- Sponsor's protocol ID
- Unitat_Nutrició_001
- Status last verified
- Sep 2022
- First submitted
- 2 Mar 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Babio N, Becerra-Tomas N, Nishi SK, Lopez-Gonzalez L, Paz-Graniel I, Garcia-Gavilan J, Schroder H, Martin-Calvo N, Salas-Salvado J. Total dairy consumption in relation to overweight and obesity in children and adolescents: A systematic review and meta-analysis. Obes Rev. 2022 Jan;23 Suppl 1:e13400. doi: 10.1111/obr.13400. Epub 2021 Dec 8.
PubMed 34881504
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Dairy Consumption and the Prevalence and Incidence of Overweight and Obesity in Children and Adolescents: a Systematic Review and Meta-analysis.
- ClinicalTrials.gov ID
- NCT04297722
- Acronym / sponsor ID
- Unitat_Nutrició_001
- Keywords
- systematic review and meta-analysis, dairy products, prospective studies, cross-sectional studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 5 Mar 2020 (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.
According to statistics from the European Association for the Study of Obesity (EASO), taking into account the definition of overweight and obesity recommended by the International Obesity Task Fort (IOTF), the prevalence of overweight (including obesity) in European children aged 7 to 17 years is 16-22% and the prevalence of obesity is 4-6%.
Some review studies3 and meta-analysis4,5 have reported an inverse relationship between dairy products consumption and the prevalence or incidence of overweight and obesity. However, some methodological issues arise from these analyses. For instance, the combination of studies with different exposures (e.g. full fat milk, total milk) in the total dairy product analysis. Moreover, since the publication of the lasts meta-analysis in 2016, new epidemiological studies evaluating the association between dairy product consumption and overweight or obesity risk have been published.
Objective The aim of this work is to systematically review and assess the associations between total dairy consumption and its different subtypes with the prevalence and incidence of overweight and obesity in children and adolescents.
Detailed description
Searches: We will search the following electronic bibliographic databases: MEDLINE (PubMed) and The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials.
The search strategy will include only terms relating to or describing the exposure. There will be no language restrictions.
Data extraction (selection and coding):
In the first step duplicate studies will be removed. Secondly, studies will be screened based on the title and abstract in order to exclude those that do not meet the inclusion criteria. In the last step, articles will be reviewed in full to select those that meet all the inclusion criteria.
Two reviewers (LL and MM) will independently extract relevant data and assess the risk of bias following a standardize proforma. Relevant data will include:
- Authors, journal and year of publication
- Title
- Study design
- Study name
- Country/location of study
- Sample size
- Characteristics of the subjects
- Follow-up duration (for prospective cohort studies)
- Health status
- Sources of funding
- Type of exposure and assessment method
- Outcome and assessment method
- Odd ratios, risk ratios or hazard ratios and 95%CI
- Statistical analyses
Risk of bias (quality) assessment:
Two review authors will independently assess the risk of bias in included studies by considering the following tools: The New-Castle Ottawa scale will be used to assessed the quality of the included prospective cohort studies, whereas the NIH National Heart, Lung and Blood Institute. Study quality assessment tools will be used for cross-sectional studies. Any disagreement will be solved by consensus or consulting with a third author (NB-T).
Strategy for data synthesis The meta-analysis will be conducted according to the Cochrane handbook for systematic reviews of interventions and results will be reported following the meta-analysis of observational studies in epidemiology (MOOSE) guidelines. The generic inverse-variance method with random-effects models or fixed-effects models, when at least 5 or less than 5 comparisons are available, respectively, will be used to obtain summary estimates. Inter-study heterogeneity will be assessed by the Cochrane Q statistics (p<0.10 will be considered significant) and quantified by the I2 statistic (≥ 50% will indicate substantial heterogeneity). Possible sources of heterogeneity will be explored by conducting sensitivity analyses, in which one study will be systematically removed at a time. If 10 or more comparisons are available, researchers will also explore sources of heterogeneity by a priori subgroup analyses (including, age, gender, geographical area and study quality). Meta-regression will assess the significance of categorical and continuous subgroup analyses. Linear and non-linear dose response relationship will be assessed by using generalized least squares trend (GLST) estimation models and spline curve modelling (MKSPLINE procedure), respectively. Publication bias will be assessed by visual inspection of funnel plots and the Egger and Begg tests when at least 10 trial comparisons are available.
Analysis of subgroups or subsets:
Prior subgroup analysis are planned to be conducted if at least 10 study comparisons are available. This will include: age (< or > of the median), gender (boys, girls and mixed), geographical area (America, Europe, Africa, Asia and Oceania), study quality (high vs low quality).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All children (aged 2 years old to 21 years old), regardless of health status
Key inclusion criteria (6 listed)
- Cross-sectional and Prospective cohort studies
- At least 1 year of follow-up (for prospective cohorts)
- Children and adolescents participants
- Dairy consumption (total dairy, full-fat dairy, low-fat dairy, total milk, full-fat milk, low-f fat milk, total yogurt, full-fat yogurt, low-fat yogurt, total cheese, hard cheese, fresh cheese) as exposure
- Overweight or obesity as outcomes
Key exclusion criteria (1 listed)
- Ecological, retrospective observational studies, non-human studies, letters, comments, reports, especial articles.
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 |
|---|---|---|
| Dairy productsDairy consumption including total dairy, full-fat dairy, low-fat dairy, total milk, full-fat milk, low-fat milk, total yogurt, full-fat yogurt, low-fat yogurt, total cheese, hard cheese and fresh cheese | Other | – |
Primary outcome
Overweight or obesity
Time frame: Baseline
Prevalence of overweight and/or obesity
Overweight or obesity
Time frame: Up to 40 years
incidence of overweight and/or obesity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Results publication: PubMed 34881504Babio N, Becerra-Tomas N, Nishi SK, Lopez-Gonzalez L, Paz-Graniel I, Garcia-Gavilan J, Schroder H, Martin-Calvo N, Salas-Salvado J. Total dairy consumption in relation to overweight and obesity in children and adolescents: A systematic review and meta-analysis. Obes Rev. 2022 Jan;23 Suppl 1:e13400. doi: 10.1111/obr.13400. Epub 2021 Dec 8.
- 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.
Jordi Salas-Salvadó, Professor study chair
Rovira i Virgili University, IISPV, CIBERobn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Overweight, Childhood, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 29 Sep 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overweight or obesity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297722, which also lists 1 linked publication.
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 29 Sep 2022.