Clinical trial NCT01301768: Group Education to Improve the Iodine Nutrition in Pregnancy: Cluster Randomized Trial
Official title: Nutritional Status of Iodine in the Pregnant Population of Catalonia: a Study of Dietary Habits and Urinary Iodine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dietary Intervention
Pregnancy Jail
Iodine Deficiency
Keywords: Dietary Intervention
Pregnancy Jail
Iodine Deficiency
Iodine Nutrition
Dietary Habits
Urinary Iodine
Pregnancy
Group Education
Cluster Randomized Trial
Primary Health Care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Iodine deficiency
timeFrame: 36 weeks of pregnancy
measure: Iodine deficiency
timeFrame: 24 weeks of pregnancy
Secondary outcomes:
measure: Date of birth
timeFrame: At baseline
measure: Smoking
timeFrame: First trimester of pregnancy (14 weeks)
measure: Iodized salt consumption
timeFrame: First trimester of pregnancy (14 weeks)
measure: Iodine supplementation consumption
timeFrame: First trimester of pregnancy
measure: Education Level
timeFrame: At baseline
measure: Ethnicity
timeFrame: At baseline
measure: Number of pregnancies finishes
timeFrame: At baseline
measure: Number of premature births
timeFrame: At baseline
measure: Number of abortions
timeFrame: At baseline
measure: Number of live births
timeFrame: At baseline
measure: Trimester of pregnancy
timeFrame: First trimester of pregnancy
measure: Glasses of milk a day (number)
timeFrame: First trimester of pregnancy
measure: Yogurt per week (number)
timeFrame: First trimester of pregnancy
measure: Servings of cheese per week (number)
timeFrame: First trimester of pregnancy
measure: Usual preparation of vegetables
timeFrame: First trimester of pregnancy
measure: Use of water to boil vegetables
timeFrame: First trimester of pregnancy
measure: Vegetable consumption per week (number)
timeFrame: First trimester of pregnancy
measure: Fish consumption per week (number)
timeFrame: First trimester of pregnancy
measure: Usual preparation of fish
timeFrame: First trimester of pregnancy
measure: Canned tuna consumption per week (number)
timeFrame: First trimester of pregnancy
measure: Canned sardines consumption per week (number)
timeFrame: First trimester of pregnancy
measure: Meat consumption per week (number)
timeFrame: First trimester of pregnancy
measure: Cold meat consumption per week (number)
timeFrame: First trimester of pregnancy
measure: Eggs consumption per week (number)
timeFrame: First trimester or pregnancy
measure: Fruit consumption per week (number)
timeFrame: First trimester of pregnancy
measure: Nuts consumption per week (number)
timeFrame: First trimester of pregnancy
measure: Potassium iodide consumption
timeFrame: First trimester of pregnancy
measure: Smoking
timeFrame: Second trimester of pregnancy (wk 15-wk 27 )
measure: Smoking
timeFrame: Third trimester of pregnancy (wk28-wk40)
measure: Iodized salt consumption
timeFrame: Second trimester of pregnancy
measure: Iodized salt consumption
timeFrame: Third trimester of pregnancy
measure: Iodine supplementation consumption
timeFrame: Second trimester of pregnancy
measure: Iodine supplementation consumption
timeFrame: Third trimester of pregnancy
measure: Trimester of pregnancy
timeFrame: Second trimester of pregnancy
measure: Trimester of pregnancy
timeFrame: Third trimester of pregnancy
measure: Glasses of milk a day (number)
timeFrame: Second trimester of pregnancy
measure: Glasses of milk a day (number)
timeFrame: Third trimester of pregnancy
measure: Yogurt per week (number)
timeFrame: Second trimester of pregnancy
measure: Yogurt per week (number)
timeFrame: Third trimester of pregnancy
measure: Servings of cheese per week (number)
timeFrame: Second trimester of pregnancy
measure: Servings of cheese per week (number)
timeFrame: Third trimester of pregnancy
measure: Usual preparation of vegetables
timeFrame: Second trimester of pregnancy
measure: Usual preparation of vegetables
timeFrame: Third trimester of pregnancy
measure: Use of water to boil vegetables
timeFrame: Second trimester of pregnancy
measure: Use of water to boil vegetables
timeFrame: Third trimester of pregnancy
measure: Vegetable consumption per week (number)
timeFrame: Second trimester of pregnancy
measure: Vegetable consumption per week (number)
timeFrame: Third trimester of pregnancy
measure: Fish consumption per week (number)
timeFrame: Second trimester of pregnancy
measure: Fish consumption per week (number)
timeFrame: Third trimester of pregnancy
measure: Usual preparation of fish
timeFrame: Second trimester of pregnancy
measure: Usual preparation of fish
timeFrame: Third trimester of pregnancy
measure: Canned tuna consumption per week (number)
timeFrame: Second trimester of pregnancy
measure: Canned tuna consumption per week (number)
timeFrame: Third trimester of pregnancy
measure: Canned sardines consumption per week (number)
timeFrame: Second trimester of pregnancy
measure: Canned sardines consumption per week (number)
timeFrame: Third trimester of pregnancy
measure: Meat consumption per week (number)
timeFrame: Second trimester of pregnancy
measure: Meat consumption per week (number)
timeFrame: Third trimester of pregnancy
measure: Cold meat consumption per week (number)
timeFrame: Second trimester of pregnancy
measure: Cold meat consumption per week (number)
timeFrame: Third trimester of pregnancy
measure: Eggs consumption per week (number)
timeFrame: Second trimester or pregnancy
measure: Eggs consumption per week (number)
timeFrame: Third trimester or pregnancy
measure: Fruit consumption per week (number)
timeFrame: Second trimester of pregnancy
measure: Fruit consumption per week (number)
timeFrame: Third trimester of pregnancy
measure: Nuts consumption per week (number)
timeFrame: Second trimester of pregnancy
measure: Nuts consumption per week (number)
timeFrame: Third trimester of pregnancy
measure: Potassium iodide consumption
timeFrame: Second trimester of pregnancy
measure: Potassium iodide consumption
timeFrame: Third trimester of pregnancy
measure: Iodine deficiency
timeFrame: Baseline at first trimester of pregnancy
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
Study officials:
affiliation: Institut Català de la Salut (ICS)
name: Maria Teresa Torres Costa, Midwife
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.