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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Spain1 site
  • Human Nutrition Unit

    Reus, Tarragona, 43201

Other trials in Spain

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.

  1. Overweight or obesity

    Prevalence of overweight and/or obesity

    Measured: Baseline

  2. 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.

  1. First posted5 Mar 2020
  2. Study start13 Jan 2020
  3. Primary completion29 May 2020
  4. Study completion8 Dec 2021

Resources

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)
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

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.

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