Digital Wellness Nurse FIT Families program for teen obesity
Digital Wellness Nurse - FIT Families: Virtual Family Intervention for Adolescent Obesity
This project tests whether a smartphone-based Digital Wellness Nurse can help 12–17-year-old African American teens with obesity and their caregivers follow a family-based weight-management program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Machine and Human Interaction Industry-sponsored |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07087808 on ClinicalTrials.gov |
What this trial studies
The trial tests a digital adaptation of the FIT Families family-based behavioral program delivered through a smartphone app called the Digital Wellness Nurse (DWN). Adolescents (12–17) with obesity and their primary caregivers use the app for education, self-monitoring, wearable data collection, and social support while community health workers monitor progress and meet weekly by video. The platform automates reminders and incentive prompts tied to adherence and allows additional family members to send encouragement. The primary focus is feasibility in rural African American families, measuring uptake, adherence, and acceptability of the digital delivery.
Who should consider this trial
Good fit: Ideal participants are English‑proficient African American adolescents aged 12–17 with BMI at or above the 90th percentile who live primarily with an overweight or obese caregiver in a rural community and both have smartphones with internet.
Not a fit: Those whose obesity is secondary to medications or chronic/genetic conditions, pregnant individuals, people with serious mental or emotional conditions, non‑English speakers, or families without individual smartphones or mobile internet are unlikely to qualify or to benefit.
Why it matters
Potential benefit: If successful, the DWN could expand access to evidence-based family obesity treatment in rural communities and improve teens’ self-monitoring, physical activity, and weight outcomes.
How similar studies have performed: Behavioral family programs like FIT Families have shown benefit in prior trials, but fully automated mobile nurse platforms are newer and have limited direct evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, South Carolina
- MUSC - Division of Global and Community Health — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jerome McClendon, PhD — Machine and Human Interaction LLC
- Study coordinator: Jennifer Smith Powell, BA
- Email: smithjl@musc.edu
- Phone: 843-876-1840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.