Digital Wellness Nurse for Childhood Obesity

(DWN-FIT Trial)

Overseen By Jennifer Smith Powell, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Machine and Human Interaction

Must not be taking: Steroids, Antipsychotics

Disqualifiers: Pregnancy, Mental disorder, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app, the Digital Wellness Nurse, to determine its effectiveness in assisting families with the FIT Families program for managing childhood obesity. The study compares two groups: one using standard app features like video chats with a health coach, and another with added social support for encouragement. Families with adolescents aged 12-17 who are at or above the 90th percentile for BMI (a measure of body fat) and live in rural areas may be a good fit. Participants must have access to a smartphone with internet and be able to speak English.

As an unphased trial, this study offers families the chance to explore innovative digital health solutions for managing childhood obesity.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your obesity is due to medication use, you may not be eligible to participate.

What prior data suggests that the Digital Wellness Nurse app is safe for children?

Research shows that the Digital Wellness Nurse (DWN) app is designed to help families address childhood obesity. It offers tools such as video chats with health coaches and tracks physical activity and nutrition.

Previous studies have safely used similar digital tools. These studies aimed to encourage healthy habits and support weight management in children and teenagers, finding no serious safety issues. Most participants managed the digital tools well.

The trial is labeled as "Not Applicable" for phase, indicating limited safety data specific to this app. However, using digital platforms in healthcare is common and generally safe. Participants can expect a low risk of side effects since the app involves non-invasive digital communication and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Wellness Nurse for Childhood Obesity because it introduces a unique blend of digital health coaching and social support. Unlike standard treatments that typically involve basic lifestyle counseling and physical activity monitoring, this approach combines these elements with the assignment of a social support person. This added layer of encouragement and accountability aims to enhance motivation and adherence to healthy habits, which could be a game-changer in managing childhood obesity. By integrating technology with personal support, this treatment has the potential to create a more engaging and effective experience for young participants and their families.

What evidence suggests that the Digital Wellness Nurse app is effective for childhood obesity?

Research has shown that digital health tools like the Digital Wellness Nurse (DWN) app can help manage childhood obesity. In this trial, participants in the Social Support arm will use the DWN app and receive additional encouragement from a designated support person. A study on the DWN app found that children using it gained weight more slowly over 24 months compared to those who didn't use the app. Support from a family member or friend also increased the program's success. These digital tools can guide children and their families to make healthier lifestyle choices, leading to better weight management. ^{1 2 3 6 7}

Who Is on the Research Team?

Jerome McClendon, PhD

Principal Investigator

Machine and Human Interaction LLC

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 with obesity (BMI ≥ 90th percentile) and their primary caregivers who are also overweight or obese. Both must have a smartphone, speak English, and live in a rural area. Caregivers need to be willing to participate with the adolescent.

Inclusion Criteria

Adolescent residing primarily with the primary caregiver in a rural community (RUCA Codes 4-10)

I am between 12 and 17 years old.

Both caregiver and adolescent must have (separate) Android or Apple (iOS) smartphone with mobile internet connection

Exclusion Criteria

Mental/emotional disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal

Pregnancy

My obesity is due to medication I take for another health issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the FIT Families intervention using the DWN app, including video chats, physical activity monitoring, and educational content delivery

12 weeks

Weekly video conferences

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Wellness Nurse - FIT Families

Trial Overview The study tests a digital wellness nurse app called FIT Families, designed to help manage adolescent obesity. It's being evaluated for effectiveness in delivering health interventions virtually.

How Is the Trial Designed?

Group I: Social Support Experimental Treatment 1 Intervention

Participants in the social support arm will receive the same treatment as the control group, including video chatting with health coach, physical activity monitoring, and compensation via contingency management. In addition to these elements, these participants will also assign a social support person to provide them encouragement and accountability.

Group II: Control Active Control 1 Intervention

The Control arm features the standard digital FIT Families treatment, including video chat with health coach, physical activity, nutrition monitoring, and compensation through contigency management.

Who Is Running the Clinical Trial?

Machine and Human Interaction

Lead Sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. withpower.com withpower.com/trial/phase-obesity-5-2025-90461

Digital Wellness Nurse for Childhood Obesity (DWN-FIT Trial) 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11533126/

A Digital Health Behavior Intervention to Prevent ... The primary outcome was child weight-for-length trajectory over 24 months. Secondary outcomes included weight-for-length z score, body mass ...

3. patlynk.com patlynk.com/trial/NCT07087808

Virtual Family Intervention for Adolescent Obesity Treatment 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, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000336

Integrating digital health into pediatric obesity management In this narrative review, we focus on the main evidence regarding the effectiveness of DHIs for pediatric obesity treatment according to target (children vs.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-21120-5

The effectiveness of a 10-week family-focused e-Health ... This study evaluates the effectiveness of a 10-week e-Health (web-based) healthy lifestyle program for school-aged children with overweight/obesity.

6. medpagetoday.com medpagetoday.com/meetingcoverage/obesityweek/112730

Digital Intervention for Healthy Behaviors Helps Prevent ... Babies assigned to the digital intervention, which was started soon after birth, had a lower average weight-for-length trajectory at 24 months ...

7. pediatrics.jmir.org pediatrics.jmir.org/2021/1/e24714/

Digital Tools to Support Family-Based Weight Management for ... We developed a parent support focused program to treat childhood obesity that can be delivered in the home called DRIVE (Developing ...