The Healthy School Start Plus Intervention Study

NCT03390725 | Completed

• 1 other identifier: KI 4-2891/2016
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention; Overweight and Obesity; Dietary Habits; Physical Activity; Parent-Child Relations

Keywords

Prevention, obesity, parenting, diet, physical activity

Outcome Measures

Primary Outcomes (2)

• Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume)

  Unhealthy foods: Sweets, ice cream, buns/cakes, crisps; Unhealthy drinks: Sugar-sweetened Beverages; Healthy Foods: Fruits and vegetables

  6 months post baseline

• Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume)

  Unhealthy foods: Sweets, ice cream, buns/cakes, crisps; Unhealthy drinks: Sugar-sweetened Beverages; Healthy Foods: Fruits and vegetables

  18 months post baseline

Secondary Outcomes (14)

• Total physical activity measured by accelerometry

  6 months post baseline

• Total physical activity measured by accelerometry

  18 months post baseline

• Moderate and vigorous physical activity measured by accelerometry

  6 months post baseline

• Moderate and vigorous physical activity measured by accelerometry

  18 months post baseline

• Vigorous physical activity measured by accelerometry

  6 months post baseline

Study Arms (2)

A Healthy School Start Plus intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

A Healthy School Start Plus intervention BEHAVIORAL

Intervention for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting

A Healthy School Start Plus intervention; Control

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child in pre-school class in schools in disadvantaged areas

You may not qualify if:

• None

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Kamprad Family Foundation for Entrepreneurship, Research & Charity: collaborator
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

Related Publications (5)

• Norman A, Malek ME, Nyberg G, Patterson E, Elinder LS. Effects of Universal School-Based Parental Support for Children's Healthy Diet and Physical Activity-the Healthy School Start Plus Cluster-Randomised Controlled Trial. Prev Sci. 2024 Aug;25(6):963-977. doi: 10.1007/s11121-024-01697-4. Epub 2024 Jul 11.

  PMID: 38987407 DERIVED

• Malek ME, Andermo S, Nyberg G, Elinder LS, Patterson E, Norman A. Parents' experiences of participating in the Healthy School Start Plus programme - a qualitative study. BMC Public Health. 2023 Apr 4;23(1):646. doi: 10.1186/s12889-023-15552-8.

  PMID: 37016372 DERIVED

• Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.

  PMID: 34555181 DERIVED

• Malek ME, Nyberg G, Elinder LS, Patterson E, Norman A. Children's experiences of participating in a school-based health promotion parental support programme - a qualitative study. BMC Pediatr. 2021 May 11;21(1):228. doi: 10.1186/s12887-021-02694-0.

  PMID: 33975569 DERIVED

• Elinder LS, Patterson E, Nyberg G, Norman A. A Healthy School Start Plus for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting - study protocol for a parallel group cluster randomised trial. BMC Public Health. 2018 Apr 6;18(1):459. doi: 10.1186/s12889-018-5354-4.

  PMID: 29625599 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Feeding Behavior; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Liselotte S Elinder, professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 4, 2018
• Study Start: June 1, 2017
• Primary Completion: June 20, 2019
• Study Completion: December 31, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)