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

Overview

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).

Detailed description

The focus of the DWN for this study, in collaboration with the Medical University of South Carolina (MUSC), is to evaluate its feasibility in delivering key components of FIT Families (HL155793), a multicomponent behavioral intervention designed to treat 12-to-17-year-old African American (AA) adolescents with obesity (AAAO).

The study aims to expand the FIT Families intervention through a digital adaptation that utilizes mobile technology and automation to increase access and adherence. Specifically, the DWN platform will assist AAAOs and their primary caregivers (participants) in understanding, tracking, and completing intervention components; delivering educational content when needed; and collecting information from external sources such as wearables. An analysis of their progression will provide the participants' incentives for adhering to intervention components, for example increasing their participation in self-monitoring (SM) and physical activity (PA). The DWN enables social support (SS) by allowing additional family members or friends to offer messages of encouragement to the participants throughout the treatment. Using our web-based dashboard, community health workers (CHWs) will monitor the progress of their families, meeting with them weekly via video conference within the DWN mobile application.

DWN-FIT will evaluate the feasibility of a digital intervention to expand access and facilitate adherence to family-oriented, evidence-based treatment for AAAOs and their caregivers. Additionally, the realization of DWN-FIT will enable future research and development of evidence-based digital interventions targeting AAAOs. Successful outcomes of the proposed work will provide the evidence needed to support a larger, more comprehensive randomized clinical trial and commercialization of DWN (Phase II).

Interventions

• Behavioral 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

Primary outcome measures

• Engagement [Time frame: The PHE survey will be taken via the DWN app at each time point, T0-T3 (wks 0,6, and 12)]
• Usability [Time frame: The SUS will be delivered in week 6 of the intervention.]

Secondary outcome measures (5)

• Body Fat Loss [Time frame: 3 months]
• Body Weight Loss [Time frame: 3 months]
• Engagement - Time on Task [Time frame: 3 months]
• Engagement - Physical Activity [Time frame: 3 months]
• Adherence - Content Completion [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• Adolescents (ages 12-17)
• Adolescent BMI ≥ 90th percentile for age and gender
• Primary caregiver either overweight (BMI 25.0 to 29.9) or obese (BMI ≥ 30) and willing to participate in treatment
• Adolescent residing primarily with the primary caregiver in a rural community (RUCA Codes 4-10)
• Both caregiver and adolescent must have (separate) Android or Apple (iOS) smartphone with mobile internet connection
• Adolescent and caregiver are English proficient
• Supporters must be 18 years of age or older

Exclusion criteria

• Exclusion criteria for youth only:

• Obesity secondary to medication use for another medical condition (e.g., steroids, antipsychotics)
• 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:

• Pregnancy (e.g., caregivers and youth will be asked each week if they expect if they are pregnant)
• Mental/emotional disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal
• Serious cognitive impairment (e.g., inability to complete questionnaires)
• Medical condition where weight loss is contraindicated
• Receiving or planned to receive other obesity treatments (e.g., pharmacologic treatment, bariatric surgery) within the next 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• MUSC - Division of Global and Community Health — Charleston

Publications

• Graffigna G, Barello S, Bonanomi A, Lozza E. Measuring patient engagement: development and psychometric properties of the Patient Health Engagement (PHE) Scale. Front Psychol. 2015 Mar 27;6:274. doi: 10.3389/fpsyg.2015.00274. eCollection 2015. PMID 25870566
• Brooke, J. SUS-A quick and dirty usability scale. Usability Evaluation in Industry, 1996; 189(194), 4-7.

Identifiers

NCT: NCT07087808 · WCG#20251040 · 1R41MD018558-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