Effectiveness of a Family Support Model for Prevention and Management of Overweight and Obesity in Children 6-12 Years (Co-Fam)

Karolinska Institute

Status: Not yet enrolling

Conditions: Obesity &Amp; Overweight

Treatments: Behavioral: More and Less

Study type: Interventional

Funder types: Other

Identifiers

NCT07158944

20230923 (Other Grant/Funding Number)

2025-01385-01

2024-02536 (Other Grant/Funding Number)

20250603 (Other Grant/Funding Number)

Details and patient eligibility

About

The study will evaluate a coherent model of family support including school health care, primary health care and pediatric clinics. The model combines two evidence based programs: the universal "A Healthy School Start" provided to all children and their families during grade 1 and the targeted parental support program "More and Less" provided to parents of children with overweight or obesity.

The hypothesis is that combining the Healthy School Start and More and Less programs in a coherent model will increase the collaboration between regional and municipal stakeholders, ensure early identification of families in need, ultimately improving prevention and treatment of childhood overweight and obesity. The aim of this study is to evaluate the implementation of a coherent model of family support provided through school and primary health care.

Full description

In this hybrid type 2 effectiveness-implementation study, a two-armed randomized controlled trial will randomize families to either the intervention arm receiving the More and Less program or the control arm receiving standard care from primary health care or a pediatric clinic. A matched control group will be identified from a national obesity register for supplementary comparison. Eligible participants are families with children aged 6-12 years with overweight or obesity, enrolled in schools implementing the Healthy School Start program. Effectiveness outcomes to evaluate the intervention are BMI z-score, parental feeding practices, diet and physical activity, child eating behaviour and intervention fidelity which will be measured at baseline, three and 12 months. Implementation outcomes will be evaluated in a process evaluation assessing reach, fidelity, acceptability, feasibility and cost, assessed at 12 and 24 months using a mixed methods approach.

Enrollment: 126 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A parent of a child between 6-12 years of age.
• The child attends a school providing the Healthy School Start program.
• The child has been diagnosed with overweight (age standardized BMI of 25 or above) or obesity (age standardized BMI of 30 or above) by a health care personnel.

Exclusion criteria

- If parents are unable to understand and/or communicate in easy Swedish.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Intervention

Experimental group

Description:

Receives A Healthy School Start and the More and Less program

Treatment:

Behavioral: More and Less

Control

No Intervention group

Description:

Receives A Healthy School Start and standard treatment for overweight or obesity