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Family Meals on Prescription- a Randomized Controlled Trial

Primary Purpose

Obesity, Childhood, Hypertension, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Dietary Intervention

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pediatric Clinic Region Halland

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Controls

Dietary Intervention

Arm Description

In the first arm the patients received care consistent with regional guidelines. Treatment as usual.

In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months

Outcomes

Primary Outcome Measures

Changes from Baseline in Dietary habits at one year

Assessment of meal pattern and dietary composition through questionaire.

Changes from Baseline in BMI at 3 months

Changes in BMI SDS in the different intervention groups

Changes from Baseline in BMI at 12 months

Changes in BMI SDS in the different intervention groups

Changes from Baseline in BMI at 18 months

Changes in BMI SDS in the different intervention groups

Changes from Baseline in BMI at 24 months

Changes in BMI SDS in the different intervention groups

Secondary Outcome Measures

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

Experience of intervention with in 1 year after intervention

Qualitative investigation through interviews and analysis from statements in medical journal

Full Information

NCT ID

NCT05225350

First Posted

November 27, 2020

Last Updated

June 29, 2022

Sponsor

Göteborg University

Collaborators

Region Halland

1. Study Identification

Unique Protocol Identification Number

NCT05225350

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

September 29, 2020 (Actual)

Study Completion Date

September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Göteborg University

Collaborators

Region Halland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Childhood, Hypertension, Metabolic Syndrome, Dietary Habits

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Eligible children where randomized to 1 of 2 interventional arms.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Controls

Arm Type

No Intervention

Arm Description

In the first arm the patients received care consistent with regional guidelines. Treatment as usual.

Arm Title

Dietary Intervention

Arm Type

Experimental

Arm Description

In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months

Intervention Type

Behavioral

Intervention Name(s)

Dietary Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes from Baseline in Dietary habits at one year

Description

Assessment of meal pattern and dietary composition through questionaire.

Time Frame

1 year

Title

Changes from Baseline in BMI at 3 months

Description

Changes in BMI SDS in the different intervention groups

Time Frame

3 months

Title

Changes from Baseline in BMI at 12 months

Description

Changes in BMI SDS in the different intervention groups

Time Frame

12 months

Title

Changes from Baseline in BMI at 18 months

Description

Changes in BMI SDS in the different intervention groups

Time Frame

18 months

Title

Changes from Baseline in BMI at 24 months

Description

Changes in BMI SDS in the different intervention groups

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Changes from Baseline in metabolic parameters at 12 months

Description

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

Time Frame

12 months after treatment intervention

Title

Experience of intervention with in 1 year after intervention

Description

Qualitative investigation through interviews and analysis from statements in medical journal

Time Frame

with in 1 year after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lovisa Sjogren, MD, PhD

Organizational Affiliation

Goteborg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pediatric Clinic Region Halland

City

Halmstad

State/Province

Halland

ZIP/Postal Code

30233

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Family Meals on Prescription- a Randomized Controlled Trial

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