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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Jordi Gol i Gurina Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01301768
First received: May 31, 2010
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Dietary Modification
Pregnancy Jail
Iodine Deficiency Syndrome
Other: Group Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutritional Status of Iodine in the Pregnant Population of Catalonia: a Study of Dietary Habits and Urinary Iodine

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Iodine deficiency [ Time Frame: 36 weeks of pregnancy ] [ Designated as safety issue: No ]
    Urinary iodine excretion below 150 µg/l

  • Iodine deficiency [ Time Frame: 24 weeks of pregnancy ] [ Designated as safety issue: No ]
    Urinari iodine excretion below 150 µg/l


Secondary Outcome Measures:
  • Date of birth [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Smoking [ Time Frame: First trimester of pregnancy (14 weeks) ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Iodized salt consumption [ Time Frame: First trimester of pregnancy (14 weeks) ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Iodine supplementation consumption [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Education Level [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Categories: can not read or write, incomplete primary, completed primary, completed secondary and university

  • Ethnicity [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Number of pregnancies finishes [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Number of premature births [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Number of abortions [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Number of live births [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Trimester of pregnancy [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Glasses of milk a day (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Yogurt per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Servings of cheese per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Usual preparation of vegetables [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  • Use of water to boil vegetables [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Vegetable consumption per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Fish consumption per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Usual preparation of fish [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  • Canned tuna consumption per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Canned sardines consumption per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Meat consumption per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Cold meat consumption per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Eggs consumption per week (number) [ Time Frame: First trimester or pregnancy ] [ Designated as safety issue: No ]
  • Fruit consumption per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Nuts consumption per week (number) [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Potassium iodide consumption [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
  • Smoking [ Time Frame: Second trimester of pregnancy (wk 15-wk 27 ) ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Smoking [ Time Frame: Third trimester of pregnancy (wk28-wk40) ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Iodized salt consumption [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Iodized salt consumption [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Iodine supplementation consumption [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Iodine supplementation consumption [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Trimester of pregnancy [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Trimester of pregnancy [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Glasses of milk a day (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Glasses of milk a day (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Yogurt per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Yogurt per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Servings of cheese per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Servings of cheese per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Usual preparation of vegetables [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  • Usual preparation of vegetables [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  • Use of water to boil vegetables [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Use of water to boil vegetables [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: yes / no

  • Vegetable consumption per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Vegetable consumption per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Fish consumption per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Fish consumption per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Usual preparation of fish [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  • Usual preparation of fish [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  • Canned tuna consumption per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Canned tuna consumption per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Canned sardines consumption per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Canned sardines consumption per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Meat consumption per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Meat consumption per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Cold meat consumption per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Cold meat consumption per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Eggs consumption per week (number) [ Time Frame: Second trimester or pregnancy ] [ Designated as safety issue: No ]
  • Eggs consumption per week (number) [ Time Frame: Third trimester or pregnancy ] [ Designated as safety issue: No ]
  • Fruit consumption per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Fruit consumption per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Nuts consumption per week (number) [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Nuts consumption per week (number) [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Potassium iodide consumption [ Time Frame: Second trimester of pregnancy ] [ Designated as safety issue: No ]
  • Potassium iodide consumption [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
  • Iodine deficiency [ Time Frame: Baseline at first trimester of pregnancy ] [ Designated as safety issue: No ]
    Urinary iodine excretion below 150 µg/l


Estimated Enrollment: 898
Study Start Date: November 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Dietary Intervention
No Intervention: Usual care
Women in the control group receive the usual care during the pregnancy

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301768

Contacts
Contact: JM Manresa, Doctor +34 93 693 2707 jmanresa@idiapjgol.info

Locations
Spain
IDIAP Jordi Gol Recruiting
Barcelona, Spain
Contact: Gemma Prieto de Lamo, Doctor    +34 653 053 135    gpljenni@gmail.com   
Contact: Josep Maria Manresa Dominguez       jmanresa@idiapjgol.info   
Sub-Investigator: Lidia Francés Ribera, Midwife         
Sub-Investigator: Gemma Falguera Puig, Midwife         
Sub-Investigator: Lluis Vila Ballester, Doctor         
Sub-Investigator: Josep Maria Manresa Dominguez         
Sub-Investigator: Roser Casamitjana Abella         
Sub-Investigator: Juan Ramon Barrada Gonzalez, Psychologist         
Sub-Investigator: Gemma Prieto de Lamo, Doctor         
Principal Investigator: Maria Teresa Torres Costa, Midwife         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Principal Investigator: Maria Teresa Torres Costa, Midwife Institut Català de la Salut (ICS)
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Teresa Torres Costa, Institut Català de la Salut (ICS)
ClinicalTrials.gov Identifier: NCT01301768     History of Changes
Other Study ID Numbers: PI071265    
Study First Received: May 31, 2010
Last Updated: February 22, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Jordi Gol i Gurina Foundation:
Dietary Intervention
Pregnancy Jail
Iodine Deficiency
Iodine Nutrition
Dietary Habits
Urinary Iodine
Pregnancy
Group Education
Cluster Randomized Trial
Primary Health Care

Additional relevant MeSH terms:
Iodine
Anti-Infective Agents
Anti-Infective Agents, Local
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on November 19, 2014