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

NCT01301768 | Withdrawn DMC

• 1 other identifier: PI071265
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Dietary Intervention; Pregnancy Jail; Iodine Deficiency

Keywords

Dietary Intervention; Pregnancy Jail; Iodine Deficiency; Iodine Nutrition; Dietary Habits; Urinary Iodine; Pregnancy; Group Education; Cluster Randomized Trial; Primary Health Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (68)

• Date of birth

  At baseline

• Smoking

  First trimester of pregnancy (14 weeks)

• Iodized salt consumption

  First trimester of pregnancy (14 weeks)

• Iodine supplementation consumption

  First trimester of pregnancy

• Education Level

  At baseline

Study Arms (2)

Group Education

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

Group Education 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.

Also known as: Dietary Intervention

Group Education

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant Women in the first trimester
• Over the age of 17
• Receive routine care in their respective health center

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 21385426 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Maria Teresa Torres Costa, Midwife

  Institut Català de la Salut (ICS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tecnic de Recerca

Study Record Dates

• First Submitted: May 31, 2010
• First Posted: February 23, 2011
• Study Start: November 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

ES (1)