Child-Centred Health Dialogue in Child Health Services

April 13, 2022 updated by: Mariette Derwig, Lund University

Child-Centred Health Dialogue for Primary Prevention of Obesity in Child Health Services

Aims: The principal aim of this study is to evaluate a model of Child Centred Health Dialog (CCHD) in Child Health Services (CHS) aiming to promote a healthy lifestyle in families and prevent overweight and obesity in preschool children. The specific aims are to compare CCHD with usual care and to evaluate the effectiveness and cost-effectiveness of the CCHD for all children and specifically for children with overweight at the age of 4 years and to compare parents self-efficacy and feeding practices in families that received either CCHD or usual care Methods: A clustered non-blinded Randomised Control Trial was set up comparing usual care with a structured multicomponent child-centred health dialogue consisting of two parts: 1) a universal part directed to all children and 2) a targeted part for families where the child is identified with overweight.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity in childhood challenges our global health as it affects children's immediate health, educational achievements and quality of life. Research shows that obesity has its roots in the preschool years and that children with obesity are very likely to remain obese as adults and are at risk of developing adult morbidity. Therefore, primary prevention and lifestyle interventions are important in order to promote healthy lifestyle and reduce the likelihood of later obesity. The evidence is strong that the first years of life are critical in establishing good nutrition and physical activity behaviours.

The principal aim of the study is to evaluate a model of Child Centred Health Dialog (CCHD) in Child Health Services (CHS) aiming to promote a healthy lifestyle in families and prevent overweight and obesity in preschool children. Specific aims are to compare CCHD with usual care and to evaluate the effectiveness of the CCHD for all children and specifically for children with overweight at the age of 4 years and to compare parents self-efficacy and feeding practices in families that received either CCHD or usual care and to analyse the cost and cost effectiveness of CCHD, compared to usual care

The study is guided by the Medical Research Councils framework for complex interventions consisting of four key elements: development, feasibility/piloting, evaluation and implementation. In the feasibility phase CCHD proved to be feasible and fewer normal-weight 4-year-olds in the intervention group had developed overweight at the age of 5 compared to the control group and none had developed obesity one year after the intervention. Qualitative interview studies showed that nurses felt more comfortable using the illustrations in the conversation about healthy food habits. The nurses described the children more talkative and more involved when the illustrations were used. Parents felt that they received support, confirmation and guidance on various issues in the health dialogue. Four-year-old children liked to participate actively in CCHD, expressed their views based on their daily life but needed to understand the meaning of the information with which they interacted.

The Swedish Child Health Services (CHS) are free of charge and attended by nearly all families with young children, irrespective of social position or ethnicity. CHS provide a package of health care universally to all children aged 0-5 years and extra health visits are offered according to need. Overweight is a condition, par excellence, that exemplifies the need for this approach. However, evidence-based models that can be used in CHS for the prevention of overweight and the prevention of obesity in case of identified overweight are lacking.

The intervention CCHD was developed based on the following theories: the child's perspective, which puts the child as part of a family in the centre of thinking and practice and health literacy, meaning how people access, understand and use health information in ways which promote and maintain good health.

Study Type

Interventional

Enrollment (Actual)

6047

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Anderslöv, Sweden
        • Barnavårdscentralen Anderslöv
      • Bara, Sweden
        • Barnavårdscentralen Bokskogen
      • Eslöv, Sweden
        • Barnavårdscentralen Kärråkra
      • Eslöv, Sweden
        • BVC Brahehälsan Eslöv
      • Helsingborg, Sweden
        • Adolfsbergs BVC
      • Helsingborg, Sweden
        • Barnavårdscentralen Brunnen
      • Helsingborg, Sweden
        • BVC Capio Citykliniken Mariastaden
      • Helsingborg, Sweden
        • BVC Capio Citykliniken Olympiakliniken
      • Helsingborg, Sweden
        • BVC Väla
      • Helsingborg, Sweden
        • Familjecentral Fröhuset
      • Helsingborg, Sweden
        • Helsingborgs Barnavårdscentral
      • Kävlinge, Sweden
        • Barnavårdscentralen Kävlinge
      • Landskrona, Sweden
        • BVC Capio Citykliniken Landskrona
      • Landskrona, Sweden
        • BVC Familjecentralen Tellus
      • Laröd, Sweden
        • Barnavårdscentralen Laröd
      • Malmö, Sweden
        • Barnavårdscentralen Bunkeflo
      • Malmö, Sweden
        • Barnavårdscentralen Granbacksvägen
      • Malmö, Sweden
        • Barnavårdscentralen Grankotten
      • Malmö, Sweden
        • Barnavårdscentralen Kirseberg
      • Malmö, Sweden
        • Barnavårdscentralen Limhamn
      • Malmö, Sweden
        • Barnavårdscentralen Lunden
      • Malmö, Sweden
        • Barnavårdscentralen Nalle
      • Malmö, Sweden
        • Barnavårdscentralen Oxie
      • Malmö, Sweden
        • Barnavårdscentralen Sorgenfrimottagningen
      • Malmö, Sweden
        • BVC Capio Citykliniken Limhamn
      • Malmö, Sweden
        • BVC Capio Citykliniken Singelgatan
      • Malmö, Sweden
        • BVC Capio Citykliniken Västra Hamnen
      • Malmö, Sweden
        • BVC Familjecentralen Sesam
      • Malmö, Sweden
        • BVC Victoria Vård och Hälsa
      • Malmö, Sweden
        • Emma Barnavård på Cura
      • Malmö, Sweden
        • Familjens Hus Södervärn
      • Malmö, Sweden
        • Örestadsklinikens Barnavårdscentral
      • Skurup, Sweden
        • Barnavårdscentralen Skurup
      • Staffanstorp, Sweden
        • Barnavårdscentralen Familjecentralen Paletten
      • Trelleborg, Sweden
        • BVC Valens Läkargrupp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both intervention and control CHC units will offer all 4-year-old children and their caregivers their regular '4 year health visit'. Nurses working at the intervention CHCs offer families CCHD and nurses working at the Control CHCs offer usual care

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Child-Centred Health Dialogue (CCHD)
The intervention CCHD consists of two parts 1) a universal Child Centred Health Dialog by the CHS-nurse directed in the first place to all 4-year-olds and their families (10 minutes) and 2) a targeted Family Guidance by the CHS-nurse to families where a child is identified with overweight at the age of 4 (60 minutes). All children invites to their regular 5-yrs health visit.
Behavioral: Child Centred Health Dialog (CCHD)

The universal part of CCHD means a structured dialogue between the nurse and the child in presence of its parents using eight illustrations based on the most important practices associated with overweight in preschool children: fruit and vegetables consumption, intake of sweetened beverages and portion size, physical activity, sedentary behaviour tooth brushing and sleep routines. The health dialog is completed by demonstrating the BMI-growth chart to show BMI development to give parents an accurate weight perception, identify overweight and support parental readiness towards a healthy lifestyle.

