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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity &Amp; Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A hybrid type 2 effectiveness-implementation study will evaluate the effectiveness through a randomized controlled trial with two parallel arms and the implementation through a process evaluation. In addition, a register based control group receiving standard treatment will be collected retrospectively to allow for a national comparison.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Receives A Healthy School Start and the More and Less program

Group Type EXPERIMENTAL

More and Less

Intervention Type BEHAVIORAL

Dose: 10 group sessions + 6 individual booster sessions Frequency: 10 weekly group sessions (10 weeks) 6 booster sessions every 6th week

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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More and Less

Dose: 10 group sessions + 6 individual booster sessions Frequency: 10 weekly group sessions (10 weeks) 6 booster sessions every 6th week

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.