NCT04260672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,047

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

5 years

First QC Date

January 29, 2020

Last Update Submit

April 13, 2022

Conditions

Keywords

Child nutritionChild physical activityChild sleeping routinesChild toothbrushingParental feeding practicesParental self-efficacy

Outcome Measures

Primary Outcomes (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.

    12 months post-intervention

Secondary Outcomes (9)

  • 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)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Child-Centred Health Dialogue (CCHD)

EXPERIMENTAL

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.

Behavioral: Child Centred Health Dialog (CCHD)

usual care

NO INTERVENTION

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.

Interventions

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).

Child-Centred Health Dialogue (CCHD)

Eligibility Criteria

Age42 Months - 54 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Barnavårdscentralen Anderslöv

Anderslöv, Sweden

Location

Barnavårdscentralen Bokskogen

Bara, Sweden

Location

Barnavårdscentralen Kärråkra

Eslöv, Sweden

Location

BVC Brahehälsan Eslöv

Eslöv, Sweden

Location

Adolfsbergs BVC

Helsingborg, Sweden

Location

Barnavårdscentralen Brunnen

Helsingborg, Sweden

Location

BVC Capio Citykliniken Mariastaden

Helsingborg, Sweden

Location

BVC Capio Citykliniken Olympiakliniken

Helsingborg, Sweden

Location

BVC Väla

Helsingborg, Sweden

Location

Familjecentral Fröhuset

Helsingborg, Sweden

Location

Helsingborgs Barnavårdscentral

Helsingborg, Sweden

Location

Barnavårdscentralen Kävlinge

Kävlinge, Sweden

Location

BVC Capio Citykliniken Landskrona

Landskrona, Sweden

Location

BVC Familjecentralen Tellus

Landskrona, Sweden

Location

Barnavårdscentralen Laröd

Laröd, Sweden

Location

Barnavårdscentralen Bunkeflo

Malmo, Sweden

Location

Barnavårdscentralen Granbacksvägen

Malmo, Sweden

Location

Barnavårdscentralen Grankotten

Malmo, Sweden

Location

Barnavårdscentralen Kirseberg

Malmo, Sweden

Location

Barnavårdscentralen Limhamn

Malmo, Sweden

Location

Barnavårdscentralen Lunden

Malmo, Sweden

Location

Barnavårdscentralen Nalle

Malmo, Sweden

Location

Barnavårdscentralen Oxie

Malmo, Sweden

Location

Barnavårdscentralen Sorgenfrimottagningen

Malmo, Sweden

Location

BVC Capio Citykliniken Limhamn

Malmo, Sweden

Location

BVC Capio Citykliniken Singelgatan

Malmo, Sweden

Location

BVC Capio Citykliniken Västra Hamnen

Malmo, Sweden

Location

BVC Familjecentralen Sesam

Malmo, Sweden

Location

BVC Victoria Vård och Hälsa

Malmo, Sweden

Location

Emma Barnavård på Cura

Malmo, Sweden

Location

Familjens Hus Södervärn

Malmo, Sweden

Location

Örestadsklinikens Barnavårdscentral

Malmo, Sweden

Location

Barnavårdscentralen Skurup

Skurup, Sweden

Location

Barnavårdscentralen Familjecentralen Paletten

Staffanstorp, Sweden

Location

BVC Valens Läkargrupp

Trelleborg, Sweden

Location

Related 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. doi: 10.1006/appe.2001.0398.

    PMID: 11358344BACKGROUND
  • 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.

    PMID: 31854251BACKGROUND
  • 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.

    PMID: 24972134BACKGROUND
  • 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.

    PMID: 28653567BACKGROUND
  • 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.

    PMID: 27141084BACKGROUND
  • 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.

    PMID: 22161367BACKGROUND
  • 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.

    PMID: 20650975BACKGROUND
  • 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.

    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.

    PMID: 18824488BACKGROUND
  • 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.

    PMID: 31666057BACKGROUND

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Inger Hallström

    Lunds University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral student

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 7, 2020

Study Start

January 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations