Iron Deficiency,Obe-MaghrebNCT01844349
Nutritional Transition in the Maghreb and Prevention of Obesity and Non-communicable Diseases
An observational study of Iron Deficiency, and Anaemia,, run by Agnes GARTNER at 2 sites in 2 countries.
Trial summary
Problematic and state of the art Obesity and its associated non communicable diseases (NCDs) are rising rapidly in middle income countries, such as those in the Maghreb (North Africa). Read more about this study
- Who is it for?
- Ages 6 months to 49 years
- Conditions the study is for
- Iron Deficiency,, Anaemia,, Overweight,
- How many people
- 8,218 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2009to May 2010
- 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 6 months to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Residents of the region of the capital city
Who may be able to join
- To live in the region of the capital city
- To give free informed consent
Who cannot join
- Pregnancy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Morocco1 site
Faculty of Sciences, Ibn Tofaïl University
Kenitra, Rabat-Salé, 14000
Tunisia1 site
National Institute of Nutrition and Food Technology (INNTA)
Tunis, Great Tunis, 1007
About this study
Official title: Understanding the Nutritional Transition in the Maghreb to Contribute to the Prevention of Obesity and Non-communicable Diseases
Problematic and state of the art Obesity and its associated non communicable diseases (NCDs) are rising rapidly in middle income countries, such as those in the Maghreb (North Africa). This progression is related to the context of a nutrition transition (changing food and physical activity environment) and profound changes in technological advances and in society. These societies and their health systems are insufficiently prepared for this evolution, which has enormous health and socioeconomic consequences. In the context of limited resources, the priority has been given on an international level to prevention. But several problems arise: - these countries are still confronted by undernutrition in terms of micronutrient deficiencies, which coexist with obesity and NCDs, including at a family level and also individual level. Known as the 'double burden', this coexistence is relatively new and has been rarely documented until recently. Educational measures could be ineffective in a society where cultural norms do not recognise obesity and where changes in lifestyle are possibly not seen as acceptable. As well as information about citizen's knowledge of risk factors, data on their perceptions and attitudes are indispensable. Policies that involve changing the 'obesogenic' environment that individuals occupy is a priority.
Objectives of the project Overall aim: to contribute to the development of preventive strategies for obesity and chronic NCDs in the context of a nutrition transition.
Specific objectives: characterise the nature and size of the double burden (obesity/undernutrition) in regions, families and individuals; estimate the prevalence of biological and behavioural risk factors; characterise the psycho-sociocultural determinants of behaviour.
- Conditions
- Iron Deficiency,, Anaemia,, Overweight,, Metabolic Syndrome
- Keywords
- North Africa, Urban women, Double burden of malnutrition, Iron depletion, Overweight/obesity, Metabolic syndrome, Abdominal obesity, Excess body fat
- Medical subject headings
- Iron Deficiencies, Anemia, Overweight, Metabolic Syndrome, Obesity, Obesity, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index in kg/m²
Measured: baseline
Secondary outcomes (1)
Serum ferritin in µg/L
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMar 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency,Studies 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
- Time perspective
- Cross-sectional
- Enrolment
- 8,218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agnes GARTNER
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Agnes GARTNER, Institute of Research for Development, France
- Investigators
- Agnes Gartner, PhD, Principal investigator, Institute of Research for Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844349
- Sponsor's protocol ID
- Corus 6028-2
- Acronym
- Obe-Maghreb
- Status last verified
- May 2013
- First submitted
- 29 Apr 2013
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ben Cherifa F, El Ati J, Doggui R, El Ati-Hellal M, Traissac P. Prevalence of High HDL Cholesterol and Its Associated Factors Among Tunisian Women of Childbearing Age: A Cross-Sectional Study. Int J Environ Res Public Health. 2021 May 20;18(10):5461. doi: 10.3390/ijerph18105461.
PubMed 34065252Sassi S, Abassi MM, Traissac P, Ben Gharbia H, Gartner A, Delpeuch F, El Ati J. Intra-household double burden of malnutrition in a North African nutrition transition context: magnitude and associated factors of child anaemia with mother excess adiposity. Public Health Nutr. 2019 Jan;22(1):44-54. doi: 10.1017/S1368980018002495. Epub 2018 Oct 9.
PubMed 30298796Traissac P, El Ati J, Gartner A, Ben Gharbia H, Delpeuch F. Gender inequalities in excess adiposity and anaemia combine in a large double burden of malnutrition gap detrimental to women in an urban area in North Africa. Public Health Nutr. 2016 Jun;19(8):1428-37. doi: 10.1017/S1368980016000689. Epub 2016 Apr 6.
PubMed 27049694Gartner A, El Ati J, Traissac P, Bour A, Berger J, Landais E, El Hsaini H, Ben Rayana C, Delpeuch F. A double burden of overall or central adiposity and anemia or iron deficiency is prevalent but with little socioeconomic patterning among Moroccan and Tunisian urban women. J Nutr. 2014 Jan;144(1):87-97. doi: 10.3945/jn.113.178285. Epub 2013 Nov 6.
