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NCT Number: NCT04260672

Child-Centred Health Dialogue in Child Health Services

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.

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Key information

Conditions

Child, Only Body Weight Child Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Parents Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

42 month–54 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnavårdscentralen Anderslöv, Anderslöv, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Child Centred Health Dialog (CCHD)

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).

Primary outcomes

  1. Change in BMI standard deviation (SD) scores

    Time frame: 12 months post-intervention

    BMI standard deviation (SD) scores also called BMI- z-scores measures relative weight adjusted for child age and sex.

Secondary outcomes

  1. Children's dietary intake, physical activity, sleeping and tooth brushing routines

    Time frame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)

    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

  2. Parents self-efficacy for promoting healthy physical activity and dietary behaviors (PSEPAD) in children

    Time frame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)

    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.

  3. Parental feeding practices concerning parents of preschool-aged children (CFQ)

    Time frame: baseline at four years old, 4 years and 6 months (6 months post-intervention) and 5 years old (12 months post-intervention)

    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)

  4. Number of referrals for overweight to other caregivers

    Time frame: at 4 years old

    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).

  5. Number of extra visits between the regular visits at 4 and 5 years of age

    Time frame: 12 months post-intervention

    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).

  6. BMI standard deviation (SD) scores 12 months after intervention

    Time frame: 12 months post-intervention

    BMI standard deviation (SD) scores also called BMI- z-scores measures relative weight adjusted for child age and sex.

  7. BMI 12 months after intervention

    Time frame: 12 months post-intervention

    BMI measures relative weight adjusted for child age and sex.

  8. BMI Change

    Time frame: 12 months post-intervention

    BMI measures relative weight adjusted for child age and sex.

  9. Costs

    Time frame: 12 months post-intervention

    health costs and effects outside the health-care sector: parental loss of productivity and costs of transportation, cost for training in intervention

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Forte
  • Region Skane

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2020
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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