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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
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.
IDIAP Jordi Gol
Barcelona, Spain
Iodine deficiency
Urinary iodine excretion below 150 µg/l
Time frame: 36 weeks of pregnancy
Iodine deficiency
Urinari iodine excretion below 150 µg/l
Time frame: 24 weeks of pregnancy
Date of birth
Time frame: At baseline
Smoking
Categories: yes / no
Time frame: First trimester of pregnancy (14 weeks)
Iodized salt consumption
Categories: yes / no
Time frame: First trimester of pregnancy (14 weeks)
Iodine supplementation consumption
Categories: yes / no
Time frame: First trimester of pregnancy
Education Level
Categories: can not read or write, incomplete primary, completed primary, completed secondary and university
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
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Number of abortions
Time frame: At baseline
Number of live births
Time frame: At baseline
Trimester of pregnancy
Categories: yes / no
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
Categories: raw, fried, grilled / baked, steamed and boiled
Time frame: First trimester of pregnancy
Use of water to boil vegetables
Categories: yes / no
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
Categories: raw, fried, grilled / baked, steamed and boiled
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
Categories: yes / no
Time frame: Second trimester of pregnancy (wk 15-wk 27 )
Smoking
Categories: yes / no
Time frame: Third trimester of pregnancy (wk28-wk40)
Iodized salt consumption
Categories: yes / no
Time frame: Second trimester of pregnancy
Iodized salt consumption
Categories: yes / no
Time frame: Third trimester of pregnancy
Iodine supplementation consumption
Categories: yes / no
Time frame: Second trimester of pregnancy
Iodine supplementation consumption
Categories: yes / no
Time frame: Third trimester of pregnancy
Trimester of pregnancy
Categories: yes / no
Time frame: Second trimester of pregnancy
Trimester of pregnancy
Categories: yes / no
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
Servings of cheese per week (number)
Time frame: Third trimester of pregnancy
Usual preparation of vegetables
Categories: raw, fried, grilled / baked, steamed and boiled
Time frame: Second trimester of pregnancy
Usual preparation of vegetables
Categories: raw, fried, grilled / baked, steamed and boiled
Time frame: Third trimester of pregnancy
Use of water to boil vegetables
Categories: yes / no
Time frame: Second trimester of pregnancy
Use of water to boil vegetables
Categories: yes / no
Time frame: Third trimester of pregnancy
Vegetable consumption per week (number)
Time frame: Second trimester of pregnancy
Vegetable consumption per week (number)
Time frame: Third trimester of pregnancy
Fish consumption per week (number)
Time frame: Second trimester of pregnancy
Fish consumption per week (number)
Time frame: Third trimester of pregnancy
Usual preparation of fish
Categories: raw, fried, grilled / baked, steamed and boiled
Time frame: Second trimester of pregnancy
Usual preparation of fish
Categories: raw, fried, grilled / baked, steamed and boiled
Time frame: Third trimester of pregnancy
Canned tuna consumption per week (number)
Time frame: Second trimester of pregnancy
Canned tuna consumption per week (number)
Time frame: Third trimester of pregnancy
Canned sardines consumption per week (number)
Time frame: Second trimester of pregnancy
Canned sardines consumption per week (number)
Time frame: Third trimester of pregnancy
Meat consumption per week (number)
Time frame: Second trimester of pregnancy
Meat consumption per week (number)
Time frame: Third trimester of pregnancy
Cold meat consumption per week (number)
Time frame: Second trimester of pregnancy
Cold meat consumption per week (number)
Time frame: Third trimester of pregnancy
Eggs consumption per week (number)
Time frame: Second trimester or pregnancy
Eggs consumption per week (number)
Time frame: Third trimester or pregnancy
Fruit consumption per week (number)
Time frame: Second trimester of pregnancy
Fruit consumption per week (number)
Time frame: Third trimester of pregnancy
Nuts consumption per week (number)
Time frame: Second trimester of pregnancy
Nuts consumption per week (number)
Time frame: Third trimester of pregnancy
Potassium iodide consumption
Time frame: Second trimester of pregnancy
Potassium iodide consumption
Time frame: Third trimester of pregnancy
Iodine deficiency
Urinary iodine excretion below 150 µg/l
Time frame: Baseline at first trimester of pregnancy