Family-based Childhood Behavior Intervention to Decrease Environmental Melamine and Phthalate Exposure
Condition: Healthy Children and Their Main-care Giver
Study type: Interventional

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.
    

Detailed description: 
      Study subjects: Between May 31 and June 17, 2011, 108 children visited the special Phthalates
      Clinic for Children (PCC) at Kaohsiung Medical University Hospital (KMUH). Thirteen children
      whose age was older than 10 years, one girl with a history of hormone (leuprorelin)
      treatment, and thirty-four whose parents did not sign informed consents were excluded. The
      rest of 60 children are eligible to participate in this study. Because 37 out of the 60
      potential study children did provide enough urine for the analyses of phthalates metabolites
      in our previous study [Wu et al., 2013a; Wu et al., 2013b], in this study, the investigators
      focus on the 37 study children. After the contact by phone, 24 study children and their
      mothers or main-care givers are willing to participate in this study intervention.

      Study protocol: This is a family-based randomized intervention. The investigators will
      conduct this study for 2 weeks follow up. The investigators randomly assign 12 study children
      and their main-care givers (i.e., mothers or grandmothers) to a intervention group and
      another 12 to a control group. Intervention group means study children and their main-care
      givers (i.e., mothers or grandmothers) will receive face-to-face health education, besides
      provided the simple flyers and give one bag containing stainless steel-made tableware for
      eating out use, how to avoid environmental exposure to melamine and phthalate chemicals based
      on the evidence-based data from the investigators' laboratory and other researchers. The
      investigators only provide the simple flyers in a empty bag to the control group. The
      investigators will collect two one-spot urine samples from two consecutive mornings of the
      study children and their main-care givers, usually mother or grandmothers, at the baseline.
      Blood samples of the children were also collected measurement of endocrine profile, including
      TSH, T4, FT4, T3, and E2. After 2 weeks, another two one-spot urine samples from two
      consecutive mornings of the study investigators will collect two one-spot urine samples from
      two consecutive mornings of the study children and their main-care givers, usually mother or
      grandmothers, every 3 months for analyses.
    

Intervention name(s): Assigned intervention; No intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): a simple flyer plus face-to-face health education and give one bag containing stainless steel-made tableware for eating out use; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: melamine; phthalate