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

Iodine Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01301768
• Other study ID #: PI071265
• Status: Withdrawn
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: October 2018
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Intervention
• Iodine Deficiency
• Pregnancy Jail

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iodine deficiency	Urinary iodine excretion below 150 µg/l	36 weeks of pregnancy
Primary	Iodine deficiency	Urinari iodine excretion below 150 µg/l	24 weeks of pregnancy
Secondary	Date of birth		At baseline
Secondary	Smoking	Categories: yes / no	First trimester of pregnancy (14 weeks)
Secondary	Iodized salt consumption	Categories: yes / no	First trimester of pregnancy (14 weeks)
Secondary	Iodine supplementation consumption	Categories: yes / no	First trimester of pregnancy
Secondary	Education Level	Categories: can not read or write, incomplete primary, completed primary, completed secondary and university	At baseline
Secondary	Ethnicity		At baseline
Secondary	Number of pregnancies finishes		At baseline
Secondary	Number of premature births		At baseline
Secondary	Number of abortions		At baseline
Secondary	Number of live births		At baseline
Secondary	Trimester of pregnancy	Categories: yes / no	First trimester of pregnancy
Secondary	Glasses of milk a day (number)		First trimester of pregnancy
Secondary	Yogurt per week (number)		First trimester of pregnancy
Secondary	Servings of cheese per week (number)		First trimester of pregnancy
Secondary	Usual preparation of vegetables	Categories: raw, fried, grilled / baked, steamed and boiled	First trimester of pregnancy
Secondary	Use of water to boil vegetables	Categories: yes / no	First trimester of pregnancy
Secondary	Vegetable consumption per week (number)		First trimester of pregnancy
Secondary	Fish consumption per week (number)		First trimester of pregnancy
Secondary	Usual preparation of fish	Categories: raw, fried, grilled / baked, steamed and boiled	First trimester of pregnancy
Secondary	Canned tuna consumption per week (number)		First trimester of pregnancy
Secondary	Canned sardines consumption per week (number)		First trimester of pregnancy
Secondary	Meat consumption per week (number)		First trimester of pregnancy
Secondary	Cold meat consumption per week (number)		First trimester of pregnancy
Secondary	Eggs consumption per week (number)		First trimester or pregnancy
Secondary	Fruit consumption per week (number)		First trimester of pregnancy
Secondary	Nuts consumption per week (number)		First trimester of pregnancy
Secondary	Potassium iodide consumption		First trimester of pregnancy
Secondary	Smoking	Categories: yes / no	Second trimester of pregnancy (wk 15-wk 27 )
Secondary	Smoking	Categories: yes / no	Third trimester of pregnancy (wk28-wk40)
Secondary	Iodized salt consumption	Categories: yes / no	Second trimester of pregnancy
Secondary	Iodized salt consumption	Categories: yes / no	Third trimester of pregnancy
Secondary	Iodine supplementation consumption	Categories: yes / no	Second trimester of pregnancy
Secondary	Iodine supplementation consumption	Categories: yes / no	Third trimester of pregnancy
Secondary	Trimester of pregnancy	Categories: yes / no	Second trimester of pregnancy
Secondary	Trimester of pregnancy	Categories: yes / no	Third trimester of pregnancy
Secondary	Glasses of milk a day (number)		Second trimester of pregnancy
Secondary	Glasses of milk a day (number)		Third trimester of pregnancy
Secondary	Yogurt per week (number)		Second trimester of pregnancy
Secondary	Yogurt per week (number)		Third trimester of pregnancy
Secondary	Servings of cheese per week (number)		Second trimester of pregnancy
Secondary	Servings of cheese per week (number)		Third trimester of pregnancy
Secondary	Usual preparation of vegetables	Categories: raw, fried, grilled / baked, steamed and boiled	Second trimester of pregnancy
Secondary	Usual preparation of vegetables	Categories: raw, fried, grilled / baked, steamed and boiled	Third trimester of pregnancy
Secondary	Use of water to boil vegetables	Categories: yes / no	Second trimester of pregnancy
Secondary	Use of water to boil vegetables	Categories: yes / no	Third trimester of pregnancy
Secondary	Vegetable consumption per week (number)		Second trimester of pregnancy
Secondary	Vegetable consumption per week (number)		Third trimester of pregnancy
Secondary	Fish consumption per week (number)		Second trimester of pregnancy
Secondary	Fish consumption per week (number)		Third trimester of pregnancy
Secondary	Usual preparation of fish	Categories: raw, fried, grilled / baked, steamed and boiled	Second trimester of pregnancy
Secondary	Usual preparation of fish	Categories: raw, fried, grilled / baked, steamed and boiled	Third trimester of pregnancy
Secondary	Canned tuna consumption per week (number)		Second trimester of pregnancy
Secondary	Canned tuna consumption per week (number)		Third trimester of pregnancy
Secondary	Canned sardines consumption per week (number)		Second trimester of pregnancy
Secondary	Canned sardines consumption per week (number)		Third trimester of pregnancy
Secondary	Meat consumption per week (number)		Second trimester of pregnancy
Secondary	Meat consumption per week (number)		Third trimester of pregnancy
Secondary	Cold meat consumption per week (number)		Second trimester of pregnancy
Secondary	Cold meat consumption per week (number)		Third trimester of pregnancy
Secondary	Eggs consumption per week (number)		Second trimester or pregnancy
Secondary	Eggs consumption per week (number)		Third trimester or pregnancy
Secondary	Fruit consumption per week (number)		Second trimester of pregnancy
Secondary	Fruit consumption per week (number)		Third trimester of pregnancy
Secondary	Nuts consumption per week (number)		Second trimester of pregnancy
Secondary	Nuts consumption per week (number)		Third trimester of pregnancy
Secondary	Potassium iodide consumption		Second trimester of pregnancy
Secondary	Potassium iodide consumption		Third trimester of pregnancy
Secondary	Iodine deficiency	Urinary iodine excretion below 150 µg/l	Baseline at first trimester of pregnancy