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Family Intervention for Treatment of Obesity With Digi-physical Support

NCT06236906 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-02-01

No results posted yet for this study

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

Interventions

DEVICE

Device supported behavioural treatment

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.

Sponsors & Collaborators

Principal Investigators

  • Pernilla Danielsson, PhD · Karolinska Institutet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-12-20
Completion
2024-12-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06236906 on ClinicalTrials.gov