Family Intervention for Treatment of Obesity With Digi-physical Support

• ClinicalTrials.gov Identifier: NCT06236906
• Recruitment Status: Not yet recruiting
• First Posted: February 1, 2024
• Last Update Posted: February 1, 2024
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Pernilla Danielsson, Karolinska Institutet

Tracking Information

• First Submitted Date: December 20, 2023
• First Posted Date: February 1, 2024
• Last Update Posted Date: February 1, 2024
• Estimated Study Start Date: February 1, 2024
• Estimated Primary Completion Date: December 20, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2024)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 31, 2024)

• Families adherence to treatment [ Time Frame: Trough study completion, an average of six months. ]
  Number of physical appointments, cancellations, and missed visits.
• 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
• 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.
• 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.
• 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).
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Family Intervention for Treatment of Obesity With Digi-physical Support
• Official Title: Digital-Physical Family Intervention in Primary Care for Families With Obesity in Both Children and Adults

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Childhood Obesity
• mHealth
• Personalized Medicine

Intervention

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 Name: Evira

Study Arms

Experimental: Intervention

Child and parent in digi-physical family treatment

Intervention: Device: Device supported behavioural treatment

Publications *

• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 31, 2024): 12
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 20, 2024
• Estimated Primary Completion Date: December 20, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pernilla Danielsson, PhD; +46 708377734; pernilla.danielsson-liljeqvist@regionstockholm.se

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06236906
• Other Study ID Numbers: FamEv2024
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• 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.

• Current Responsible Party: Pernilla Danielsson, Karolinska Institutet
• Original Responsible Party: Same as current
• Current Study Sponsor: Karolinska Institutet
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pernilla Danielsson, PhD; Karolinska Institutet

• PRS Account: Karolinska Institutet
• Verification Date: January 2024