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Trial record 1 of 1 for:    03390725
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The Healthy School Start Plus Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390725
Recruitment Status : Active, not recruiting
First Posted : January 4, 2018
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Swedish research council for health, working life and welfare
Information provided by (Responsible Party):
Liselotte Schäfer Elinder, Karolinska Institutet

Brief Summary:
The proposed study is a cluster randomized trial to test the effectiveness of a parental support programme in pre-school class to promote healthy dietary habits and physical activity and prevent obesity, delivered by teachers and school health services and in collaboration with primary care. The control condition is standard care in schools. The 6-month programme is carried out in schools in disadvantaged areas and is universal. It is based on Social Cognitive Theory and consists of four components: 1) Health information to parents regarding the child; 2) Motivational Interviewing with the parents by the school nurse concerning the child; 3) classroom activities for the children with home assignments; and 4) a web-based self-test of type-2 diabetes risk by parents, with follow-up in primary health care. The primary outcome is assessed as the difference between the intervention and the control group directly after the end of intervention at 6-months post baseline, and at follow-up 18 months post baseline, adjusted for baseline values. The outcome variables are the intake of unhealthy foods, unhealthy drinks, and healthy foods assessed by a newly developed method using photo-based dietary assessment. The secondary outcomes are physical activity and time spent sedentary measured by accelerometry, and measured BMI and waist circumference. Hypothetical mediator variables are parental self-efficacy and parenting practices regarding diet and physical activity assessed by questionnaire. Process evaluation will be performed through interviews and questionnaires to study how well the programme was implemented in terms of dose, fidelity, acceptability and feasibility. The programme is in line with the latest evidence regarding the prevention of childhood obesity: that schools should be a focal point of prevention efforts, interventions should involve multiple components, and include the home environment. If effective, it will fill a large knowledge gap concerning evidence-based health promotion practice within school health services to prevent overweight and obesity and in the long term reduce social inequalities in health.

Condition or disease Intervention/treatment Phase
Prevention Overweight and Obesity Dietary Habits Physical Activity Parent-Child Relations Behavioral: A Healthy School Start Plus intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Healthy School Start Plus Intervention for Prevention of Childhood Overweight and Obesity in Disadvantaged Areas Through Parental Support in the School Setting - a Parallel Group Cluster Randomised Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 20, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: A Healthy School Start Plus intervention
The intervention consists of 4 components given to all participants in the experimental group: 1) A health information brochure regarding child's health; 2) Motivational Interviewing with the parents by the school nurse concerning the child; 3) classroom activities for the children with home assignments; and 4) a web-based self-test of type-2 diabetes risk by parents with recommendation to contact primary health care in case of elevated risk.
Behavioral: A Healthy School Start Plus intervention
Intervention for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting

Active Comparator: Control
Treatment as usual in school health services plus the health information brochure regarding child's health (component 1 of the intervention)
Behavioral: A Healthy School Start Plus intervention
Intervention for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting




Primary Outcome Measures :
  1. Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) [ Time Frame: 6 months post baseline ]
    Unhealthy foods: Sweets, ice cream, buns/cakes, crisps; Unhealthy drinks: Sugar-sweetened Beverages; Healthy Foods: Fruits and vegetables

  2. Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) [ Time Frame: 18 months post baseline ]
    Unhealthy foods: Sweets, ice cream, buns/cakes, crisps; Unhealthy drinks: Sugar-sweetened Beverages; Healthy Foods: Fruits and vegetables


Secondary Outcome Measures :
  1. Total physical activity measured by accelerometry [ Time Frame: 6 months post baseline ]
    Total physical activity (cpm)

  2. Total physical activity measured by accelerometry [ Time Frame: 18 months post baseline ]
    Total physical activity (cpm)

  3. Moderate and vigorous physical activity measured by accelerometry [ Time Frame: 6 months post baseline ]
    Time in intensity >2296 cpm

  4. Moderate and vigorous physical activity measured by accelerometry [ Time Frame: 18 months post baseline ]
    Time in intensity >2296 cpm

  5. Vigorous physical activity measured by accelerometry [ Time Frame: 6 months post baseline ]
    Time in intensity >4012 cpm

  6. Vigorous physical activity measured by accelerometry [ Time Frame: 18 months post baseline ]
    Time in intensity >4012 cpm

  7. Sedentary behaviour measured by accelerometry [ Time Frame: 6 months post baseline ]
    Time in intensity <100 cpm

  8. Sedentary behaviour measured by accelerometry [ Time Frame: 18 months post baseline ]
    Time in intensity <100 cpm

  9. BMI standard deviation score [ Time Frame: 6 months post baseline ]
    According to International Obesity Task Force (IOTF)

  10. BMI standard deviation score [ Time Frame: 18 months post baseline ]
    According to International Obesity Task Force (IOTF)

  11. Weight status [ Time Frame: 6 months post baseline ]
    Proportion of children with underweight + normal weight, overweight and obesity according to International Obesity Task Force (IOTF)

  12. Weight status [ Time Frame: 18 months post baseline ]
    Proportion of children with underweight + normal weight, overweight and obesity according to International Obesity Task Force (IOTF)

  13. Waist circumference [ Time Frame: 6 months post baseline ]
    Measured waist circumference

  14. Waist circumference [ Time Frame: 18 months post baseline ]
    Measured waist circumference



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Child in pre-school class in schools in disadvantaged areas

Exclusion Criteria:

None


Information from the National Library of Medicine

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): NCT03390725


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Swedish research council for health, working life and welfare
Investigators
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Principal Investigator: Liselotte S Elinder, professor Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liselotte Schäfer Elinder, professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03390725    
Other Study ID Numbers: KI 4-2891/2016
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liselotte Schäfer Elinder, Karolinska Institutet:
Prevention, obesity, parenting, diet, physical activity
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms