Caries-Obesity Prevention in Children by Modifying Risk Behaviors Among Parents With Immigrant Background-COP Study

NCT05758454 | Recruiting

• 1 other identifier: OralHCentre
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

Immigrants constitute 18.2 % of the whole population in Norway. Health inequalities were previously reported, and immigrant status has been associated with a high risk of caries and obesity in children. Lack of parental knowledge, poor communication, ethnic and cultural differences are suggested to be reasons for the observed discrepancies. Therefore, research-based knowledge about the social, psycho-social and cognitive factors, that direct health / dental health-related behavior in families with an immigrant background is needed. Aims The main goal of this project is to assess attitudes and behaviors related to health/oral health among immigrant parents with newborn children (0-6 months). Develop an intervention programs with the aim of increasing the parent's knowledge of the children's oral hygiene/food habits and to evaluate in a follow-up study the effect of intervention on parents' knowledge and attitude with regard to dental caries and obesity. Methods Parents with immigrant status will be recruited from primary health centers located in the western part of Norway when meeting for children's vaccination. Primary health care centers will be conveniently divided into an intervention and control group. Intervention in form of a health/dental health information translated into different native language will be provided for the intervention group. The control group will receive regular primary care health information. Efficacy of the intervention will be assessed as differences in change scores between intervention and control group regarding parental attitudes, knowledge and behaviors and children's quality of life related to health and oral health, children's body mass index and early childhood caries. Objective of this work are consistent with community needs to eliminate health/social inequalities and it is anticipated that a culturally adapted interventions can be implemented among immigrant families at a moderate cost.

Conditions

Oral Health

Outcome Measures

Primary Outcomes (2)

• Change in poor parental knowledge regarding children oral health

  The questionnaire applied to the parents before and after cultured adapted informational to compare intervention will be used to measure the change of the parental knowledge. The comparison will be carried out between and within the control and intervention groups.

  Response of parents to the first questionnaire when child is 6 months, and when the child is 24 months.

• Change in poor parental behavior regarding children oral health

  The questionnaire applied to the parents before and after cultured adapted informational intervention will be used to measure the change of the parental behavior. The comparison will be carried out between and within the control and intervention groups.

  Response of parents to the first questionnaire when child is 6 months, and when the child is 24 months.

Secondary Outcomes (4)

• Caries increment (Child age 24 months)

  Clinical examination when child is 24 months (Duration of clinical examination 15 minutes for each child)

• Caries increment (Child age 3 and 5 years old)

  Registration of record at child aged 3 and 5 years old (Registration 15-20 minutes for each child)

• Body Mass Index (BMI) (Child age 5 years old)

  Response of parents to the first questionnaire when child is 3 years, and when the child is 3 years of age.

• Quality of life of children /families

  Response of parents to the first questionnaire when child is 3 years, and when the child is 3 years of age.

Study Arms (1)

Oral health information

OTHER

Intervention in form of a health/dental health information translated into different native language will be provided for the intervention group

Behavioral: Caries and Obesity Prevention

Interventions

Caries and Obesity Prevention BEHAVIORAL

A culturally adapted oral health education intervention to prevent development of ECC and to improve parental oral health related knowledge and attitudes.

Also known as: COP

Oral health information

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Parents having newborn infants (0-6 months) with Non-Western immigrant background

You may not qualify if:

• The parents will be excluded if they cannot understand and sign a consent form and are not willing to follow the the clinical trial procedures.

Sponsors & Collaborators

• Oral Health Centre of Expertise in Western Norway: lead
• University of Bergen: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (2)

Health Centers

Bergen, Norway

RECRUITING

Manal Mustafa

Bergen, Norway

COMPLETED

Related Publications (3)

• Reda M, Gwanzura Ottemoller F, Mustafa M. Immigrant parents' perspectives on children's oral health and barriers to a culturally adapted intervention in Norway. Front Oral Health. 2026 Jan 6;6:1726535. doi: 10.3389/froh.2025.1726535. eCollection 2025.

  PMID: 41568138 DERIVED

• Reda M, Sen A, Astrom AN, Mustafa M. Effects of an intervention on immigrant parents' knowledge and attitudes toward their children's oral health: A cluster randomized trial in Norway. Eur J Oral Sci. 2025 Feb;133(1):e13037. doi: 10.1111/eos.13037. Epub 2025 Jan 17.

  PMID: 39821537 DERIVED

• Reda M, Sen A, Mustafa M. Prevention of caries and obesity in children with immigrant background in Norway- a study protocol for a cluster randomized controlled trial. BMC Oral Health. 2023 Sep 1;23(1):620. doi: 10.1186/s12903-023-03329-9.

  PMID: 37658341 DERIVED

Study Officials

• Ellen Berggreen, PhD

  Oral Health Centre of Expertise in Western Norway

  STUDY DIRECTOR

Central Study Contacts

Anne Nordrehaug Åstrøm, PhD

CONTACT

92086744; Anne.Aastrom@uib.no

Abhijit Sen, PhD

CONTACT

73412950; abhse@tkmidt.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: March 7, 2023
• Study Start: January 31, 2018
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)