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

NCT07087808 | Recruiting

• 2 other identifiers: WCG#202510401R41MD018558-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Obese Children and Adolescents

Keywords

obesity; digital health; nutrition; Cognitive Behavioral Skills Testing

Outcome Measures

Primary Outcomes (2)

• Engagement

  We will measure engagement through the delivery of the 9-item Patient Health Engagement (PHE, Graffigna, et al., 2015) survey. The PHE is used to determine the degree to which patients are engaged in their own health and describes the patient's ability to manage their own health. PHE has been validated in other work, but a sample size large enough to meet this threshold is outside the scope of this study. The PHE outcomes gathered here will be used as preliminary data for future studies.

  The PHE survey will be taken via the DWN app at each time point, T0-T3 (wks 0,6, and 12)

• Usability

  We will deliver a usability assessment via the System Usability Scale (SUS, Brooke, 1996) assessment focusing on the efficiency and effectiveness of accessing, delivering, and providing support during the intervention. The SUS includes topics such as readability, technology literacy, and interface design. These elements are combined into a semi-quantitative score for system usability.

  The SUS will be delivered in week 6 of the intervention.

Secondary Outcomes (5)

• Body Fat Loss

  3 months

• Body Weight Loss

  3 months

• Engagement - Time on Task

  3 months

• Engagement - Physical Activity

  3 months

• Adherence - Content Completion

  3 months

Study Arms (2)

Social Support

EXPERIMENTAL

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.

Behavioral: Digital Wellness Nurse - FIT Families

Control

ACTIVE COMPARATOR

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.

Behavioral: Digital Wellness Nurse - FIT Families

Interventions

Digital Wellness Nurse - FIT Families 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.

Also known as: DWN-FIT

Control; Social Support

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Machine and Human Interaction: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

MUSC - Division of Global and Community Health

Charleston, South Carolina, 29407, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 25870566 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jerome McClendon, PhD

  Machine and Human Interaction LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Smith Powell, BA

CONTACT

843-876-1840; smithjl@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 28, 2025
• Study Start: June 20, 2025
• Primary Completion: November 14, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)