Family Intervention for Treatment of Obesity With Digi-physical Support

NCT06236906 | Unknown

• 1 other identifier: FamEv2024
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obesity in childhood is a global public health problem which continues to increase. It is associated with type 2 diabetes, high blood pressure, certain types of cancer, decreased psycho-social health and early mortality, among many other short- and long-term consequences. In many families where a child has obesity, at least one parent also has obesity or overweight with co-morbidity. In many cases, the care for children is more structured than for adults. Family treatment aimed at making lifestyle changes for the entire family, with those with obesity also restricting their calorie intake to normalize weight, has not been tested in Sweden and on a very limited scale internationally. International studies have shown that the more frequent the contact with healthcare, the better the results, regardless of the treatment method. However, frequent contacts are challenging to implement due to significant demands on both families and healthcare. To address these challenges, the investigators aim to facilitate, improve, and optimize healthcare using a digital treatment support system involving daily home weighing and electronic communication between the clinic and families via a mobile application. The system is unique as it is based on real measurements, allowing both families and clinical staff to continuously monitor weight changes. This treatment involves fewer physical visits to the clinic but more frequent contact through the digital support system. The goal is to evaluate whether a digital-physical family treatment conducted in primary care for families with at least one adult and one child with obesity leads to sustained weight loss with fewer visits, fewer missed appointments, resulting in more cost-effective care.

Conditions

Childhood Obesity; mHealth; Personalized Medicine

Keywords

Obesity treatment; Digital support system

Outcome Measures

Primary Outcomes (1)

• Families and practitioners experience of the treatment

  Evaluate the experience from both families and practitioners regarding the treatment of the child and parent together with the support of the digital support system. Evira specific questionnaires.

  Baseline, and at three and six months follow-up.

Secondary Outcomes (6)

• Families adherence to treatment

  Trough study completion, an average of six months.

• Families adherence in the use of the digital support system

  Trough study completion, an average of six months.

• 36-Item Short Form Survey (SF-36) for parents

  Trough study completion, an average of six months.

• Pediatric Quality of Life Inventory 4.0 for children (PedsQL)

  Trough study completion, an average of six months.

• Participants', the children and parents psycho-social health during the family treatment

  Trough study completion, an average of six months.

Study Arms (1)

Intervention

EXPERIMENTAL

Child and parent in digi-physical family treatment

Device: Device supported behavioural treatment

Interventions

Device supported behavioural treatment DEVICE

The method involves behavioral change supported by a digital support system, including daily home weighings, a clear weight curve in a mobile app, and communication with the treatment team through the same app.

Also known as: Evira

Intervention

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• One or more children with obesity. Obesity defined based on the International Task Force criteria iso-BMI 30 and 35.
• At least one parent with obesity, i.e., BMI \>30, or overweight with risk factors or comorbidity with a desire and willingness to lose weight.

You may not qualify if:

• Mental or physical illness in the child or parent that could seriously complicate the study's implementation.
• Serious language barriers preventing written communication in the digital support system.
• Separated parents where collaboration problems may complicate the study's implementation.
• Other reasons assessed to seriously complicate the study's implementation.

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (2)

• Johansson L, Hagman E, Danielsson P. A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. BMC Pediatr. 2020 Sep 23;20(1):447. doi: 10.1186/s12887-020-02338-9.

  PMID: 32967638 BACKGROUND

• Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31.

  PMID: 35641569 BACKGROUND

Related Links

• Evira homepage

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pernilla Danielsson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernilla Danielsson, PhD

CONTACT

+46 708377734; pernilla.danielsson-liljeqvist@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share