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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Withdrawn

Conditions: Dietary Intervention; Iodine Deficiency; Pregnancy Jail

Treatments: Other: Group Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01301768

PI071265

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Group Education

Experimental group

Description:

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.

Treatment:

Other: Group Education

Usual care

No Intervention group

Description:

Women in the control group receive the usual care during the pregnancy