NCT06380634

Brief Summary

Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

March 12, 2024

Last Update Submit

April 17, 2024

Conditions

Keywords

Household ProductMidwiferyPregnancy

Outcome Measures

Primary Outcomes (3)

  • Evaluation Form for Use of Domestic Chemicals and Personal Care Products

    In this form prepared by the researcher in line with the literature, the use of cosmetic products was asked with 41 product names in five main categories such as rinsed products, products applied to the skin and not rinsed, products applied to the hair, make-up products, intimate care products; Household chemicals are asked with 12 product names (Ashrap et al., 2018; Ingle et al., 2019; Preston et al., 2021; Fruh et al., 2022; Deierlein et al., 2022). The personal care product usage frequency of the experimental and control groups was asked in a 5-point Likert type at the pre-test and post-test, and then the difference in pre-test and post-test product usage was categorized as increasing, remaining the same or decreasing.

    1 year

  • Self Efficacy Competence Scale

    On a five-point Likert-type scale consisting of 23 items, each item is marked as 1-does not describe me at all, 2-describes me a little, 3-undecided, 4-describes me well, 5-describes me very well.

    1 year

  • Endocrine Disruptors Attitude Scale

    The scale consists of 21 items. The endocrine disruptors attitude scale has two sub-dimensions: consumer behavior and nutrition and hygiene. The scale was prepared as a five-point Likert type as "I completely agree", "I agree", "I am undecided", "I disagree", "I strongly disagree".

    1 year

Study Arms (1)

Experimental Group (Randomize)

EXPERIMENTAL

The sample size was determined as at least 64 people for each of the experimental and control groups, with 80% power, 0.05 margin of error and 0.5 effect level. Considering the possibility of data loss later on, 70 pregnant women (140 in total) were included in each group. The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). 357 pregnant women were evaluated for suitability for the study. 68 women did not meet the inclusion criteria and 149 women were not included because they did not agree to participate in the study. The pre-test of the study was completed with 70 experimental and 70 control groups (140 in total), and the post-test was completed with a total of 130 people, 69 experimental and 61 control groups.

Behavioral: Experimental group- Motivational Interview

Interventions

Pregnant women who applied to the gynecology clinic and met the inclusion criteria were informed about the study. Those who agreed were informed about the purpose of the research. Firstly, the Informed Volunteer and Introductory Information Form was applied to the women, then the Personal Care Products Use Evaluation Form, Self-Efficacy Scale and Endocrine Disruptors Attitude Scale were applied. Then, the experimental group was informed about the motivational interviewing technique. A total of 3 interviews were held. The final test was made at the fourth meeting.

Experimental Group (Randomize)

Eligibility Criteria

Age20 Years - 43 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being at least 18 years old
  • Education level must be at least primary school
  • Speaking Turkish
  • Having a single pregnancy between the 8th and 40th weeks
  • Using household chemicals and personal care products (any product at least once a week)

You may not qualify if:

  • Having a psychiatric illness that prevents communication,
  • Having a chronic serious physical health problem
  • Termination of pregnancy for any reason
  • Having a risky pregnancy (preeclampsia, threat of premature birth)
  • Intrauterine growth retardation, having a pregnancy with fetal anomalies
  • Working in a job that requires heavy use of chemicals, such as hairdresser, dry cleaner, beautician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Preston EV, Chan M, Nozhenko K, Bellavia A, Grenon MC, Cantonwine DE, McElrath TF, James-Todd T. Socioeconomic and racial/ethnic differences in use of endocrine-disrupting chemical-associated personal care product categories among pregnant women. Environ Res. 2021 Jul;198:111212. doi: 10.1016/j.envres.2021.111212. Epub 2021 May 3.

    PMID: 33957140BACKGROUND
  • Deierlein AL, Grayon AR, Zhu X, Sun Y, Liu X, Kohlasch K, Stein CR. Personal Care and Household Cleaning Product Use among Pregnant Women and New Mothers during the COVID-19 Pandemic. Int J Environ Res Public Health. 2022 May 6;19(9):5645. doi: 10.3390/ijerph19095645.

    PMID: 35565038BACKGROUND
  • Ashrap P, Watkins DJ, Calafat AM, Ye X, Rosario Z, Brown P, Velez-Vega CM, Alshawabkeh A, Cordero JF, Meeker JD. Elevated concentrations of urinary triclocarban, phenol and paraben among pregnant women in Northern Puerto Rico: Predictors and trends. Environ Int. 2018 Dec;121(Pt 1):990-1002. doi: 10.1016/j.envint.2018.08.020. Epub 2018 Oct 11.

    PMID: 30316544BACKGROUND
  • Fruh V, Preston EV, Quinn MR, Hacker MR, Wylie BJ, O'Brien K, Hauser R, James-Todd T, Mahalingaiah S. Urinary phthalate metabolite concentrations and personal care product use during pregnancy - Results of a pilot study. Sci Total Environ. 2022 Aug 20;835:155439. doi: 10.1016/j.scitotenv.2022.155439. Epub 2022 Apr 22.

    PMID: 35469886BACKGROUND
  • Ingle ME, Watkins D, Rosario Z, Velez Vega CM, Huerta-Montanez G, Calafat AM, Ospina M, Cordero JF, Alshawabkeh A, Meeker JD. The association of urinary organophosphate ester metabolites and self-reported personal care and household product use among pregnant women in Puerto Rico. Environ Res. 2019 Dec;179(Pt A):108756. doi: 10.1016/j.envres.2019.108756. Epub 2019 Sep 23.

    PMID: 31574449BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). The researcher included pregnant women who met the inclusion criteria in the outpatient clinics on certain days of the week, in accordance with the randomization process.
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
midwife

Study Record Dates

First Submitted

March 12, 2024

First Posted

April 24, 2024

Study Start

January 23, 2023

Primary Completion

December 31, 2023

Study Completion

February 20, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations