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Completed

NCT Number: NCT05225350

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.

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Key information

Conditions

Obesity, Childhood Behavior Behavior, Animal Body Weight Cardiovascular Diseases Dietary Habits Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Vascular Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Clinic Region Halland

Halmstad, Halland County, 30233, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention

Behavioral

See previous text

Dietary intervention consisiting och each family recieving foodpackages for 5 dinner meals during three months.

Primary outcomes

  1. Changes from Baseline in Dietary habits at one year

    Time frame: 1 year

    Assessment of meal pattern and dietary composition through questionaire.

  2. Changes from Baseline in BMI at 3 months

    Time frame: 3 months

    Changes in BMI SDS in the different intervention groups

  3. Changes from Baseline in BMI at 12 months

    Time frame: 12 months

    Changes in BMI SDS in the different intervention groups

  4. Changes from Baseline in BMI at 18 months

    Time frame: 18 months

    Changes in BMI SDS in the different intervention groups

  5. Changes from Baseline in BMI at 24 months

    Time frame: 24 months

    Changes in BMI SDS in the different intervention groups

Secondary outcomes

  1. Changes from Baseline in metabolic parameters at 12 months

    Time frame: 12 months after treatment intervention

    Glucose control (fP-Glc, fs-Insulin, HbA1c,), Blood lipids (HDL, LDL, TG,), (liver function tests (, ALT, ) Vitamin D

  2. Experience of intervention with in 1 year after intervention

    Time frame: with in 1 year after intervention

    Qualitative investigation through interviews and analysis from statements in medical journal

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Region Halland

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2022
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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