Clinical trial NCT04260672: Child-Centred Health Dialogue in Child Health Services
Official title: Child-Centred Health Dialogue for Primary Prevention of Obesity in Child Health Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Child Obesity
Parents
Keywords: Child nutrition
Child physical activity
Child sleeping routines
Child toothbrushing
Parental feeding practices
Parental self-efficacy
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Region Skane
name: Forte
First posted: 2020-02-07
Enrollment: 6047
Sex: ALL
Minimum age (years): 42
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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:

-

Primary outcomes:
measure: Change in BMI standard deviation (SD) scores
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Children's dietary intake, physical activity, sleeping and tooth brushing routines
timeFrame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
measure: Parents self-efficacy for promoting healthy physical activity and dietary behaviors (PSEPAD) in children
timeFrame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
measure: Parental feeding practices concerning parents of preschool-aged children (CFQ)
timeFrame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
measure: Number of referrals for overweight to other caregivers
timeFrame: at 4 years old
measure: Number of extra visits between the regular visits at 4 and 5 years of age
timeFrame: 12 months post-intervention
measure: BMI standard deviation (SD) scores 12 months after intervention
timeFrame: 12 months post-intervention
measure: BMI 12 months after intervention
timeFrame: 12 months post-intervention
measure: BMI Change
timeFrame: 12 months post-intervention
measure: Costs
timeFrame: 12 months post-intervention
Other outcomes:
Locations:
city: Anderslöv
country: Sweden
facility: Barnavårdscentralen Anderslöv
city: Bara
country: Sweden
facility: Barnavårdscentralen Bokskogen
city: Eslöv
country: Sweden
facility: Barnavårdscentralen Kärråkra
city: Eslöv
country: Sweden
facility: BVC Brahehälsan Eslöv
city: Helsingborg
country: Sweden
facility: Adolfsbergs BVC
city: Helsingborg
country: Sweden
facility: Barnavårdscentralen Brunnen
city: Helsingborg
country: Sweden
facility: BVC Capio Citykliniken Mariastaden
city: Helsingborg
country: Sweden
facility: BVC Capio Citykliniken Olympiakliniken
city: Helsingborg
country: Sweden
facility: BVC Väla
city: Helsingborg
country: Sweden
facility: Familjecentral Fröhuset
city: Helsingborg
country: Sweden
facility: Helsingborgs Barnavårdscentral
city: Kävlinge
country: Sweden
facility: Barnavårdscentralen Kävlinge
city: Landskrona
country: Sweden
facility: BVC Capio Citykliniken Landskrona
city: Landskrona
country: Sweden
facility: BVC Familjecentralen Tellus
city: Laröd
country: Sweden
facility: Barnavårdscentralen Laröd
city: Malmö
country: Sweden
facility: Barnavårdscentralen Bunkeflo
city: Malmö
country: Sweden
facility: Barnavårdscentralen Granbacksvägen
city: Malmö
country: Sweden
facility: Barnavårdscentralen Grankotten
city: Malmö
country: Sweden
facility: Barnavårdscentralen Kirseberg
city: Malmö
country: Sweden
facility: Barnavårdscentralen Limhamn
city: Malmö
country: Sweden
facility: Barnavårdscentralen Lunden
city: Malmö
country: Sweden
facility: Barnavårdscentralen Nalle
city: Malmö
country: Sweden
facility: Barnavårdscentralen Oxie
city: Malmö
country: Sweden
facility: Barnavårdscentralen Sorgenfrimottagningen
city: Malmö
country: Sweden
facility: BVC Capio Citykliniken Limhamn
city: Malmö
country: Sweden
facility: BVC Capio Citykliniken Singelgatan
city: Malmö
country: Sweden
facility: BVC Capio Citykliniken Västra Hamnen
city: Malmö
country: Sweden
facility: BVC Familjecentralen Sesam
city: Malmö
country: Sweden
facility: BVC Victoria Vård och Hälsa
city: Malmö
country: Sweden
facility: Emma Barnavård på Cura
city: Malmö
country: Sweden
facility: Familjens Hus Södervärn
city: Malmö
country: Sweden
facility: Örestadsklinikens Barnavårdscentral
city: Skurup
country: Sweden
facility: Barnavårdscentralen Skurup
city: Staffanstorp
country: Sweden
facility: Barnavårdscentralen Familjecentralen Paletten
city: Trelleborg
country: Sweden
facility: BVC Valens Läkargrupp
Study officials:
affiliation: Lunds University
name: Inger Hallström
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
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.
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.
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.
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.
citation: 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.