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Digital-Physical Family Intervention in Primary Care for Families With Obesity in Both Children and Adults
Sponsor study identifier
interventional
12
0 countries
N/A
Study Start
February 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2023
Actual (reported)February 1, 2024
Actual (reported)February 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
Child and parent in digi-physical family 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
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.
Pernilla Danielsson, PhD
Karolinska Institutet
First Submitted
December 20, 2023
First Posted
February 1, 2024
Study Start
February 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 20, 2024
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 1, 2024
Record last verified: 2024-01
Using the evaluation from this study, we aim to optimize the family treatment method and finalize the application design based on user experiences for a larger randomized trial. as there are few individuals from a small place in Sweden, it will be difficult to keep the data anonymous.
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Source: ClinicalTrials.gov.
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