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Child, OnlyNCT04260672

Child-Centred Health Dialogue in Child Health Services

A study testing Child Centred Health Dialog (CCHD) in people with Child, Only and Child Obesity, run by Lund University at 35 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 42 to 54 months
Conditions the study is for
Child, Only, Child Obesity, Parents
What is being tested?
Child Centred Health Dialog (CCHD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,047 participants
Where
35 sitesSweden
Study dates
1 Jan 2017to 31 Dec 2021
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 42 to 54 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Sweden35 sites

  • Barnavårdscentralen Anderslöv

    Anderslöv

  • Barnavårdscentralen Bokskogen

    Bara

  • Barnavårdscentralen Kärråkra

    Eslöv

  • BVC Brahehälsan Eslöv

    Eslöv

  • Adolfsbergs BVC

    Helsingborg

  • Barnavårdscentralen Brunnen

    Helsingborg

  • BVC Capio Citykliniken Mariastaden

    Helsingborg

  • BVC Capio Citykliniken Olympiakliniken

    Helsingborg

  • BVC Väla

    Helsingborg

  • Familjecentral Fröhuset

    Helsingborg

  • Helsingborgs Barnavårdscentral

    Helsingborg

  • Barnavårdscentralen Kävlinge

    Kävlinge

  • BVC Capio Citykliniken Landskrona

    Landskrona

  • BVC Familjecentralen Tellus

    Landskrona

  • Barnavårdscentralen Laröd

    Laröd

  • Barnavårdscentralen Bunkeflo

    Malmö

  • Barnavårdscentralen Granbacksvägen

    Malmö

  • Barnavårdscentralen Grankotten

    Malmö

  • Barnavårdscentralen Kirseberg

    Malmö

  • Barnavårdscentralen Limhamn

    Malmö

  • Barnavårdscentralen Lunden

    Malmö

  • Barnavårdscentralen Nalle

    Malmö

  • Barnavårdscentralen Oxie

    Malmö

  • Barnavårdscentralen Sorgenfrimottagningen

    Malmö

  • BVC Capio Citykliniken Limhamn

    Malmö

  • BVC Capio Citykliniken Singelgatan

    Malmö

  • BVC Capio Citykliniken Västra Hamnen

    Malmö

  • BVC Familjecentralen Sesam

    Malmö

  • BVC Victoria Vård och Hälsa

    Malmö

  • Emma Barnavård på Cura

    Malmö

  • Familjens Hus Södervärn

    Malmö

  • Örestadsklinikens Barnavårdscentral

    Malmö

  • Barnavårdscentralen Skurup

    Skurup

  • Barnavårdscentralen Familjecentralen Paletten

    Staffanstorp

  • BVC Valens Läkargrupp

    Trelleborg

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Child Centred Health Dialog (CCHD)
Keywords
Child nutrition, Child physical activity, Child sleeping routines, Child toothbrushing, Parental feeding practices, Parental self-efficacy
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Child Centred Health Dialog (CCHD)Behavioural

    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).

Study groups in NCT04260672
Study groupRoleWhat they receive
Child-Centred Health Dialogue (CCHD)ExperimentalThe 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.
Receives: Behavioral: Child Centred Health Dialog (CCHD)
usual careNo interventionUsual 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BMI standard deviation (SD) scores

    BMI standard deviation (SD) scores also called BMI- z-scores measures relative weight adjusted for child age and sex.

    Measured: 12 months post-intervention

Secondary outcomes (9)

  1. Children's dietary intake, physical activity, sleeping and tooth brushing routines

    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

    Measured: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)

  2. Parents self-efficacy for promoting healthy physical activity and dietary behaviors (PSEPAD) in children

    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.

    Measured: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)

  3. Parental feeding practices concerning parents of preschool-aged children (CFQ)

    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)

    Measured: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)

  4. Number of referrals for overweight to other caregivers

    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).

    Measured: at 4 years old

  5. Number of extra visits between the regular visits at 4 and 5 years of age

    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).

    Measured: 12 months post-intervention

  6. BMI standard deviation (SD) scores 12 months after intervention

    BMI standard deviation (SD) scores also called BMI- z-scores measures relative weight adjusted for child age and sex.

    Measured: 12 months post-intervention

  7. BMI 12 months after intervention

    BMI measures relative weight adjusted for child age and sex.

    Measured: 12 months post-intervention

  8. BMI Change

    BMI measures relative weight adjusted for child age and sex.

    Measured: 12 months post-intervention

  9. Costs

    health costs and effects outside the health-care sector: parental loss of productivity and costs of transportation, cost for training in intervention

    Measured: 12 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start1 Jan 2017
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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
Model description
A clustered non-blinded randomised controlled trial (RCT) with two arms to determine the effectiveness (including costs and cost effectiveness) of 1) usual care (n = 3015 children) and 2) CCHD (n = 3032 children). The RCT includes 35 Child Health Centres (CHCs), located both in the country side as well as in 2 of the major cities, including areas with diverse social-economic settings.
Masking
None (open label)
Enrolment
6,047 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04260672
Sponsor's protocol ID
2016721LUC3
Status last verified
Apr 2022
First submitted
29 Jan 2020
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Birch LL, Fisher JO, Grimm-Thomas K, Markey CN, Sawyer R, Johnson SL. Confirmatory factor analysis of the Child Feeding Questionnaire: a measure of parental attitudes, beliefs and practices about child feeding and obesity proneness. Appetite. 2001 Jun;36(3):201-10. doi: 10.1006/appe.2001.0398.

    PubMed 11358344

  • Derwig M, Tiberg I, Bjork J, Hallstrom I. Child-Centred Health Dialogue for primary prevention of obesity in Child Health Services - a feasibility study. Scand J Public Health. 2021 Jun;49(4):384-392. doi: 10.1177/1403494819891025. Epub 2019 Dec 19.

    PubMed 31854251

  • Nowicka P, Sorjonen K, Pietrobelli A, Flodmark CE, Faith MS. Parental feeding practices and associations with child weight status. Swedish validation of the Child Feeding Questionnaire finds parents of 4-year-olds less restrictive. Appetite. 2014 Oct;81:232-41. doi: 10.1016/j.appet.2014.06.027. Epub 2014 Jun 24.

    PubMed 24972134

  • Kohler M, Emmelin M, Rosvall M. Parental health and psychosomatic symptoms in preschool children: A cross-sectional study in Scania, Sweden. Scand J Public Health. 2017 Dec;45(8):846-853. doi: 10.1177/1403494817705561. Epub 2017 Jun 27.

    PubMed 28653567

  • Coyne I, Hallstrom I, Soderback M. Reframing the focus from a family-centred to a child-centred care approach for children's healthcare. J Child Health Care. 2016 Dec;20(4):494-502. doi: 10.1177/1367493516642744. Epub 2016 Jul 25.

    PubMed 27141084

  • Waters E, de Silva-Sanigorski A, Hall BJ, Brown T, Campbell KJ, Gao Y, Armstrong R, Prosser L, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD001871. doi: 10.1002/14651858.CD001871.pub3.

    PubMed 22161367

  • Nowicka P, Flodmark CE. Family therapy as a model for treating childhood obesity: useful tools for clinicians. Clin Child Psychol Psychiatry. 2011 Jan;16(1):129-45. doi: 10.1177/1359104509355020. Epub 2010 Jul 22.

    PubMed 20650975

  • Bohman B, Ghaderi A, Rasmussen F. Psychometric Properties of a New Measure of Parental Self-Efficacy for Promoting Healthy Physical Activity and Dietary Behaviors in Children. European Journal of Psychological Assessment. 2013:291.

  • Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.

    PubMed 18824488

  • Hakansson L, Derwig M, Olander E. Parents' experiences of a health dialogue in the child health services: a qualitative study. BMC Health Serv Res. 2019 Oct 30;19(1):774. doi: 10.1186/s12913-019-4550-y.

    PubMed 31666057

Questions about this trial

What is this clinical trial studying?

A study testing Child Centred Health Dialog (CCHD) in people with Child, Only and Child Obesity, run by Lund University at 35 sites in Sweden.

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 1 inclusion and 1 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Sweden. 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?

Change in BMI standard deviation (SD) scores (time frame: 12 months post-intervention). 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 NCT04260672, which also lists 10 linked publications.

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 14 Apr 2022.

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