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

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ClinicalTrials.gov Identifier: NCT01301768
Recruitment Status : Withdrawn (the intervention could not be performed. All participants received Usual clinical practice)
First Posted : February 23, 2011
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
USR Metropolitana Nord, Jordi Gol i Gurina Foundation

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

Condition or disease Intervention/treatment Phase
Dietary Intervention Pregnancy Jail Iodine Deficiency Other: Group Education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2008
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

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 Name: Dietary Intervention

No Intervention: Usual care
Women in the control group receive the usual care during the pregnancy



Primary Outcome Measures :
  1. Iodine deficiency [ Time Frame: 36 weeks of pregnancy ]
    Urinary iodine excretion below 150 µg/l

  2. Iodine deficiency [ Time Frame: 24 weeks of pregnancy ]
    Urinari iodine excretion below 150 µg/l


Secondary Outcome Measures :
  1. Date of birth [ Time Frame: At baseline ]
  2. Smoking [ Time Frame: First trimester of pregnancy (14 weeks) ]
    Categories: yes / no

  3. Iodized salt consumption [ Time Frame: First trimester of pregnancy (14 weeks) ]
    Categories: yes / no

  4. Iodine supplementation consumption [ Time Frame: First trimester of pregnancy ]
    Categories: yes / no

  5. Education Level [ Time Frame: At baseline ]
    Categories: can not read or write, incomplete primary, completed primary, completed secondary and university

  6. Ethnicity [ Time Frame: At baseline ]
  7. Number of pregnancies finishes [ Time Frame: At baseline ]
  8. Number of premature births [ Time Frame: At baseline ]
  9. Number of abortions [ Time Frame: At baseline ]
  10. Number of live births [ Time Frame: At baseline ]
  11. Trimester of pregnancy [ Time Frame: First trimester of pregnancy ]
    Categories: yes / no

  12. Glasses of milk a day (number) [ Time Frame: First trimester of pregnancy ]
  13. Yogurt per week (number) [ Time Frame: First trimester of pregnancy ]
  14. Servings of cheese per week (number) [ Time Frame: First trimester of pregnancy ]
  15. Usual preparation of vegetables [ Time Frame: First trimester of pregnancy ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  16. Use of water to boil vegetables [ Time Frame: First trimester of pregnancy ]
    Categories: yes / no

  17. Vegetable consumption per week (number) [ Time Frame: First trimester of pregnancy ]
  18. Fish consumption per week (number) [ Time Frame: First trimester of pregnancy ]
  19. Usual preparation of fish [ Time Frame: First trimester of pregnancy ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  20. Canned tuna consumption per week (number) [ Time Frame: First trimester of pregnancy ]
  21. Canned sardines consumption per week (number) [ Time Frame: First trimester of pregnancy ]
  22. Meat consumption per week (number) [ Time Frame: First trimester of pregnancy ]
  23. Cold meat consumption per week (number) [ Time Frame: First trimester of pregnancy ]
  24. Eggs consumption per week (number) [ Time Frame: First trimester or pregnancy ]
  25. Fruit consumption per week (number) [ Time Frame: First trimester of pregnancy ]
  26. Nuts consumption per week (number) [ Time Frame: First trimester of pregnancy ]
  27. Potassium iodide consumption [ Time Frame: First trimester of pregnancy ]
  28. Smoking [ Time Frame: Second trimester of pregnancy (wk 15-wk 27 ) ]
    Categories: yes / no

