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

NCT ID: NCT01301768

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Dietary Intervention; Pregnancy Jail; Iodine Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 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.

Group Type: EXPERIMENTAL

Group Education

Intervention Type: OTHER

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.

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group 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.

Intervention Type: OTHER

Other Intervention Names

Dietary Intervention

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

USR Metropolitana Nord

Tecnic de Recerca

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Teresa Torres Costa, Midwife

Role: PRINCIPAL_INVESTIGATOR

Institut Català de la Salut (ICS)

Locations

IDIAP Jordi Gol

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 21385426 (View on PubMed)

Other Identifiers

PI071265

Identifier Type: -

Identifier Source: org_study_id