NCT04260672|Completed
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Sponsor study identifier
interventional
6,047
1 country
35
Study Start
January 1, 2017
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2017
Actual (reported)January 29, 2020
Actual (reported)February 7, 2020
Actual (reported)December 31, 2021
Actual (reported)December 31, 2021
Actual (reported)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
Children's dietary intake, 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
baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)
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.
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.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
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.
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.
Inger Hallström
Lunds University
6,047 participants (actual enrollment reported by the registry).
First Submitted
January 29, 2020
First Posted
February 7, 2020
Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families
Parental feeding practices concerning parents of preschool-aged children (CFQ)
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
at 4 years old
Number of extra visits between the regular visits at 4 and 5 years of age
12 months post-intervention
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, Sweden
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.
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.
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.
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.
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.
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.
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.
Study Start
January 1, 2017
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Last Updated
April 14, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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