Obesity, ChildhoodNCT05225350
Family Meals on Prescription- a Randomized Controlled Trial
A study testing Dietary Intervention in people with Obesity, Childhood and Hypertension, run by Göteborg University at 1 site in Sweden.
Trial summary
"Matkassen - effekten av tre månaders intensiv kostintervention hos barn med fetma/ Family Meals on Prescription.- a randomized controlled trial : The aim of the study was to explore a novel approach for the treatment of obesity in children and adolescents through an intensive dietary intervention, consisting of… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Obesity, Childhood, Hypertension, Metabolic Syndrome
- What is being tested?
- Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2019to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 5 to 15
- attending the Paediatric Obesity Clinics in Kungsbacka or Varberg
Who cannot join
- Younger than 5 or older than 15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Matkassen-effekter av 3 månaders Intensiv Kostintervention Riktad Till Barn Med Fetma / Family Meals on Prescription- a Randomized Controlled Trial
"Matkassen - effekten av tre månaders intensiv kostintervention hos barn med fetma/ Family Meals on Prescription.- a randomized controlled trial : The aim of the study was to explore a novel approach for the treatment of obesity in children and adolescents through an intensive dietary intervention, consisting of receiving a weekly bag of groceries and recipes for five family meals at a reduced price for three months.
Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.
Read the detailed description
Children between the age of 5-15 years receiving treatment for obesity at the pediatric clinics in Varberg and Kungsbacka were offered to participate in the trial.
The study population was divided into two arms including 60 patients in each arm:
- In the first arm the patients received care consistent with regional guidelines.
- In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months.
Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.
- Conditions
- Obesity, Childhood, Hypertension, Metabolic Syndrome, Dietary Habits
- Being tested
- Dietary Intervention
- Medical subject headings
- Pediatric Obesity, Hypertension, Metabolic Syndrome, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
See previous text
Dietary intervention consisiting och each family recieving foodpackages for 5 dinner meals during three months.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | In the first arm the patients received care consistent with regional guidelines. Treatment as usual. |
| Dietary Intervention | Experimental | In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months Receives: Behavioral: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in Dietary habits at one year
Assessment of meal pattern and dietary composition through questionaire.
Measured: 1 year
Changes from Baseline in BMI at 3 months
Changes in BMI SDS in the different intervention groups
Measured: 3 months
Changes from Baseline in BMI at 12 months
Changes in BMI SDS in the different intervention groups
Measured: 12 months
Changes from Baseline in BMI at 18 months
Changes in BMI SDS in the different intervention groups
Measured: 18 months
Changes from Baseline in BMI at 24 months
Changes in BMI SDS in the different intervention groups
Measured: 24 months
Secondary outcomes (2)
Changes from Baseline in metabolic parameters at 12 months
Glucose control (fP-Glc, fs-Insulin, HbA1c,), Blood lipids (HDL, LDL, TG,), (liver function tests (, ALT, ) Vitamin D
Measured: 12 months after treatment intervention
Experience of intervention with in 1 year after intervention
Qualitative investigation through interviews and analysis from statements in medical journal
Measured: with in 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Feb 2019
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Eligible children where randomized to 1 of 2 interventional arms.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Halland
- Responsible party
- Sponsor
- Investigators
- Lovisa Sjogren, MD, PhD, Principal investigator, Goteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225350
- Sponsor's protocol ID
- 19002468
- Status last verified
- Jun 2022
- First submitted
- 27 Nov 2020
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torstensson T, Almqvist-Tangen G, Waters S, Kindblom JM, Roswall J, Chaplin JE, Sjogren L. "The big win was that we actually cooked"- a qualitative interview study about the parental experience of Family Meals on Prescription for children living with obesity. J Health Popul Nutr. 2025 May 24;44(1):171. doi: 10.1186/s41043-025-00921-3.
PubMed 40413511Torstensson T, Bohlin A, Almqvist-Tangen G, Roswall J, Kindblom JM, Sjogren L. Family meals on prescription as treatment for childhood obesity-a randomized controlled trial. Eur J Pediatr. 2024 Nov;183(11):4857-4866. doi: 10.1007/s00431-024-05744-8. Epub 2024 Sep 9.
PubMed 39251447
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matkassen-effekter av 3 månaders Intensiv Kostintervention Riktad Till Barn Med Fetma / Family Meals on Prescription- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05225350
- Acronym / sponsor ID
- 19002468
- Conditions
- Obesity, Childhood, Hypertension, Metabolic Syndrome, Dietary Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Region Halland
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Matkassen - effekten av tre månaders intensiv kostintervention hos barn med fetma/ Family Meals on Prescription.- a randomized controlled trial : The aim of the study was to explore a novel approach for the treatment of obesity in children and adolescents through an intensive dietary intervention, consisting of receiving a weekly bag of groceries and recipes for five family meals at a reduced price for three months.
Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.
Detailed description
Children between the age of 5-15 years receiving treatment for obesity at the pediatric clinics in Varberg and Kungsbacka were offered to participate in the trial.
The study population was divided into two arms including 60 patients in each arm:
- In the first arm the patients received care consistent with regional guidelines.
- In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months.
Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible children where randomized to 1 of 2 interventional arms.
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –In the first arm the patients received care consistent with regional guidelines. Treatment as usual. |
| Dietary Intervention | Experimental | Behavioral: Dietary InterventionIn the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children between the ages of 5 to 15
- attending the Paediatric Obesity Clinics in Kungsbacka or Varberg
Key exclusion criteria (1 listed)
- Younger than 5 or older than 15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionSee previous text Dietary intervention consisiting och each family recieving foodpackages for 5 dinner meals during three months. | Behavioural | Dietary Intervention |
Primary outcome
Changes from Baseline in Dietary habits at one year
Time frame: 1 year
Assessment of meal pattern and dietary composition through questionaire.
Changes from Baseline in BMI at 3 months
Time frame: 3 months
Changes in BMI SDS in the different intervention groups
Changes from Baseline in BMI at 12 months
Time frame: 12 months
Changes in BMI SDS in the different intervention groups
Changes from Baseline in BMI at 18 months
Time frame: 18 months
Changes in BMI SDS in the different intervention groups
Changes from Baseline in BMI at 24 months
Time frame: 24 months
Changes in BMI SDS in the different intervention groups
2 secondary outcomes
Changes from Baseline in metabolic parameters at 12 months
Time frame: 12 months after treatment intervention
Experience of intervention with in 1 year after intervention
Time frame: with in 1 year after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 40413511Torstensson T, Almqvist-Tangen G, Waters S, Kindblom JM, Roswall J, Chaplin JE, Sjogren L. "The big win was that we actually cooked"- a qualitative interview study about the parental experience of Family Meals on Prescription for children living with obesity. J Health Popul Nutr. 2025 May 24;44(1):171. doi: 10.1186/s41043-025-00921-3.
- Derived from this study: PubMed 39251447Torstensson T, Bohlin A, Almqvist-Tangen G, Roswall J, Kindblom JM, Sjogren L. Family meals on prescription as treatment for childhood obesity-a randomized controlled trial. Eur J Pediatr. 2024 Nov;183(11):4857-4866. doi: 10.1007/s00431-024-05744-8. Epub 2024 Sep 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lovisa Sjogren, MD, PhD principal investigator
Goteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Obesity, Childhood and Hypertension, run by Göteborg University 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 2 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: finished, as of the sponsor's last update on 30 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in Dietary habits at one year (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT05225350, which also lists 2 linked publications.
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 30 Jun 2022.