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NCT Number: NCT07158944

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

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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Key information

Conditions

Obesity &Amp; Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary healthcare

Södertälje, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. BMI z-score

    Time frame: Measured at baseline, 3 and 12 months.

    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

Secondary outcomes

  1. The child's dietary habits

    Time frame: Measured at baseline, 3 and 12 months follow-up

    Assessed using the Eating and Physical Activity Questionnaire (EPAQ).

    Parents are asked to recall the child's intake of unhealthy and healthy foods and unhealthy drinks. Questions are answered as amounts (deciliters, glasses or portions) of 0 to 7 or more. For unhealthy foods - higher numbers are worse, for healthy foods - higher numbers are better.

  2. The child's physical activity level

    Time frame: Measured at baseline, 3 and 12 months

    Assessed through three questions from the Public Health Agency's annual school survey to children, with questions asked to the parents.

    Questions are answered by estimating the number of days a week with physical activity (0-7), number of times a week with exercise (0-7) and time spent sedentary during the week (0-5) - higher numbers are better.

  3. The child's eating behavior

    Time frame: Measured at baseline, 3 and 12 months

    Assessed using the validated Children's Eating Behavior Questionnaire (CEBQ) including 35 questions on eight different scales that help identify behavioral traits that may contribute to obesity or disordered eating and is answered by a parent.

    Answers: Parents rate their child's eating behavior on a five-point Likert scale (never, rarely, sometimes, often, always)

  4. Parental feeding practices

    Time frame: Measured at baseline, 3 and 12 months

    Assessed using the validated Comprehensive Parental Feeding Questionnaire (CPFQ) including five factors: Monitoring of children's food intake, pressure to eat, restriction of food, use of food for emotional regulation, and healthy eating guidance.

    Answers: parents rate their feeding practices on a four-point Likert scale (rarely, sometimes, often, very often) or (disagree, somewhat disagree, somewhat agree, agree).

Study contacts

Contact information is provided by the study sponsor or research team.

Ida E Karlsson, PhD

CONTACT

[email protected]

0738-386516 ext. 0046

Kristi S Annerstedt, Ass Professor

CONTACT

[email protected]

0709202081 ext. 0046

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: Co-Fam

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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