  29. Smoking [ Time Frame: Third trimester of pregnancy (wk28-wk40) ]
    Categories: yes / no

  30. Iodized salt consumption [ Time Frame: Second trimester of pregnancy ]
    Categories: yes / no

  31. Iodized salt consumption [ Time Frame: Third trimester of pregnancy ]
    Categories: yes / no

  32. Iodine supplementation consumption [ Time Frame: Second trimester of pregnancy ]
    Categories: yes / no

  33. Iodine supplementation consumption [ Time Frame: Third trimester of pregnancy ]
    Categories: yes / no

  34. Trimester of pregnancy [ Time Frame: Second trimester of pregnancy ]
    Categories: yes / no

  35. Trimester of pregnancy [ Time Frame: Third trimester of pregnancy ]
    Categories: yes / no

  36. Glasses of milk a day (number) [ Time Frame: Second trimester of pregnancy ]
  37. Glasses of milk a day (number) [ Time Frame: Third trimester of pregnancy ]
  38. Yogurt per week (number) [ Time Frame: Second trimester of pregnancy ]
  39. Yogurt per week (number) [ Time Frame: Third trimester of pregnancy ]
  40. Servings of cheese per week (number) [ Time Frame: Second trimester of pregnancy ]
  41. Servings of cheese per week (number) [ Time Frame: Third trimester of pregnancy ]
  42. Usual preparation of vegetables [ Time Frame: Second trimester of pregnancy ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  43. Usual preparation of vegetables [ Time Frame: Third trimester of pregnancy ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  44. Use of water to boil vegetables [ Time Frame: Second trimester of pregnancy ]
    Categories: yes / no

  45. Use of water to boil vegetables [ Time Frame: Third trimester of pregnancy ]
    Categories: yes / no

  46. Vegetable consumption per week (number) [ Time Frame: Second trimester of pregnancy ]
  47. Vegetable consumption per week (number) [ Time Frame: Third trimester of pregnancy ]
  48. Fish consumption per week (number) [ Time Frame: Second trimester of pregnancy ]
  49. Fish consumption per week (number) [ Time Frame: Third trimester of pregnancy ]
  50. Usual preparation of fish [ Time Frame: Second trimester of pregnancy ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  51. Usual preparation of fish [ Time Frame: Third trimester of pregnancy ]
    Categories: raw, fried, grilled / baked, steamed and boiled

  52. Canned tuna consumption per week (number) [ Time Frame: Second trimester of pregnancy ]
  53. Canned tuna consumption per week (number) [ Time Frame: Third trimester of pregnancy ]
  54. Canned sardines consumption per week (number) [ Time Frame: Second trimester of pregnancy ]
  55. Canned sardines consumption per week (number) [ Time Frame: Third trimester of pregnancy ]
  56. Meat consumption per week (number) [ Time Frame: Second trimester of pregnancy ]
  57. Meat consumption per week (number) [ Time Frame: Third trimester of pregnancy ]
  58. Cold meat consumption per week (number) [ Time Frame: Second trimester of pregnancy ]
  59. Cold meat consumption per week (number) [ Time Frame: Third trimester of pregnancy ]
  60. Eggs consumption per week (number) [ Time Frame: Second trimester or pregnancy ]
  61. Eggs consumption per week (number) [ Time Frame: Third trimester or pregnancy ]
  62. Fruit consumption per week (number) [ Time Frame: Second trimester of pregnancy ]
  63. Fruit consumption per week (number) [ Time Frame: Third trimester of pregnancy ]
  64. Nuts consumption per week (number) [ Time Frame: Second trimester of pregnancy ]
  65. Nuts consumption per week (number) [ Time Frame: Third trimester of pregnancy ]
  66. Potassium iodide consumption [ Time Frame: Second trimester of pregnancy ]
  67. Potassium iodide consumption [ Time Frame: Third trimester of pregnancy ]
  68. Iodine deficiency [ Time Frame: Baseline at first trimester of pregnancy ]
    Urinary iodine excretion below 150 µg/l



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301768


Locations
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Spain
IDIAP Jordi Gol
Barcelona, Spain
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
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Principal Investigator: Maria Teresa Torres Costa, Midwife Institut Català de la Salut (ICS)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: USR Metropolitana Nord, Tecnic de Recerca, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01301768     History of Changes
Other Study ID Numbers: PI071265
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Keywords provided by USR Metropolitana Nord, 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:
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Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs