Child-Centred Health Dialogue in Child Health Services

Child, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260672
• Other study ID #: 2016721LUC3
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6047
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Months to 54 Months

Eligibility

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:

-

Related Conditions & MeSH terms

• Child Obesity
• Child, Only
• Obesity
• Parents
• Pediatric Obesity

Intervention

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).

Locations

Country	Name	City	State
Sweden	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	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	Malmö
Sweden	Barnavårdscentralen Skurup	Skurup
Sweden	Barnavårdscentralen Familjecentralen Paletten	Staffanstorp
Sweden	BVC Valens Läkargrupp	Trelleborg

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	Forte, Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (10)

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. — View Citation

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.

Coyne I, Hallström I, Söderbäck 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. — View Citation

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. — View Citation

Derwig M, Tiberg I, Björk J, Hallström 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. — View Citation

Håkansson 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. — View Citation

Köhler 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2019 Jul 23;7:CD001871. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months post-intervention
Secondary	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	baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
Secondary	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.	baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
Secondary	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)	baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
Secondary	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).	at 4 years old
Secondary	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).	12 months post-intervention
Secondary	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.	12 months post-intervention
Secondary	BMI 12 months after intervention	BMI measures relative weight adjusted for child age and sex.	12 months post-intervention
Secondary	BMI Change	BMI measures relative weight adjusted for child age and sex.	12 months post-intervention
Secondary	Costs	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

External Links

•   illustrations used in the universal part of CCHD