PubMed 24198310Gartner A, Berger J, Bour A, El Ati J, Traissac P, Landais E, El Kabbaj S, Delpeuch F. Assessment of iron deficiency in the context of the obesity epidemic: importance of correcting serum ferritin concentrations for inflammation. Am J Clin Nutr. 2013 Sep;98(3):821-6. doi: 10.3945/ajcn.112.054551. Epub 2013 Jul 24.
PubMed 23885047
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Nutritional Transition in the Maghreb to Contribute to the Prevention of Obesity and Non-communicable Diseases
- ClinicalTrials.gov ID
- NCT01844349
- Acronym / sponsor ID
- Obe-Maghreb / Corus 6028-2
- Conditions
- Iron Deficiency,, Anaemia,, Overweight,, Metabolic Syndrome
- Keywords
- North Africa, Urban women, Double burden of malnutrition, Iron depletion, Overweight/obesity, Metabolic syndrome, Abdominal obesity, Excess body fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,218 participants (actual)
- Lead sponsor
- Agnes GARTNEROther government
- Study start
- Mar 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 May 2013 (estimated)
- 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.
Problematic and state of the art Obesity and its associated non communicable diseases (NCDs) are rising rapidly in middle income countries, such as those in the Maghreb (North Africa). This progression is related to the context of a nutrition transition (changing food and physical activity environment) and profound changes in technological advances and in society. These societies and their health systems are insufficiently prepared for this evolution, which has enormous health and socioeconomic consequences. In the context of limited resources, the priority has been given on an international level to prevention. But several problems arise: - these countries are still confronted by undernutrition in terms of micronutrient deficiencies, which coexist with obesity and NCDs, including at a family level and also individual level. Known as the 'double burden', this coexistence is relatively new and has been rarely documented until recently. Educational measures could be ineffective in a society where cultural norms do not recognise obesity and where changes in lifestyle are possibly not seen as acceptable. As well as information about citizen's knowledge of risk factors, data on their perceptions and attitudes are indispensable. Policies that involve changing the 'obesogenic' environment that individuals occupy is a priority.
Objectives of the project Overall aim: to contribute to the development of preventive strategies for obesity and chronic NCDs in the context of a nutrition transition.
Specific objectives: characterise the nature and size of the double burden (obesity/undernutrition) in regions, families and individuals; estimate the prevalence of biological and behavioural risk factors; characterise the psycho-sociocultural determinants of behaviour.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Residents of the region of the capital city
Key inclusion criteria (2 listed)
- To live in the region of the capital city
- To give free informed consent
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body mass index in kg/m²
Time frame: baseline
1 secondary outcome
Serum ferritin in µg/L
Time frame: baseline
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 7 May 2013.
- Derived from this study: PubMed 34065252Ben Cherifa F, El Ati J, Doggui R, El Ati-Hellal M, Traissac P. Prevalence of High HDL Cholesterol and Its Associated Factors Among Tunisian Women of Childbearing Age: A Cross-Sectional Study. Int J Environ Res Public Health. 2021 May 20;18(10):5461. doi: 10.3390/ijerph18105461.
- Derived from this study: PubMed 30298796Sassi S, Abassi MM, Traissac P, Ben Gharbia H, Gartner A, Delpeuch F, El Ati J. Intra-household double burden of malnutrition in a North African nutrition transition context: magnitude and associated factors of child anaemia with mother excess adiposity. Public Health Nutr. 2019 Jan;22(1):44-54. doi: 10.1017/S1368980018002495. Epub 2018 Oct 9.
- Derived from this study: PubMed 27049694Traissac P, El Ati J, Gartner A, Ben Gharbia H, Delpeuch F. Gender inequalities in excess adiposity and anaemia combine in a large double burden of malnutrition gap detrimental to women in an urban area in North Africa. Public Health Nutr. 2016 Jun;19(8):1428-37. doi: 10.1017/S1368980016000689. Epub 2016 Apr 6.
- Derived from this study: PubMed 24198310Gartner A, El Ati J, Traissac P, Bour A, Berger J, Landais E, El Hsaini H, Ben Rayana C, Delpeuch F. A double burden of overall or central adiposity and anemia or iron deficiency is prevalent but with little socioeconomic patterning among Moroccan and Tunisian urban women. J Nutr. 2014 Jan;144(1):87-97. doi: 10.3945/jn.113.178285. Epub 2013 Nov 6.
- Derived from this study: PubMed 23885047Gartner A, Berger J, Bour A, El Ati J, Traissac P, Landais E, El Kabbaj S, Delpeuch F. Assessment of iron deficiency in the context of the obesity epidemic: importance of correcting serum ferritin concentrations for inflammation. Am J Clin Nutr. 2013 Sep;98(3):821-6. doi: 10.3945/ajcn.112.054551. Epub 2013 Jul 24.
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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.
Agnes Gartner, PhD principal investigator
Institute of Research for Development
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency, and Anaemia,, run by Agnes GARTNER at 2 sites in 2 countries.
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 2 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 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Morocco, Tunisia. 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?
Body mass index in kg/m² (time frame: baseline). 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 NCT01844349, which also lists 5 linked publications.
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 7 May 2013.