Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011065

Trial Description

start of 1:1-Block title

Title

Evaluation of the health effects of „JolinchenKids – Fit and healthy in daycare”, a program for health promotion targeting 3-6 year-old children, at 68 daycare facilities in Germany

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

JOKITA

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.bips-institut.de/en/research/projects/detail-view.html?projID=653&cHash=c70964f58bf00c64b325d289acecb471

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aims of the JOKITA study are to evaluate health effects of the program „Jolinchenkids – Fit and healthy in daycare“ which was previously developed by the AOK health insurance in collaboration with scientists and other experts in the fields of nutrition and physical activity. In addition, program-related structural changes at the daycare facilities will be examined. Furthermore, views of heads of daycare facilities and parents on factors facilitating /impeding program implementation will be assessed and recommendations for the implementation of future programs for health promotion in this setting will be provided. The program „Jolinchenkids – Fit and healthy in daycare“ is aimed at improving physical activity, diet, and mental well-being in 3-6 year-old children (i.e., a maximum of five years of age at baseline) that are taken care of in kindergarten groups at daycare facilities. To evaluate program efficacy, a controlled intervention study will be conducted. Daycare facilities will be recruited nationwide. Sixty-eight daycare facilities will participate in the study, including 34 that will implement the program in 2016 (“intervention daycare facilities”) and 34 daycare facilities that will be waitlisted and will start the program after the follow-up assessment is completed (“control daycare facilities”). Short-term effects of the program will be evaluated by assessing children’s height, weight, and motor skills at baseline and 12-months follow-up. Children’s diet, physical activity, and mental well-being will be assessed via parental questionnaires and health behaviors and health literacy among daycare staff will be assessed via questionnaires as well, both at baseline and 12-months follow-up.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The main aim of the study is to evaluate the efficacy of a daycare-based intervention for the promotion of physical activity, a balanced diet, and mental well-being in 3-6 year-old children at 68 daycare facilities nationwide. The intervention „Jolinchenkids – Fit and healthy in daycare“ (Jolinchenkids) was previously developed by the AOK health insurance in collaboration with scientists and other experts in the fields of nutrition and physical activity and is currently implemented nationwide. The following questions are examined in the study:
a.) Which health effects can be observed among children as a result of participating in „Jolinchenkids – Fit and healthy in daycare“?
b.) How does program implementation influence structural conditions at the participating daycare facilities?
c.) Which factors facilitate/impede reaching program aims, program implementation and the acceptance of the program among children, parents, and daycare staff?
Mixed methods, including quantitative as well as qualitative methods, will be employed to answer the research questions. Three components are planned: I.) a controlled intervention study, including anthropometric measurements and an objective assessment of physical activity in children using accelerometers, as well as questionnaires for parents and daycare staff (baseline, 12-months follow-up), II.) a telephone-based survey with heads of daycare facilities (or daycare staff responsible for the implementation of JolinchenKids), and III.) focus groups with daycare staff, children, and parents.
For this study, daycare facilities will be recruited nationwide. To answer research question a.), weight development, diet and physical activity behaviors and mental well-being of children at daycare facilities that started the program at the beginning of 2016 (“intervention daycare facilities”) will be compared to those at daycare facilities that will start the program at the end of 2017 (“waitlisted daycare facilities”). Target parameters will be assessed among children in both groups of daycare facilities at baseline and 12 months later. Additional assessments among parents and daycare staff are planned for both time points. To assess short-term effects of the intervention, anthropometric measures, physical activity (via parental reporting and triaxial accelerometers), motor skills, nutrition behavior (parental reporting), as well as psychological well-being (Kiddy-KINDL, SDQ) will be measured among children. In addition, health behaviors and literacy, as well as selected psychological variables (general self-efficacy, health-related quality of life, stress) will be assessed among daycare staff at baseline 12 months later. Staff at intervention daycare facilities will document intervention dose weekly during the 12-months implementation phase. The waitlisted control group receives the opportunity to implement the program after the follow-up assessment is completed.
To answer research questions b.) and c.), telephone interviews will be conducted with heads of daycare facilities and focus groups will be performed at intervention daycare facilities including heads of daycare facilities, daycare staff, children, and parents.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011065
  •   2016/09/16
  •   [---]*
  •   yes
  •   Approved
  •   522, Ethik-Kommission der Ärztekammer Bremen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Overweight, obesity, physical activity, balanced diet, mental well-being
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Arm 1: Intervention group: The program „JolinchenKids – Fit and healthy at daycare“ will be implemented at intervention daycare facilities. It is comprised of five modules: “diet”, “physical activity”, “mental well-being”, “parental participation” and “health of daycare staff” that can be chosen and implemented over the course of three years. Daycare staff receives training in the implementation of the program, as well as training and program materials. Representatives of the AOK health insurance in the respective regions support program implementation at the respective daycare facilities.
  •   Arm 2: Waitlisted control group: Receives the intervention after the assessment is completed at the intervention daycare facilities (12 months after baseline assessment).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Changes in body mass index and in percent body fat will be assessed with calibrated scales at baseline and 12 months later.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Changes in health behaviors (physical activity, diet) and mental well-being will be assessed at baseline and 12-months follow-up. Assessments include questionnaires on physical activity (e.g., BQHPA), dietary behavior, quality of life (Kiddy-KINDL, SF-12), self-efficacy (HAPA), health literacy (HLS-EU-16) and stress (PSS). In a subsample, physical activity will be assessed using triaxial accelerometers (GENEActiv, Activinsights, UK). Motor skill will be assessed using the Kindergarten Mobil-Test.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/07/20
  •   1020
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   5   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- informed consent of both parents/legal guardians regarding children’s participation in the study, informed consent of daycare staff to participate in the study
- children have to be supervised in kindergarten groups at the daycare facilities
- daycare facilities have to fulfill space requirements for performing the planned assessments
- only daycare facilities are included that supervise a minimum of 15 children aged 3-5 years

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

-daycare facilities without fixed kindergarten groups

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Leibniz-Institut Prävention und Epidemiologie - BIPS
    • Ms.  Prof. Dr.   Hajo  Zeeb 
    • Achterstr. 30
    • 28359  Bremen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPS
    • Ms.  PD Dr.  Claudia  Pischke 
    • Achterstr. 30
    • 28359  Bremen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Leibniz-Institut für Präventionsforschung und Epidemiologie
    • Ms.  Berit  Steenbock 
    • Achterstr. 30
    • 28359  Bremen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • AOK Bundesverband
    • Ms.  Dr.  Sarah  Pomp 
    • Rosenthaler Str. 31
    • 10178  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.