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

NCT ID: NCT07087808

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2025-12-31

Brief Summary

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).

Conditions

Obese Children and Adolescents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Social Support

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 Type: EXPERIMENTAL

Digital Wellness Nurse - FIT Families

Intervention Type: BEHAVIORAL

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 not communicate with the CHW or participate in any treatment sessions. This person is selected by the family at the beginning of the study and provides reinforcement to the family through encouraging messages.

Control

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.

Group Type: ACTIVE_COMPARATOR

Digital Wellness Nurse - FIT Families

Intervention Type: BEHAVIORAL

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 not communicate with the CHW or participate in any treatment sessions. This person is selected by the family at the beginning of the study and provides reinforcement to the family through encouraging messages.

Interventions

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 not communicate with the CHW or participate in any treatment sessions. This person is selected by the family at the beginning of the study and provides reinforcement to the family through encouraging messages.

Intervention Type: BEHAVIORAL

Other Intervention Names

DWN-FIT

Eligibility 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

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)

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Machine and Human Interaction

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerome McClendon, PhD

Role: PRINCIPAL_INVESTIGATOR

Machine and Human Interaction LLC

Locations

MUSC - Division of Global and Community Health

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Smith Powell, BA

Role: CONTACT

smithjl@musc.edu

843-876-1840

Facility Contacts

Jennifer Smith Powell, BA

Role: primary

smithjl@musc.edu

843-876-1840

References

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.

Reference Type: BACKGROUND

PMID: 25870566 (View on PubMed)

Brooke, J. SUS-A quick and dirty usability scale. Usability Evaluation in Industry, 1996; 189(194), 4-7.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R41MD018558-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WCG#20251040

Identifier Type: -

Identifier Source: org_study_id