DWN-FITDigital Wellness Nurse: Virtual Family Intervention for Adolescent Obesity Treatment
This study is a virtual family intervention for treating adolescent obesity, targeting engagement through the 9-item Patient Health Engagement survey and usability via the System Usability Scale assessment.
Digital Wellness Nurse - FIT Families
Body Weight+3
+ Nutrition Disorders
+ Obesity
Treatment Study
Summary
Study start date: June 20, 2025
Actual date on which the first participant was enrolled.This study focuses on a digital way to help African American teenagers aged 12 to 17 who are dealing with obesity. It uses a program called FIT Families, which is a special plan designed to support these teens and their families by changing behaviors that contribute to obesity. The study is important because it uses technology to make the program more accessible, helping families better engage with it. The aim is to see if using a digital tool can effectively support healthy lifestyle changes and encourage participation in activities like exercise and self-monitoring, which could improve the well-being of these teenagers. Participants in the study will use a mobile application that guides them through the FIT Families program. This app provides educational content, tracks progress, and collects data from devices like fitness trackers. The study also connects families with community health workers who offer support through weekly video meetings. Family members and friends can also send encouraging messages to participants through the platform. By monitoring how well the digital tool works, the study hopes to gather evidence to support the development of larger programs that could help even more families manage adolescent obesity effectively.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location