Clinical trial NCT05225350: Family Meals on Prescription- a Randomized Controlled Trial
Official title: Matkassen-effekter av 3 månaders Intensiv Kostintervention Riktad Till Barn Med Fetma / Family Meals on Prescription- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Hypertension
Metabolic Syndrome
Dietary Habits
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Region Halland
First posted: 2022-02-04
Enrollment: 89
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible children where randomized to 1 of 2 interventional arms.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 5 to 15
* attending the Paediatric Obesity Clinics in Kungsbacka or Varberg

Exclusion Criteria:

* Younger than 5 or older than 15

Primary outcomes:
measure: Changes from Baseline in Dietary habits at one year
timeFrame: 1 year
measure: Changes from Baseline in BMI at 3 months
timeFrame: 3 months
measure: Changes from Baseline in BMI at 12 months
timeFrame: 12 months
measure: Changes from Baseline in BMI at 18 months
timeFrame: 18 months
measure: Changes from Baseline in BMI at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Changes from Baseline in metabolic parameters at 12 months
timeFrame: 12 months after treatment intervention
measure: Experience of intervention with in 1 year after intervention
timeFrame: with in 1 year after intervention
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Pediatric Clinic Region Halland
state: Halland
Study officials:
affiliation: Goteborg University
name: Lovisa Sjogren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: