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

NCT07158944 | Not Yet Recruiting

• 4 other identifiers: 2025-01385-012024-025362023092320250603
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity &Amp; Overweight

Keywords

Prevention; Obesity treatment; Parental support; Children

Outcome Measures

Primary Outcomes (1)

• BMI z-score

  The effects on children's BMI z-score (IOTF cut offs) whose parents receive the More and Less program over a 12-month period, compared to children receiving standard treatment

  Measured at baseline, 3 and 12 months.

Secondary Outcomes (4)

• The child's dietary habits

  Measured at baseline, 3 and 12 months follow-up

• The child's physical activity level

  Measured at baseline, 3 and 12 months

• The child's eating behavior

  Measured at baseline, 3 and 12 months

• Parental feeding practices

  Measured at baseline, 3 and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Receives A Healthy School Start and the More and Less program

Behavioral: More and Less

Control

NO INTERVENTION

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

Interventions

More and Less BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Primary healthcare

Södertälje, Sweden

Location

Related Links

• Information about the Co-fam study

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Liselotte S Elinder, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida E Karlsson, PhD

CONTACT

0738-386516; ida.karlsson.1@ki.se

Kristi S Annerstedt, Ass Professor

CONTACT

0709202081; kristi.sidney@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)