NCT02266953

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
686

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 5, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2020

Completed
Last Updated

May 7, 2020

Status Verified

December 1, 2019

Enrollment Period

3.5 years

First QC Date

October 8, 2014

Last Update Submit

May 6, 2020

Conditions

Keywords

Dietary servicesPublic Health NursingPreschool child

Outcome Measures

Primary Outcomes (1)

  • Increase in the daily intake of vegetables

    Metrics are based on parents answering Food Frequency Questionnaires (FFQs) on behalf of their child, at baseline and at endpoint. In addition to questions about the child's diet, there are questions about the child's weight and length at birth, six months, 10 months and 2 years. Both FFQs are updated versions, based on validated and standardized FFQs used in earlier national dietary surveys among infants and toddlers in Norway, conducted under the auspices of the University of Oslo, the Norwegian Food Safety Authority and the Norwegian Ministry of Health and Care Services (Spedkost \[Infant Diet\] 2006-2007 (IS-1635); Småbarnskost \[Toddler Diet\] 2007 (IS-1731)). Analyses of the data will be conducted by use of a diet calculation system. The expectation is an increased intake of 15 g vegetables daily, based on average intake of vegetables of 50 g daily at the age of 1 year according to Spedkost \[Infant Diet\] 2006-2007 (IS-1635) and Småbarnskost \[Toddler Diet\]2007 (IS-1731).

    An expected average of 14 months from baseline

Secondary Outcomes (1)

  • Decreased proportion of saturated fat consumed daily

    An expected average of 14 months from baseline

Other Outcomes (1)

  • Change in body weight

    An expected average of 14 months from baseline

Study Arms (2)

Use of communication tool about diet

EXPERIMENTAL

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.

Behavioral: Use of communication tool about diet

Treatment as usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as usual

Interventions

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.

Use of communication tool about diet

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.

Treatment as usual

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Parents and their children who do not visit the child health centre when the particular child is six months old.
  • Parents who do not experience to have sufficient knowledge of Norwegian to read and understand the written Norwegian information about the study.
  • The youngest twin and the midst and youngest triplet if the child is a twin or triplet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo and Akershus University College of Applied Sciences

Oslo, N-0130, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Kari Glavin, PhD

    Oslo Metropolitan University

    STUDY CHAIR
  • Sølvi Helseth, Professor

    Oslo Metropolitan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 17, 2014

Study Start

January 5, 2015

Primary Completion

June 28, 2018

Study Completion

April 13, 2020

Last Updated

May 7, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations