Digital Wellness Nurse - FIT Families: Virtual Family Intervention for Adolescent Obesity
Recruiting · NCT07087808 · Interventional (participants receive a specific treatment) · Lead sponsor: Machine and Human Interaction
View the official record on ClinicalTrials.gov →Interventions studied
Digital Wellness Nurse - FIT Families
What this trial is about
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).
Who can take part
Age range
12 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- MUSC - Division of Global and Community Health - Charleston, South Carolina, United States