Child-Centred Health Dialogue in Child Health Services
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| ClinicalTrials.gov Identifier: NCT04260672 |
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Recruitment Status :
Completed
First Posted : February 7, 2020
Last Update Posted : April 14, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Child, Only Child Obesity Parents | Behavioral: Child Centred Health Dialog (CCHD) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 6047 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Child-Centred Health Dialogue for Primary Prevention of Obesity in Child Health Services |
| Actual Study Start Date : | January 1, 2017 |
| Actual Primary Completion Date : | December 31, 2021 |
| Actual Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Child-Centred Health Dialogue (CCHD)
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.
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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). |
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No Intervention: usual care
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.
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- 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.
- 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
- 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.
- 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)
- 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).
- 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).
- 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.
- BMI 12 months after intervention [ Time Frame: 12 months post-intervention ]BMI measures relative weight adjusted for child age and sex.
- BMI Change [ Time Frame: 12 months post-intervention ]BMI measures relative weight adjusted for child age and sex.
- 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
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| Ages Eligible for Study: | 42 Months to 54 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260672
Show 35 study locations
| Study Chair: | Inger Hallström | Lunds University |
Publications:
| Responsible Party: | Mariette Derwig, Doctoral student, Lund University |
| ClinicalTrials.gov Identifier: | NCT04260672 |
| Other Study ID Numbers: |
2016721LUC3 |
| First Posted: | February 7, 2020 Key Record Dates |
| Last Update Posted: | April 14, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Child nutrition Child physical activity Child sleeping routines |
Child toothbrushing Parental feeding practices Parental self-efficacy |
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Obesity Pediatric Obesity Overweight |
Overnutrition Nutrition Disorders Body Weight |