Impact of a Culturally Adapted Intervention on Early Childhood Caries Among Immigrants-A Cluster-Randomised Trial.
Mariam Reda, Knut Helge M Jensen, Abhijit Sen...
https://pubmed.ncbi.nlm.nih.gov/41906192Actively Recruiting
Phase Not Applicable
Age: 20Years - 50Years
All Genders
Healthy Volunteers
ID05758454
Caries-Obesity Prevention in Children by Modifying Risk Behaviors Among Parents With Immigrant Background-COP Study Innovation Project for the Public Sector
Led by Oral Health Centre of Expertise in Western Norway · Updated on 2023-03-07
400
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
O
Oral Health Centre of Expertise in Western Norway
Lead Sponsor
U
University of Bergen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study health and oral health attitudes and behaviors among immigrant parents with newborn children aged 0 to 6 months. The focus is on understanding how social, psycho-social, and cognitive factors influence these behaviors in immigrant families in Norway. The study evaluates a culturally adapted oral health education program designed to improve parents' knowledge and attitudes toward preventing dental caries and obesity in their children. It also includes a prospective follow-up to compare these factors and children's health outcomes between immigrant and Norwegian-born families as children grow older. The study includes an intervention where immigrant parents receive health and dental care information translated into their native languages, delivered individually with practical demonstrations like tooth brushing. This intervention occurs twice within the first 6 to 8 months after birth. The control group receives standard primary care information without cultural adaptation. Later, a follow-up will assess the effects of this intervention on children's dental caries, body mass index (BMI), and oral health-related quality of life at ages 2 to 5 years. The follow-up study also includes Norwegian-born parents and their children for comparison. Participants will complete questionnaires on their knowledge, attitudes, and behaviors related to oral health and diet at multiple times: baseline (0-6 months), follow-up (18-24 months), and again when children are 3 and 5 years old. Children's dental health and BMI will be recorded from clinical exams and health records. Researchers will measure changes in parental knowledge and behaviors, children's eating habits, and children's dental and general health outcomes. The study involves interviews, clinical exams, and data collection over several years, with close monitoring to evaluate the intervention's impact.
CONDITIONS
Brief Title
Caries-Obesity Prevention in Children by Modifying Risk Behaviors Among Parents With Immigrant Background-COP Study
Who Can Participate
Age: 20Years - 50Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Parents having newborn infants (0-6 months) with Non-Western immigrant background
You will not qualify if you...
- Parents who cannot understand and sign a consent form
- Parents not willing to follow the clinical trial procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Up to 8 months
Participants receive culturally adapted oral health education to improve parental knowledge, attitudes, and behaviors related to children's oral health and feeding practices.
2 visits (in-person) during the first 8 months after the child's birth
Monitoring
Duration - 2 years
Participants and their children are followed to assess changes in parental knowledge, children's eating behavior, and oral health outcomes including dental caries and BMI between ages 3 and 5 years.
2 visits (in-person) at child ages 3 and 5 years for questionnaire interviews and clinical assessments
Trial Site Locations
Total: 2 locations
1
Health Centers
Bergen, Norway
Actively Recruiting
2
Manal Mustafa
Bergen, Norway
Completed
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Research Team
A
Anne Nordrehaug Åstrøm, PhD
A
Abhijit Sen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Immigrant parents' perspectives on children's oral health and barriers to a culturally adapted intervention in Norway.
Mariam Reda, Fungisai Gwanzura Ottemöller, Manal Mustafa
https://pubmed.ncbi.nlm.nih.gov/41568138Effects of an intervention on immigrant parents' knowledge and attitudes toward their children's oral health: A cluster randomized trial in Norway.
Mariam Reda, Abhijit Sen, Anne N Åstrøm...
https://pubmed.ncbi.nlm.nih.gov/39821537Prevention of caries and obesity in children with immigrant background in Norway- a study protocol for a cluster randomized controlled trial.
Mariam Reda, Abhijit Sen, Manal Mustafa
https://pubmed.ncbi.nlm.nih.gov/37658341