When the child is identified with an overweight or obesity, the entire family is invited to participate in the targeted part of CCHD: the Family Guidance, a family consultation based on the evidence based Standardized Obesity Family Therapy (Nowicka, 2011).
No Intervention: usual care
Usual care for preschool children identified with overweight and obesity Usual care is performed according to national guidelines that invites all 4-year-olds to a '4-years health visit' including a health conversation. A survey on usual care in the case of identified overweight initial to this study among almost all nurses working at the participating CHCs showed that two thirds of questioned CHS-nurses used to invite families in which the child is identified with overweight for 1 or 2 extra visits outside the usual program. The majority o referred children to a dietician, or to another caregiver. All children invites to their regular 5-yrs health visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI standard deviation (SD) scores
Time Frame: 12 months post-intervention
BMI standard deviation (SD) scores also called BMI- z-scores measures relative weight adjusted for child age and sex.
12 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's dietary intake, physical activity, sleeping and tooth brushing routines
Time Frame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
Both parents fill out a questionnaire at baseline, 6 month and 12 month after the intervention based on the 2013 public health survey of children and parents in Skåne (Köhler 2017) about intake of fruit and vegetables, sweetened beverages, meal (breakfast) habits, number of family mealtimes, number of portions, hours of sedentary behaviors and physical activity, sleeping and tooth brushing routines
baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
Parents self-efficacy for promoting healthy physical activity and dietary behaviors (PSEPAD) in children
Time Frame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
The PSEPAD (Bohman, 2013) was developed for use in the context of childhood obesity prevention. The PSEPAD is a self-report measure composed of 12 items, covering three domains of interest in childhood obesity prevention: Parental Self-Efficacy (PSE) for promoting healthy dietary behaviours in children, PSE for promoting healthy physical activity behaviours in children and PSE for limit-setting of unhealthy dietary and physical activity behaviours in children. Caregivers rated the strength of their efficacy beliefs in influencing their preschool children on an 11-point Likert-type scale ranging from 0 to 10, with the following anchors: 0 = not at all, 2 = to a very low degree, 4 = to some degree, 6 = to quite a degree, 8 = to a high degree, 10 = to a very high degree. A total score is achieved by summing up the scores on the 14 items, with a high total score indicating high PSE.
baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
Parental feeding practices concerning parents of preschool-aged children (CFQ)
Time Frame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
The Child Feeding Questionnaire (CFQ) measures parental feeding practices and attitudes (Birch 2001). The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five. Validated for Sweden by Nowicka (2014)
baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
Number of referrals for overweight to other caregivers
Time Frame: at 4 years old
To test the hypothesis that CCHD is less expensive than usual care incremental cost-effectiveness ratios of CCHD compared to usual care will be calculated. The economic analyses will be performed in both a narrow health-care perspective (only health-care costs count) and in a wider societal one (including also effects outside the health-care sector, specifically parents' time costs and loss of production). In both perspectives, three types of effects are used as effectiveness indicators (a) change in BMI, (b) number of extra visits between the regular visits at 4 and 5 years of age and (c) number of referrals for overweight or obesity to other care givers (for example to dietician, General Practitioner, child specialist).
at 4 years old
Number of extra visits between the regular visits at 4 and 5 years of age
Time Frame: 12 months post-intervention
To test the hypothesis that CCHD is less expensive than usual care incremental cost-effectiveness ratios of CCHD compared to usual care will be calculated. The economic analyses will be performed in both a narrow health-care perspective (only health-care costs count) and in a wider societal one (including also effects outside the health-care sector, specifically parents' time costs and loss of production). In both perspectives, three types of effects are used as effectiveness indicators (a) change in BMI, (b) number of extra visits between the regular visits at 4 and 5 years of age and (c) number of referrals for overweight or obesity to other care givers (for example to dietician, General Practitioner, child specialist).
12 months post-intervention
BMI standard deviation (SD) scores 12 months after intervention
Time Frame: 12 months post-intervention
BMI standard deviation (SD) scores also called BMI- z-scores measures relative weight adjusted for child age and sex.
12 months post-intervention
BMI 12 months after intervention
Time Frame: 12 months post-intervention
BMI measures relative weight adjusted for child age and sex.
12 months post-intervention
BMI Change
Time Frame: 12 months post-intervention
BMI measures relative weight adjusted for child age and sex.
12 months post-intervention
Costs
Time Frame: 12 months post-intervention
health costs and effects outside the health-care sector: parental loss of productivity and costs of transportation, cost for training in intervention
12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Region Skane
Forte

Investigators

  • Study Chair: Inger Hallström, Lunds University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016721LUC3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parents

Clinical Trials on Child Centred Health Dialog (CCHD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe