Family Meals on Prescription- a Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Childhood, Hypertension, Metabolic Syndrome, Dietary Habits

Intervention / Treatment
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* Behavioral: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible children where randomized to 1 of 2 interventional arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Controls<br>In the first arm the patients received care consistent with regional guidelines. Treatment as usual. | |
| Experimental: Dietary Intervention<br>In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months | Behavioral: Dietary Intervention<br>* See previous text Dietary intervention consisiting och each family recieving foodpackages for 5 dinner meals during three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in Dietary habits at one year | Assessment of meal pattern and dietary composition through questionaire. | 1 year | 
| Changes from Baseline in BMI at 3 months | Changes in BMI SDS in the different intervention groups | 3 months | 
| Changes from Baseline in BMI at 12 months | Changes in BMI SDS in the different intervention groups | 12 months | 
| Changes from Baseline in BMI at 18 months | Changes in BMI SDS in the different intervention groups | 18 months | 
| Changes from Baseline in BMI at 24 months | Changes in BMI SDS in the different intervention groups | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |