Family Meals on Prescription- a Randomized Controlled Trial

NCT05225350 | Completed

• 1 other identifier: 19002468
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood; Hypertension; Metabolic Syndrome; Dietary Habits

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Changes from Baseline in metabolic parameters at 12 months

  12 months after treatment intervention

• Experience of intervention with in 1 year after intervention

  with in 1 year after intervention

Study Arms (2)

Controls

NO INTERVENTION

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

Dietary Intervention

EXPERIMENTAL

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

Interventions

Dietary Intervention BEHAVIORAL

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

Dietary Intervention

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Younger than 5 or older than 15

Sponsors & Collaborators

• Göteborg University: lead
• Region Halland: collaborator

Study Sites (1)

Pediatric Clinic Region Halland

Halmstad, Halland County, 30233, Sweden

Location

Related Publications (2)

• Torstensson T, Almqvist-Tangen G, Waters S, Kindblom JM, Roswall J, Chaplin JE, Sjogren L. "The big win was that we actually cooked"- a qualitative interview study about the parental experience of Family Meals on Prescription for children living with obesity. J Health Popul Nutr. 2025 May 24;44(1):171. doi: 10.1186/s41043-025-00921-3.

  PMID: 40413511 DERIVED

• Torstensson T, Bohlin A, Almqvist-Tangen G, Roswall J, Kindblom JM, Sjogren L. Family meals on prescription as treatment for childhood obesity-a randomized controlled trial. Eur J Pediatr. 2024 Nov;183(11):4857-4866. doi: 10.1007/s00431-024-05744-8. Epub 2024 Sep 9.

  PMID: 39251447 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Hypertension; Metabolic Syndrome; Feeding Behavior

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Lovisa Sjogren, MD, PhD

  Goteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible children where randomized to 1 of 2 interventional arms.

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: February 4, 2022
• Study Start: February 1, 2019
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)