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Recruiting Not applicable

Digital Wellness Nurse - FIT Families: Virtual Family Intervention for Adolescent Obesity

NCT07087808 · tracked via the Priya Life Science USA tracker
Sponsor
Machine and Human Interaction
Phase
Not applicable
Started
2025-06-20
Last updated
2025-07-28

Condition(s) studied

Obese Children and Adolescents

Investigational drug(s) / intervention(s)

Digital Wellness Nurse - FIT Families

Digital Wellness Nurse - FIT Families: Participants in this arm will receive a digital adaptation of FIT families, an evidenced based treatment for adolescent obesity. The social support condition will add one additional participant to the treatment group (i.e., caregiver, youth, community health worker, and social support person). The social support person's role is to review the daily engagement reports and completion of weekly goals and provide encouragement via peer-to-peer messaging in the DWN app. The social support person does not communicate with the CHW or participate in any treatment sessions. This person is selected by the family at the beginning of the study and provides reinforcement to the family through encouraging messages.

Study summary

The purpose of the research is to evaluate the digital wellness nurse (DWN) app to find out if it is helpful in delivering the FIT Families intervention. The study is sponsored by the National Institutes of Health (NIH).

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: 1. Adolescents (ages 12-17) 2. Adolescent BMI ≥ 90th percentile for age and gender 3. Primary caregiver either overweight (BMI 25.0 to 29.9) or obese (BMI ≥ 30) and willing to participate in treatment 4. Adolescent residing primarily with the primary caregiver in a rural community (RUCA Codes 4-10) 5. Both caregiver and adolescent must have (separate) Android or Apple (iOS) smartphone with mobile internet connection 6. Adolescent and caregiver are English proficient 7. Supporters must be 18 years of age or older Exclusion Criteria: * Exclusion criteria for youth only: 1. Obesity secondary to medication use for another medical condition (e.g., steroids, antipsychotics) 2. Obesity secondary to a chronic condition (e.g., Down syndrome, Prader-Willi syndrome, Cushing's syndrome) Exclusion criteria that apply to both adolescents and caregivers: 1. Pregnancy (e.g., caregivers and youth will be asked each week if they expect if they are pregnant) 2. Mental/emotional disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal 3. Serious cognitive impairment (e.g., inability to complete questionnaires) 4. Medical condition where weight loss is contraindicated 5. Receiving or planned to receive other obesity treatments (e.g., pharmacologic treatment, bariatric surgery) within the next 6 months

Primary outcome measure(s)

  • Engagement — The PHE survey will be taken via the DWN app at each time point, T0-T3 (wks 0,6, and 12)
    We will measure engagement through the delivery of the 9-item Patient Health Engagement (PHE, Graffigna, et al., 2015) survey. The PHE is used to determine the degree to which patients are engaged in their own health and describes the patient's ability to manage their own health. PHE has been validated in other work, but a sample size large enough to meet this threshold is outside the scope of this study. The PHE outcomes gathered here will be used as preliminary data for future studies.
  • Usability — The SUS will be delivered in week 6 of the intervention.
    We will deliver a usability assessment via the System Usability Scale (SUS, Brooke, 1996) assessment focusing on the efficiency and effectiveness of accessing, delivering, and providing support during the intervention. The SUS includes topics such as readability, technology literacy, and interface design. These elements are combined into a semi-quantitative score for system usability.

Trial sites (1)

FacilityCityRegionStatus
MUSC - Division of Global and Community Health Charleston South Carolina Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07087808 on ClinicalTrials.gov ↗ ← All trials in the USA