Dietary InterventionNCT01301768
Group Education to Improve the Iodine Nutrition in Pregnancy: Cluster Randomized Trial
A study testing Group Education in people with Dietary Intervention and Pregnancy Jail, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The purpose of this study is to assess the effectiveness of individual education versus group education about dietary habits and iodine supplementation to decrease iodine deficiency in pregnant women Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Dietary Intervention, Pregnancy Jail, Iodine Deficiency
- What is being tested?
- Group Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2008to Dec 2011
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant Women in the first trimester
- Over the age of 17
- Receive routine care in their respective health center
Who cannot join
- Pregnant women who are in the second or third trimester.
- Pregnant women with diagnostic of thyroid disease.
- Pregnant women who do not have a phone.
- Pregnant women with communication difficulties (cognitive or sensory deterioration, language barrier).
- Pregnant women who do not consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Status of Iodine in the Pregnant Population of Catalonia: a Study of Dietary Habits and Urinary Iodine
The purpose of this study is to assess the effectiveness of individual education versus group education about dietary habits and iodine supplementation to decrease iodine deficiency in pregnant women
Read the detailed description
BACKGROUND: It is a priority to achieve an adequate nutritional status of iodine during pregnancy since iodine deficiency in this population may have repercussions on the mother during both gestation and post partum as well as on the foetus, the neonate and the child at different ages. According to the WHO, iodine deficiency is the most frequent cause of mental retardation and irrreversible cerebral lesions around the world. However, few studies have been published on the nutritional status of iodine in the pregnant population within the Primary Care setting, a health care level which plays an essential role in the education and control of pregnant women.
AIMS: 1.- To know the hygiene-dietetic habits related to the intake of foods rich in iodine and smoking during pregnancy. 2.- To determine the prevalence of iodine deficiency and the factors associated with its appearance during pregnancy.
METHODS/DESIGN: We will perform a cluster randomised, controlled, multicentre trial. Randomisation unit: Primary Care Team. Study population: 898 pregnant women over the age of 17 years attending consultation to a midwife during the first trimester of pregnancy in the participating primary care centres. Outcome measures: consumption of iodine-rich foods and iodine deficiency. Points of assessment: each trimester of the gestation. Intervention: group education during the first trimester of gestation on healthy hygiene-dietetic habits and the importance of an adequate iodine nutritional status. Statistical analysis: descriptive analysis of all variables will be performed as well as multilevel logistic regression. All analyses will be done carried out on an intention to treat basis and will be fitted for potential confounding factors and variables of clinical importance.
DISCUSSION: Evidence of generalised iodine deficiency during pregnancy could lead to the promotion of interventions of prevention such as how to improve and intensify health care educational programmes for pregnant women.
- Conditions
- Dietary Intervention, Pregnancy Jail, Iodine Deficiency
- Being tested
- Group Education
- Keywords
- Dietary Intervention, Pregnancy Jail, Iodine Deficiency, Iodine Nutrition, Dietary Habits, Urinary Iodine, Pregnancy, Group Education, Cluster Randomized Trial, Primary Health Care
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group EducationOther
Also called Dietary Intervention
Group educational workshops about dietary habits in the first trimester because it is when organogenesis occurs and therefore when the iodine deficiency in the mother is an important risk in the development of the fetal central nervous system.
