AzTrials
AzTrials

Obesity &Amp; OverweightCo-FamNCT07158944

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

A study testing More and Less in people with Obesity &Amp; Overweight, run by Karolinska Institutet at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Obesity &Amp; Overweight
What is being tested?
More and Less
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteSweden
Study dates
Sep 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ida E Karlsson, PhD contact

0738-386516 ext. 0046

ida.karlsson.1@ki.se

Kristi S Annerstedt, Ass Professor contact

0709202081 ext. 0046

kristi.sidney@ki.se

Sweden1 site

  • Primary healthcare

    Södertälje

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
More and Less
Keywords
Prevention, Obesity treatment, Parental support, Children
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • More and LessBehavioural

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

Study groups in NCT07158944
Study groupRoleWhat they receive
InterventionExperimentalReceives A Healthy School Start and the More and Less program
Receives: Behavioral: More and Less
ControlNo interventionReceives A Healthy School Start and standard treatment for overweight or obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured at baseline, 3 and 12 months.

Secondary outcomes (4)

  1. The child's dietary habits

    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.

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

  2. The child's physical activity level

    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.

    Measured: Measured at baseline, 3 and 12 months

  3. The child's eating behavior

    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)

    Measured: Measured at baseline, 3 and 12 months

  4. Parental feeding practices

    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).

    Measured: Measured at baseline, 3 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158944
Sponsor's protocol ID
2025-01385-01
Other IDs
2024-02536, 20230923, 20250603, 2025
Acronym
Co-Fam
Status last verified
Aug 2025
First submitted
19 Aug 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will not be publicly available due to containing information that could compromise the privacy of the study participants.

Publications

  • Berdman I, Ek A, Nowicka P, Raposo S, Kwak L, Brissman M, Andermo S, Annerstedt KS, Elinder LS. A coherent family support model (Co-Fam) for preventing and treating childhood overweight and obesity: protocol for a randomized hybrid type 2 effectiveness-implementation trial. BMC Public Health. 2026 Sep 21;26(1):2636. doi: 10.1186/s12889-026-29530-3.

    PubMed 42768347

Questions about this trial

What is this clinical trial studying?

A study testing More and Less in people with Obesity &Amp; Overweight, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ida E Karlsson, PhD (0738-386516 ext. 0046, ida.karlsson.1@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI z-score (time frame: Measured at baseline, 3 and 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07158944, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in