Family-based Childhood Behavior Intervention to Decrease Environmental Melamine and Phthalate Exposure

NCT02724722 | Completed

• 1 other identifier: KMU-TP103A23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Melamine and phthalates are environmental emerging chemicals, which are ubiquitously present in the public and easily contacted by children through air, foods, and skin. This study aims to examine whether the use of family-based behavior intervention by providing simple flyers plus face-to-face health education point-by-point and give one bag containing stainless steel-made tableware for eating out use to study children's mothers or main-care givers can significantly decrease melamine and phthalates exposure by measuring urinary melamine and metabolites of phthalates (especially DEHP metabolites) in study children and their mothers or main-care givers, when compared to those provided simple flyers only.

Conditions

Healthy Children and Their Main-care Giver

Keywords

melamine; phthalate

Outcome Measures

Primary Outcomes (2)

• urinary excretion of melamine

  2 weeks

• urinary excretion of five DEHP metabolites (MEHP, 5OH-MEHP, 5oxo-MEHP, 5carboxy-MEPP, and 2carboxy-MMHP)

  2 weeks

Secondary Outcomes (4)

• oxidative stress markers (8-OHdG, MDA)

  6 months

• other six phthalate metabolites of MnBP, MiBP, MEP, MBzP, MMP, and MiNP

  2 weeks

• oxidative stress markers (8-OHdG, MDA)

  one year

• renal injury markers (NAG, microalbumin, beta-2-microglobulin)

  one year

Study Arms (2)

Intervention

EXPERIMENTAL

a simple flyer in one empty bag with face-to-face health education

Behavioral: Assigned intervention

No Intervention

PLACEBO COMPARATOR

a simple flyer in one empty bag with no face-to-face health education

Behavioral: No intervention

Interventions

Assigned intervention BEHAVIORAL

a simple flyer plus face-to-face health education and give one bag containing stainless steel-made tableware for eating out use

Intervention

No intervention BEHAVIORAL

a simple flyer only with no face-to-face health education and give one bag not containing stainless steel-made tableware for eating out use

No Intervention

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• yrs healthy children and their main-care givers (i.e., mothers or grandmothers)

You may not qualify if:

• Children with any hormone treatment or major chronic diseases such as cancer

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung, Taiwan, 807, Taiwan

Location

Related Publications (2)

• Wu MT, Wu CF, Chen BH, Chen EK, Chen YL, Shiea J, Lee WT, Chao MC, Wu JR. Intake of phthalate-tainted foods alters thyroid functions in Taiwanese children. PLoS One. 2013;8(1):e55005. doi: 10.1371/journal.pone.0055005. Epub 2013 Jan 30.

  PMID: 23383031 BACKGROUND

• Wu CF, Chen BH, Shiea J, Chen EK, Liu CK, Chao MC, Ho CK, Wu JR, Wu MT. Temporal changes of urinary oxidative metabolites of di(2-ethylhexyl)phthalate after the 2011 phthalate incident in Taiwanese children: findings of a six month follow-up. Environ Sci Technol. 2013 Dec 3;47(23):13754-62. doi: 10.1021/es403141u. Epub 2013 Nov 18.

  PMID: 24191740 BACKGROUND

Study Officials

• Ming-Tsang Wu, MD, ScD

  Kaohsiung Medical University

  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: Professor

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 31, 2016
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

TW (1)