Family Meals on Prescription- a Randomized Controlled Trial

Hypertension Clinical Trial

Official title:

Matkassen-effekter av 3 månaders Intensiv Kostintervention Riktad Till Barn Med Fetma / Family Meals on Prescription- a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225350
• Other study ID #: 19002468
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: September 29, 2020

Study information

• Verified date: June 2022
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 29, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Habits
• Hypertension
• Metabolic Syndrome
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Dietary Intervention
See previous text Dietary intervention consisiting och each family recieving foodpackages for 5 dinner meals during three months.

Locations

Country	Name	City	State
Sweden	Pediatric Clinic Region Halland	Halmstad	Halland

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Region Halland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline in Dietary habits at one year	Assessment of meal pattern and dietary composition through questionaire.	1 year
Primary	Changes from Baseline in BMI at 3 months	Changes in BMI SDS in the different intervention groups	3 months
Primary	Changes from Baseline in BMI at 12 months	Changes in BMI SDS in the different intervention groups	12 months
Primary	Changes from Baseline in BMI at 18 months	Changes in BMI SDS in the different intervention groups	18 months
Primary	Changes from Baseline in BMI at 24 months	Changes in BMI SDS in the different intervention groups	24 months
Secondary	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	12 months after treatment intervention
Secondary	Experience of intervention with in 1 year after intervention	Qualitative investigation through interviews and analysis from statements in medical journal	with in 1 year after intervention