Dietary InterventionNCT02266953
The Use of a Communication Tool About Diet
A study testing Use of communication tool about diet and Treatment as usual in people with Dietary Intervention, run by Oslo Metropolitan University at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Dietary Intervention
- What is being tested?
- Use of communication tool about diet and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteNorway
- Study dates
- 5 Jan 2015to 13 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo and Akershus University College of Applied Sciences
Oslo, N-0130
About this study
Official title: The Use of a Communication Tool About Diet in Public Health Nurse Consultations at the Child Health Centre When the Child is Aged 10 Months to 2 Years
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.
Read the 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
- Being tested
- Use of communication tool about diet, Treatment as usual
- Keywords
- Dietary services, Public Health Nursing, Preschool child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of communication tool about dietBehavioural
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 usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: An expected average of 14 months from baseline
Secondary outcomes (1)
Decreased proportion of saturated fat consumed daily
The metrics and analyses are in accordance with those described in the section of primary outcome measure.
According to the literature, with the intervention the investigators expect a change of 10 % which means the consumption would go down to 10,8 %. Given the small proportions the investigators would need very large numbers of children to reveal such changes as statistically significant. With significance level of 5 % and power of 80 %, they would need 12 426 in each group which is not feasible for us at this stage. Therefore, the secondary aim will be treated as an exploratory analysis and the investigators only aim to describe the proportion of saturated fats consumed daily.
Measured: An expected average of 14 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start5 Jan 2015
- Primary completion28 Jun 2018
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Kari Glavin, PhD, Study chair, Oslo Metropolitan UniversitySølvi Helseth, Professor, Study chair, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266953
- Sponsor's protocol ID
- 2014/726
- Status last verified
- Dec 2019
- First submitted
- 8 Oct 2014
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30618063
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Communication Tool About Diet in Public Health Nurse Consultations at the Child Health Centre When the Child is Aged 10 Months to 2 Years
- ClinicalTrials.gov ID
- NCT02266953
- Acronym / sponsor ID
- 2014/726
- Conditions
- Dietary Intervention
- Keywords
- Dietary services, Public Health Nursing, Preschool child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 5 Jan 2015
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of communication tool about diet | Experimental | Behavioral: Use of communication tool about dietThe 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. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualThe 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. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of communication tool about dietThe 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. | Behavioural | Use of communication tool about diet |
| Treatment as usualThe 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. | Behavioural | Treatment as usual |
Primary outcome
Increase in the daily intake of vegetables
Time frame: An expected average of 14 months from baseline
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).
1 secondary outcome
Decreased proportion of saturated fat consumed daily
Time frame: An expected average of 14 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Derived from this study: PubMed 30618063Holmberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Glavin, PhD study chair
Oslo Metropolitan University
Sølvi Helseth, Professor study chair
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of communication tool about diet and Treatment as usual in people with Dietary Intervention, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in the daily intake of vegetables (time frame: An expected average of 14 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02266953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.