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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Dietary Intervention; Iodine Deficiency; Pregnancy Jail
• Intervention / Treatment: Other: Group Education

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • IDIAP Jordi Gol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Dietary Intervention
No Intervention: Usual care; 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

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Principal Investigator: Maria Teresa Torres Costa, Midwife, Institut Català de la Salut (ICS)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 31, 2010
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy; Primary Health Care; Dietary Intervention; Dietary Habits; Cluster Randomized Trial; Group Education; Iodine Deficiency; Pregnancy Jail; Iodine Nutrition; Urinary Iodine
• Other Study ID Numbers: PI071265