The Use of a Communication Tool About Diet

NCT ID: NCT02266953

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 686 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-05
• Study Completion Date: 2020-04-13

Brief Summary

The purpose of this study is to promote optimal nutrition for the child based on the public health nurse's family-focused conversations at the child health centre. An image based communication tool is used in an intervention in order to promote dialogue and active participation by the parents about themes concerning food and feeding practices.

Detailed Description

Norway, as other Nordic countries, has a long-standing tradition of extensive and freely available health care for children under school age at the child health centre. Virtually all parents with small children use these child health centres, having regular encounters with public health nurses. This service aims at promoting health and preventing disease in the population. However, when comes to content and performance of conversation about food and feeding practices there are no guidelines regarding how to adapt the information to the individual child and to his or her family after infancy and up to two years of age.

The overall purpose of this study is to promote optimal nutrition for the child based on the public health nurse's family-focused conversations at the child health centre.

The design of the study is a cluster randomized controlled trial. Statistics Norway has on the basis of a systematic match drawn samples of five pairs of municipalities in Norway. It is random which municipality in each match is extracted respectively to intervention or control municipality.

Public health nurses on child health centres within intervention municipalities will use a communication tool about food and feeding practices in their encounters with participating children and parents when the child is 10-, 12- and 15-18 months old. In the control municipalities corresponding encounters will be as usual, without use of the actual communication tool. The parents will answer a food frequency questionnaire on behalf of their child when the child is 10 months old (baseline) and at the age of two years (final measurement).

Sample size consideration: The aim of the study is to reveal change in vegetable intake. The investigators keep level of statistical significance at the customary 5 % and statistical power of 80 % (beta equal to 20 %), the investigators would need 176 children in each group to reveal the change described above as statistically significant.

The investigators expect some drop out and given that their estimate might be slightly higher, the investigators want to enroll 300 children in each group to make sure our study is sufficiently powered.

Plan for missing data: Concerning missing data the investigators will use mixed models for repeated measure, imputation of missing data will therefore not be necessary. All data will be analysed according to Intention to treat (ITT) analysis.

Analytical principles: Unadjusted (or crude) differences between intervention and control group will be assessed with t-tests (for continuous variables) and Chi-square tests (when we test for association between pairs of categorical data).

In case of continuous outcome variables, the investigators will model the differences between groups (scores from the questionnaires) using uni- and multiple linear regression methods.

All regression models will be conditioned on district variable and not individual level because the randomization was performed on district variable level.

The investigators treat this study as an exploratory analysis, however, they will fit several statistical models and perform several tests therefore a correction for multiple testing will be performed. P-values < 0,01 will be considered statistically significant.

Conditions

Dietary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Use of communication tool about diet

The children and parents in the intervention group are visiting consultations at the child health centre where the public health nurses use a communication tool about diet in order to promote dialogue about themes concerning food and feeding practices. This intervention is carried out at consultations when the child is 10-, 12- and 15-18 months old.

Group Type: EXPERIMENTAL

Use of communication tool about diet

Intervention Type: BEHAVIORAL

The experimental intervention comprise the public health nurse's use of an image based communication tool in her dialogue with the family. This is in order to act in a patient centered way to facilitate participation by the parents and focus on relevant food and feeding practices from the parents' point of view.

Treatment as usual

The children and parents in the control group are visiting consultations at the child health centre where the public health nurses will conduct the consultations as usual and without use of the actual communication tool about diet. The consultations are carried out when the child is 10-, 12- and 15-18 months old.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

The public health nurses at child health centres in control municipalities are performing consultations at the child health centres as usual and without using the particular communication tool about diet.

Interventions

Use of communication tool about diet

The experimental intervention comprise the public health nurse's use of an image based communication tool in her dialogue with the family. This is in order to act in a patient centered way to facilitate participation by the parents and focus on relevant food and feeding practices from the parents' point of view.

Intervention Type: BEHAVIORAL

Treatment as usual

The public health nurses at child health centres in control municipalities are performing consultations at the child health centres as usual and without using the particular communication tool about diet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. All parents and their children, regardless of the parents' country of origin or native language, who visit the child health centre when the particular child is six months old.

2. Parents that perceive themselves to have sufficient knowledge of Norwegian language to understand the information sheet in Norwegian about the study.

Exclusion Criteria

1. Parents and their children who do not visit the child health centre when the particular child is six months old.

2. Parents who do not experience to have sufficient knowledge of Norwegian to read and understand the written Norwegian information about the study.

3. The youngest twin and the midst and youngest triplet if the child is a twin or triplet.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari Glavin, PhD

Role: STUDY_CHAIR

Oslo Metropolitan University

Sølvi Helseth, Professor

Role: STUDY_CHAIR

Oslo Metropolitan University

Locations

Oslo and Akershus University College of Applied Sciences

Oslo, , Norway

Countries

Norway

References

Holmberg Fagerlund B, Helseth S, Glavin K. Parental experience of counselling about food and feeding practices at the child health centre: A qualitative study. J Clin Nurs. 2019 May;28(9-10):1653-1663. doi: 10.1111/jocn.14771. Epub 2019 Jan 22.

Reference Type: DERIVED

PMID: 30618063 (View on PubMed)

Other Identifiers

2014/726

Identifier Type: -

Identifier Source: org_study_id