Group Education to Improve the Iodine Nutrition in Pregnancy: Cluster Randomized Trial

Study Overview
=================
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.

Official Title
-----------------
Nutritional Status of Iodine in the Pregnant Population of Catalonia: a Study of Dietary Habits and Urinary Iodine

Conditions
-----------------
Dietary Intervention, Pregnancy Jail, Iodine Deficiency

Intervention / Treatment
-----------------
* Other: Group Education


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Education<br>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. | Other: Group Education<br>* 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.<br>* Other names: Dietary Intervention;|
| No Intervention: Usual care<br>Women in the control group receive the usual care during the pregnancy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iodine deficiency | Urinary iodine excretion below 150 µg/l | 36 weeks of pregnancy | 
| Iodine deficiency | Urinari iodine excretion below 150 µg/l | 24 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Date of birth |  | At baseline | 
| Smoking | Categories: yes / no | First trimester of pregnancy (14 weeks) | 
| Iodized salt consumption | Categories: yes / no | First trimester of pregnancy (14 weeks) | 
| Iodine supplementation consumption | Categories: yes / no | First trimester of pregnancy | 
| Education Level | Categories: can not read or write, incomplete primary, completed primary, completed secondary and university | At baseline | 
| Ethnicity |  | At baseline | 
| Number of pregnancies finishes |  | At baseline | 
| Number of premature births |  | At baseline | 
| Number of abortions |  | At baseline | 
| Number of live births |  | At baseline | 
| Trimester of pregnancy | Categories: yes / no | First trimester of pregnancy | 
| Glasses of milk a day (number) |  | First trimester of pregnancy | 
| Yogurt per week (number) |  | First trimester of pregnancy | 
| Servings of cheese per week (number) |  | First trimester of pregnancy | 
| Usual preparation of vegetables | Categories: raw, fried, grilled / baked, steamed and boiled | First trimester of pregnancy | 
| Use of water to boil vegetables | Categories: yes / no | First trimester of pregnancy | 
| Vegetable consumption per week (number) |  | First trimester of pregnancy | 
| Fish consumption per week (number) |  | First trimester of pregnancy | 
| Usual preparation of fish | Categories: raw, fried, grilled / baked, steamed and boiled | First trimester of pregnancy | 
| Canned tuna consumption per week (number) |  | First trimester of pregnancy | 
| Canned sardines consumption per week (number) |  | First trimester of pregnancy | 
| Meat consumption per week (number) |  | First trimester of pregnancy | 
| Cold meat consumption per week (number) |  | First trimester of pregnancy | 
| Eggs consumption per week (number) |  | First trimester or 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 | 
| Smoking | Categories: yes / no | Second trimester of pregnancy (wk 15-wk 27 ) | 
| Smoking | Categories: yes / no | Third trimester of pregnancy (wk28-wk40) | 
| Iodized salt consumption | Categories: yes / no | Second trimester of pregnancy | 
| Iodized salt consumption | Categories: yes / no | Third trimester of pregnancy | 
| Iodine supplementation consumption | Categories: yes / no | Second trimester of pregnancy | 
| Iodine supplementation consumption | Categories: yes / no | Third trimester of pregnancy | 
| Trimester of pregnancy | Categories: yes / no | Second trimester of pregnancy | 
| Trimester of pregnancy | Categories: yes / no | Third trimester of pregnancy | 
| Glasses of milk a day (number) |  | Second trimester of pregnancy | 
| Glasses of milk a day (number) |  | Third trimester of pregnancy | 
| Yogurt per week (number) |  | Second trimester of pregnancy | 
| Yogurt per week (number) |  | Third trimester of pregnancy | 
| Servings of cheese per week (number) |  | Second trimester of pregnancy | 
| Servings of cheese per week (number) |  | Third trimester of pregnancy | 
| Usual preparation of vegetables | Categories: raw, fried, grilled / baked, steamed and boiled | Second trimester of pregnancy | 
| Usual preparation of vegetables | Categories: raw, fried, grilled / baked, steamed and boiled | Third trimester of pregnancy | 
| Use of water to boil vegetables | Categories: yes / no | Second trimester of pregnancy | 
| Use of water to boil vegetables | Categories: yes / no | Third trimester of pregnancy | 
| Vegetable consumption per week (number) |  | Second trimester of pregnancy | 
| Vegetable consumption per week (number) |  | Third trimester of pregnancy | 
| Fish consumption per week (number) |  | Second trimester of pregnancy | 
| Fish consumption per week (number) |  | Third trimester of pregnancy | 
| Usual preparation of fish | Categories: raw, fried, grilled / baked, steamed and boiled | Second trimester of pregnancy | 
| Usual preparation of fish | Categories: raw, fried, grilled / baked, steamed and boiled | Third trimester of pregnancy | 
| Canned tuna consumption per week (number) |  | Second trimester of pregnancy | 
| Canned tuna consumption per week (number) |  | Third trimester of pregnancy | 
| Canned sardines consumption per week (number) |  | Second trimester of pregnancy | 
| Canned sardines consumption per week (number) |  | Third trimester of pregnancy | 
| Meat consumption per week (number) |  | Second trimester of pregnancy | 
| Meat consumption per week (number) |  | Third trimester of pregnancy | 
| Cold meat consumption per week (number) |  | Second trimester of pregnancy | 
| Cold meat consumption per week (number) |  | Third trimester of pregnancy | 
| Eggs consumption per week (number) |  | Second trimester or pregnancy | 
| Eggs consumption per week (number) |  | Third trimester or pregnancy | 
| Fruit consumption per week (number) |  | Second trimester of pregnancy | 
| Fruit consumption per week (number) |  | Third trimester of pregnancy | 
| Nuts consumption per week (number) |  | Second trimester of pregnancy | 
| Nuts consumption per week (number) |  | Third trimester of pregnancy | 
| Potassium iodide consumption |  | Second trimester of pregnancy | 
| Potassium iodide consumption |  | Third trimester of pregnancy | 
| Iodine deficiency | Urinary iodine excretion below 150 µg/l | Baseline at first trimester of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary Intervention, Pregnancy Jail, Iodine Deficiency, Iodine Nutrition, Dietary Habits, Urinary Iodine, Pregnancy, Group Education, Cluster Randomized Trial, Primary Health Care