Family Intervention for Treatment of Obesity With Digi-physical Support

January 31, 2024 updated by: Pernilla Danielsson, Karolinska Institutet

Digital-Physical Family Intervention in Primary Care for Families With Obesity in Both Children and Adults

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators have evaluated a digital support system for childhood obesity. The result shows twice as good results for the children who used the system compared to a control group treated with usual care despite a low frequency of physical clinical visits.

The method involves behavioral change supported by a digital support system, including daily home weighing, a clear weight curve in a mobile app, and communication with the treatment team through the same app. Working with the support system means that, as a caregiver, one follows a clear manual. The core idea is that families, using a partially Motivational Interviewing-based communication approach, find their own ways to reduce excess weight in accordance with what the mobile app indicates. The healthcare provider offers information as needed but refrains from providing specific advice. Instead, the provider supports how to manage the changes. Treatment focuses on the parental role, setting boundaries, collaboration, conflict resolution, and avoiding self-deception.

Over six months, 8-12 families will undergo Family Treatment within primary care. The goal is to evaluate the treatment's effectiveness based on experiences from both families and caregivers, using surveys and semi-structured interviews after three and six months.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Child and parent in digi-physical family treatment
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.
Other Names:
  • Evira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Families and practitioners experience of the treatment
Time Frame: Baseline, and at three and six months follow-up.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Families adherence to treatment
Time Frame: Trough study completion, an average of six months.
Number of physical appointments, cancellations, and missed visits.
Trough study completion, an average of six months.
Families adherence in the use of the digital support system
Time Frame: Trough study completion, an average of six months.
Frequency of Evira weighings, written and received messages
Trough study completion, an average of six months.
36-Item Short Form Survey (SF-36) for parents
Time Frame: Trough study completion, an average of six months.
Questionnaires regarding quality of life. 36-Item Short Form Survey (SF-36) for parents. SF-36 cover eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state.
Trough study completion, an average of six months.
Pediatric Quality of Life Inventory 4.0 for children (PedsQL)
Time Frame: Trough study completion, an average of six months.
Pediatric Quality of Life Inventory 4.0 for children (PedsQL). PedsQL is a generic core scales instrument and contain 23-items in four scales, physical functioning, emotional functioning, social functioning, and school functioning. The higher scores indicate better health-related quality of life.
Trough study completion, an average of six months.
Participants', the children and parents psycho-social health during the family treatment
Time Frame: Trough study completion, an average of six months.
Questionnaires regarding negative side effects such as the occurrence of eating disorders, anxiety, or depression (Evira specific questionnaires).
Trough study completion, an average of six months.
Change in BMI
Time Frame: At three and six months follow-up.
Weight and height will be combined to report BMI in kg/m^2 for analyzing change in BMI Standard Deviation Score for the child and BMI for the parent.
At three and six months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Pernilla Danielsson, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FamEv2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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