The Use of a Communication Tool About Diet
Condition: Dietary Intervention
Study type: Interventional

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.
    

Intervention name(s): Use of communication tool about diet; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dietary services; Public Health Nursing; Preschool child