| Study group | Role | What they receive |
|---|---|---|
| Group Education | Experimental | Group educational workshops about dietary habits in the first trimester because it is when organogenesis occurs and therefore when the iodine deficiency in the mother is an important risk in the development of the fetal central nervous system. Receives: Other: Group Education |
| Usual care | No intervention | Women in the control group receive the usual care during the pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iodine deficiency
Urinary iodine excretion below 150 µg/l
Measured: 36 weeks of pregnancy
Iodine deficiency
Urinari iodine excretion below 150 µg/l
Measured: 24 weeks of pregnancy
Secondary outcomes (68)
Date of birth
Measured: At baseline
Smoking
Categories: yes / no
Measured: First trimester of pregnancy (14 weeks)
Iodized salt consumption
Categories: yes / no
Measured: First trimester of pregnancy (14 weeks)
Iodine supplementation consumption
Categories: yes / no
Measured: First trimester of pregnancy
Education Level
Categories: can not read or write, incomplete primary, completed primary, completed secondary and university
Measured: At baseline
Ethnicity
Measured: At baseline
Number of pregnancies finishes
Measured: At baseline
Number of premature births
Measured: At baseline
Number of abortions
Measured: At baseline
Number of live births
Measured: At baseline
Trimester of pregnancy
Categories: yes / no
Measured: First trimester of pregnancy
Glasses of milk a day (number)
Measured: First trimester of pregnancy
Yogurt per week (number)
Measured: First trimester of pregnancy
Servings of cheese per week (number)
Measured: First trimester of pregnancy
Usual preparation of vegetables
Categories: raw, fried, grilled / baked, steamed and boiled
Measured: First trimester of pregnancy
Use of water to boil vegetables
Categories: yes / no
Measured: First trimester of pregnancy
Vegetable consumption per week (number)
Measured: First trimester of pregnancy
Fish consumption per week (number)
Measured: First trimester of pregnancy
Usual preparation of fish
Categories: raw, fried, grilled / baked, steamed and boiled
Measured: First trimester of pregnancy
Canned tuna consumption per week (number)
Measured: First trimester of pregnancy
Canned sardines consumption per week (number)
Measured: First trimester of pregnancy
Meat consumption per week (number)
Measured: First trimester of pregnancy
Cold meat consumption per week (number)
Measured: First trimester of pregnancy
Eggs consumption per week (number)
Measured: First trimester or pregnancy
Fruit consumption per week (number)
Measured: First trimester of pregnancy
Nuts consumption per week (number)
Measured: First trimester of pregnancy
Potassium iodide consumption
Measured: First trimester of pregnancy
Smoking
Categories: yes / no
Measured: Second trimester of pregnancy (wk 15-wk 27 )
Smoking
Categories: yes / no
Measured: Third trimester of pregnancy (wk28-wk40)
Iodized salt consumption
Categories: yes / no
Measured: Second trimester of pregnancy
Iodized salt consumption
Categories: yes / no
Measured: Third trimester of pregnancy
Iodine supplementation consumption
Categories: yes / no
Measured: Second trimester of pregnancy
Iodine supplementation consumption
Categories: yes / no
Measured: Third trimester of pregnancy
Trimester of pregnancy
Categories: yes / no
Measured: Second trimester of pregnancy
Trimester of pregnancy
Categories: yes / no
Measured: Third trimester of pregnancy
Glasses of milk a day (number)
Measured: Second trimester of pregnancy
Glasses of milk a day (number)
Measured: Third trimester of pregnancy
Yogurt per week (number)
Measured: Second trimester of pregnancy
Yogurt per week (number)
Measured: Third trimester of pregnancy
Servings of cheese per week (number)
Measured: Second trimester of pregnancy
Servings of cheese per week (number)
Measured: Third trimester of pregnancy
Usual preparation of vegetables
Categories: raw, fried, grilled / baked, steamed and boiled
Measured: Second trimester of pregnancy
Usual preparation of vegetables
Categories: raw, fried, grilled / baked, steamed and boiled
Measured: Third trimester of pregnancy
Use of water to boil vegetables
Categories: yes / no
Measured: Second trimester of pregnancy
Use of water to boil vegetables
Categories: yes / no
Measured: Third trimester of pregnancy
Vegetable consumption per week (number)
Measured: Second trimester of pregnancy
Vegetable consumption per week (number)
Measured: Third trimester of pregnancy
Fish consumption per week (number)
Measured: Second trimester of pregnancy
Fish consumption per week (number)
Measured: Third trimester of pregnancy
Usual preparation of fish
Categories: raw, fried, grilled / baked, steamed and boiled
Measured: Second trimester of pregnancy
Usual preparation of fish
Categories: raw, fried, grilled / baked, steamed and boiled
Measured: Third trimester of pregnancy
Canned tuna consumption per week (number)
Measured: Second trimester of pregnancy
Canned tuna consumption per week (number)
Measured: Third trimester of pregnancy
Canned sardines consumption per week (number)
Measured: Second trimester of pregnancy
Canned sardines consumption per week (number)
Measured: Third trimester of pregnancy
Meat consumption per week (number)
Measured: Second trimester of pregnancy
Meat consumption per week (number)
Measured: Third trimester of pregnancy
Cold meat consumption per week (number)
Measured: Second trimester of pregnancy
