Dietary Intervention, Pregnancy Jail, Iodine Deficiency
Conditions
Keywords
Dietary Intervention, Pregnancy Jail, Iodine Deficiency, Iodine Nutrition, Dietary Habits, Urinary Iodine, Pregnancy, Group Education, Cluster Randomized Trial, Primary Health Care
Brief 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
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.
Interventions
OTHERGroup Education
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.
Sponsors
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant Women in the first trimester * Over the age of 17 * Receive routine care in their respective health center
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iodine deficiency | 36 weeks of pregnancy | Urinary iodine excretion below 150 µg/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eggs consumption per week (number) | First trimester or pregnancy | — |
| Usual preparation of fish | First trimester of pregnancy | Categories: raw, fried, grilled / baked, steamed and boiled |
| Canned tuna consumption per week (number) | First trimester of pregnancy | — |
| Canned sardines consumption per week (number) | First trimester of pregnancy | — |
| Glasses of milk a day (number) | First trimester of pregnancy | — |
| Meat consumption per week (number) | First trimester of pregnancy | — |
| Date of birth | At baseline | — |
| Smoking | First trimester of pregnancy (14 weeks) | Categories: yes / no |
| Iodized salt consumption | First trimester of pregnancy (14 weeks) | Categories: yes / no |
| Iodine supplementation consumption | First trimester of pregnancy | Categories: yes / no |
| Education Level | At baseline | Categories: can not read or write, incomplete primary, completed primary, completed secondary and university |
| Ethnicity | At baseline | — |
| Number of pregnancies finishes | At baseline | — |
| Cold meat consumption per week (number) | First trimester of pregnancy | — |
| Number of abortions | At baseline | — |
| Number of live births | At baseline | — |
| Trimester of pregnancy | First trimester of pregnancy | Categories: yes / no |
| Yogurt per week (number) | First trimester of pregnancy | — |
| Servings of cheese per week (number) | First trimester of pregnancy | — |
| Usual preparation of vegetables | First trimester of pregnancy | Categories: raw, fried, grilled / baked, steamed and boiled |
| Use of water to boil vegetables | First trimester of pregnancy | Categories: yes / no |
| Vegetable consumption per week (number) | First trimester of pregnancy | — |
| Fish consumption per week (number) | First trimester of pregnancy | — |
| Fruit consumption per week (number) | First trimester of pregnancy | — |
| Nuts consumption per week (number) | First trimester of pregnancy | — |
| Potassium iodide consumption | First trimester of pregnancy | — |
| Iodine deficiency | Baseline at first trimester of pregnancy | Urinary iodine excretion below 150 µg/l |
| Number of premature births | At baseline | — |
Countries
Spain
Outcome results
None listed