Child-Centred Health Dialogue in Child Health Services

NCT ID: NCT04260672

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6047 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2021-12-31

Brief 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. 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.

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.

Conditions

Child, Only; Child Obesity; Parents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Child Centred Health Dialog (CCHD)

Intervention Type: BEHAVIORAL

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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

-

• Minimum Eligible Age: 42 Months
• Maximum Eligible Age: 54 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: collaborator

Forte

INDUSTRY

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Mariette Derwig

Doctoral student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inger Hallström

Role: STUDY_CHAIR

Lunds University

Locations

Barnavårdscentralen Anderslöv

Anderslöv, , Sweden

Barnavårdscentralen Bokskogen

Bara, , Sweden

Barnavårdscentralen Kärråkra

Eslöv, , Sweden

BVC Brahehälsan Eslöv

Eslöv, , 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

Helsingborg, , Sweden

Barnavårdscentralen Kävlinge

Kävlinge, , Sweden

BVC Capio Citykliniken Landskrona

Landskrona, , Sweden

BVC Familjecentralen Tellus

Landskrona, , Sweden

Barnavårdscentralen Laröd

Laröd, , Sweden

Barnavårdscentralen Bunkeflo

Malmo, , Sweden

Barnavårdscentralen Granbacksvägen

Malmo, , Sweden

Barnavårdscentralen Grankotten

Malmo, , Sweden

Barnavårdscentralen Kirseberg

Malmo, , Sweden

Barnavårdscentralen Limhamn

Malmo, , Sweden

Barnavårdscentralen Lunden

Malmo, , Sweden

Barnavårdscentralen Nalle

Malmo, , Sweden

Barnavårdscentralen Oxie

Malmo, , Sweden

Barnavårdscentralen Sorgenfrimottagningen

Malmo, , Sweden

BVC Capio Citykliniken Limhamn

Malmo, , Sweden

BVC Capio Citykliniken Singelgatan

Malmo, , Sweden

BVC Capio Citykliniken Västra Hamnen

Malmo, , Sweden

BVC Familjecentralen Sesam

Malmo, , Sweden

BVC Victoria Vård och Hälsa

Malmo, , Sweden

Emma Barnavård på Cura

Malmo, , Sweden

Familjens Hus Södervärn

Malmo, , Sweden

Örestadsklinikens Barnavårdscentral

Malmo, , Sweden

Barnavårdscentralen Skurup

Skurup, , Sweden

Barnavårdscentralen Familjecentralen Paletten

Staffanstorp, , Sweden

BVC Valens Läkargrupp

Trelleborg, , Sweden

Countries

Sweden

References

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Reference Type: BACKGROUND

PMID: 11358344 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31854251 (View on PubMed)

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.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18824488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31666057 (View on PubMed)

Related Links

https://www.rikshandboken-bhv.se/metoder--riktlinjer/halsosamtal-om-levnadsvanor/grunda-sunda-vanor---pedagogiskt-bildmaterial/

illustrations used in the universal part of CCHD

Other Identifiers

2016721LUC3

Identifier Type: -

Identifier Source: org_study_id