Cold meat consumption per week (number)
Measured: Third trimester of pregnancy
Eggs consumption per week (number)
Measured: Second trimester or pregnancy
Eggs consumption per week (number)
Measured: Third trimester or pregnancy
Fruit consumption per week (number)
Measured: Second trimester of pregnancy
Fruit consumption per week (number)
Measured: Third trimester of pregnancy
Nuts consumption per week (number)
Measured: Second trimester of pregnancy
Nuts consumption per week (number)
Measured: Third trimester of pregnancy
Potassium iodide consumption
Measured: Second trimester of pregnancy
Potassium iodide consumption
Measured: Third trimester of pregnancy
Iodine deficiency
Urinary iodine excretion below 150 µg/l
Measured: Baseline at first trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startNov 2008
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: the intervention could not be performed. All participants received Usual clinical practice
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 Dietary InterventionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, USR Metropolitana Nord, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Maria Teresa Torres Costa, Midwife, Principal investigator, Institut Català de la Salut (ICS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301768
- Sponsor's protocol ID
- PI071265
- Status last verified
- Oct 2018
- First submitted
- 31 May 2010
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prieto G, Torres MT, Frances L, Falguera G, Vila L, Manresa JM, Casamitjana R, Barrada JR, Acera A, Guix D, Torrent A, Grau J, Toran P; IODEGEST study group. Nutritional status of iodine in pregnant women in Catalonia (Spain): study on hygiene-dietetic habits and iodine in urine. BMC Pregnancy Childbirth. 2011 Mar 8;11:17. doi: 10.1186/1471-2393-11-17.
PubMed 21385426
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status of Iodine in the Pregnant Population of Catalonia: a Study of Dietary Habits and Urinary Iodine
- ClinicalTrials.gov ID
- NCT01301768
- Acronym / sponsor ID
- PI071265
- Conditions
- Dietary Intervention, Pregnancy Jail, Iodine Deficiency
- Keywords
- Dietary Intervention, Pregnancy Jail, Iodine Deficiency, Iodine Nutrition, Dietary Habits, Urinary Iodine, Pregnancy, Group Education
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the intervention could not be performed. All participants received Usual clinical practice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 23 Feb 2011 (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.
The purpose of this study is to assess the effectiveness of individual education versus group education about dietary habits and iodine supplementation to decrease iodine deficiency in pregnant women
Detailed description
BACKGROUND: It is a priority to achieve an adequate nutritional status of iodine during pregnancy since iodine deficiency in this population may have repercussions on the mother during both gestation and post partum as well as on the foetus, the neonate and the child at different ages. According to the WHO, iodine deficiency is the most frequent cause of mental retardation and irrreversible cerebral lesions around the world. However, few studies have been published on the nutritional status of iodine in the pregnant population within the Primary Care setting, a health care level which plays an essential role in the education and control of pregnant women.
AIMS: 1.- To know the hygiene-dietetic habits related to the intake of foods rich in iodine and smoking during pregnancy. 2.- To determine the prevalence of iodine deficiency and the factors associated with its appearance during pregnancy.
METHODS/DESIGN: We will perform a cluster randomised, controlled, multicentre trial. Randomisation unit: Primary Care Team. Study population: 898 pregnant women over the age of 17 years attending consultation to a midwife during the first trimester of pregnancy in the participating primary care centres. Outcome measures: consumption of iodine-rich foods and iodine deficiency. Points of assessment: each trimester of the gestation. Intervention: group education during the first trimester of gestation on healthy hygiene-dietetic habits and the importance of an adequate iodine nutritional status. Statistical analysis: descriptive analysis of all variables will be performed as well as multilevel logistic regression. All analyses will be done carried out on an intention to treat basis and will be fitted for potential confounding factors and variables of clinical importance.
DISCUSSION: Evidence of generalised iodine deficiency during pregnancy could lead to the promotion of interventions of prevention such as how to improve and intensify health care educational programmes for pregnant women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Education | Experimental | Other: Group EducationGroup educational workshops about dietary habits in the first trimester because it is when organogenesis occurs and therefore when the iodine deficiency in the mother is an important risk in the development of the fetal central nervous system. |
| Usual care | No intervention | –Women in the control group receive the usual care during the pregnancy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant Women in the first trimester
- Over the age of 17
- Receive routine care in their respective health center
Key exclusion criteria (5 listed)
- Pregnant women who are in the second or third trimester.
- Pregnant women with diagnostic of thyroid disease.
- Pregnant women who do not have a phone.
- Pregnant women with communication difficulties (cognitive or sensory deterioration, language barrier).
- Pregnant women who do not consent to participate in the study.
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 |
|---|---|---|
| Group EducationAlso: Dietary InterventionGroup educational workshops about dietary habits in the first trimester because it is when organogenesis occurs and therefore when the iodine deficiency in the mother is an important risk in the development of the fetal central nervous system. | Other | Group Education |
Primary outcome
Iodine deficiency
Time frame: 36 weeks of pregnancy
Urinary iodine excretion below 150 µg/l
Iodine deficiency
Time frame: 24 weeks of pregnancy
Urinari iodine excretion below 150 µg/l
68 secondary outcomes
Date of birth
Time frame: At baseline
Smoking
Time frame: First trimester of pregnancy (14 weeks)
Iodized salt consumption
Time frame: First trimester of pregnancy (14 weeks)
Iodine supplementation consumption
Time frame: First trimester of pregnancy
Education Level
Time frame: At baseline
Ethnicity
Time frame: At baseline
Number of pregnancies finishes
Time frame: At baseline
Number of premature births
Time frame: At baseline
Number of abortions
Time frame: At baseline
Number of live births
Time frame: At baseline
Trimester of pregnancy
Time frame: First trimester of pregnancy
Glasses of milk a day (number)
Time frame: First trimester of pregnancy
Yogurt per week (number)
Time frame: First trimester of pregnancy
Servings of cheese per week (number)
Time frame: First trimester of pregnancy
Usual preparation of vegetables
Time frame: First trimester of pregnancy
Use of water to boil vegetables
Time frame: First trimester of pregnancy
Vegetable consumption per week (number)
Time frame: First trimester of pregnancy
Fish consumption per week (number)
Time frame: First trimester of pregnancy
Usual preparation of fish
Time frame: First trimester of pregnancy
Canned tuna consumption per week (number)
Time frame: First trimester of pregnancy
Canned sardines consumption per week (number)
Time frame: First trimester of pregnancy
Meat consumption per week (number)
Time frame: First trimester of pregnancy
Cold meat consumption per week (number)
Time frame: First trimester of pregnancy
Eggs consumption per week (number)
Time frame: First trimester or pregnancy
Fruit consumption per week (number)
Time frame: First trimester of pregnancy
Nuts consumption per week (number)
Time frame: First trimester of pregnancy
Potassium iodide consumption
Time frame: First trimester of pregnancy
Smoking
Time frame: Second trimester of pregnancy (wk 15-wk 27 )
Smoking
Time frame: Third trimester of pregnancy (wk28-wk40)
Iodized salt consumption
Time frame: Second trimester of pregnancy
Iodized salt consumption
Time frame: Third trimester of pregnancy
Iodine supplementation consumption
Time frame: Second trimester of pregnancy
Iodine supplementation consumption
Time frame: Third trimester of pregnancy
Trimester of pregnancy
Time frame: Second trimester of pregnancy
Trimester of pregnancy
Time frame: Third trimester of pregnancy
Glasses of milk a day (number)
Time frame: Second trimester of pregnancy
Glasses of milk a day (number)
Time frame: Third trimester of pregnancy
Yogurt per week (number)
Time frame: Second trimester of pregnancy
Yogurt per week (number)
Time frame: Third trimester of pregnancy
Servings of cheese per week (number)
Time frame: Second trimester of pregnancy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 21385426Prieto G, Torres MT, Frances L, Falguera G, Vila L, Manresa JM, Casamitjana R, Barrada JR, Acera A, Guix D, Torrent A, Grau J, Toran P; IODEGEST study group. Nutritional status of iodine in pregnant women in Catalonia (Spain): study on hygiene-dietetic habits and iodine in urine. BMC Pregnancy Childbirth. 2011 Mar 8;11:17. doi: 10.1186/1471-2393-11-17.
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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.
Maria Teresa Torres Costa, Midwife principal investigator
Institut Català de la Salut (ICS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Education in people with Dietary Intervention and Pregnancy Jail, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 9 Oct 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Iodine deficiency (time frame: 36 weeks of pregnancy). 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 NCT01301768, 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 9 Oct 2018.