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

Official title

A Coherent Family Support Model (Co-Fam) for Prevention and Management of Childhood Obesity: Protocol for a Hybrid Type 2 Effectiveness-implementation Trial

Overview

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.

Detailed 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.

Interventions

• Behavioral More and Less
  Dose: 10 group sessions + 6 individual booster sessions Frequency: 10 weekly group sessions (10 weeks) 6 booster sessions every 6th week

Primary outcome measures

• BMI z-score [Time frame: Measured at baseline, 3 and 12 months.]

Secondary outcome measures (4)

• The child's dietary habits [Time frame: Measured at baseline, 3 and 12 months follow-up]
• The child's physical activity level [Time frame: Measured at baseline, 3 and 12 months]
• The child's eating behavior [Time frame: Measured at baseline, 3 and 12 months]
• Parental feeding practices [Time frame: Measured at baseline, 3 and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Primary healthcare — Södertälje

Identifiers

NCT: NCT07158944 · 2025-01385-01 · 2024-02536 · 20230923 · 20250603

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