Recruiting

DWN App

Sponsor:

Machine and Human Interaction

Code:

NCT07087808

Conditions

Obese Children and Adolescents

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Digital Wellness Nurse - FIT Families

Study Details

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

Study ID

NCT07087808

Start date

Jun 20, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Nov 14, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

Primary outcome measure

  • Engagement [ Time Frame: The PHE survey will be taken via the DWN app at each time point, T0-T3 (wks 0,6, and 12) ]
  • Usability [ Time Frame: The SUS will be delivered in week 6 of the intervention. ]

Central Contacts and Locations

Central contacts

Jennifer Smith Powell, BA

843-876-1840smithjl@musc.edu

Locations

MUSC - Division of Global and Community Health

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Jennifer Smith Powell, BA

843-876-1840smithjl@musc.edu

Principal Investigator:

Phillippe Cunningham, PhD

More Information

Sponsor

Machine and Human Interaction

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Keywords

  • obesity
  • digital health
  • nutrition
  • Cognitive Behavioral Skills Testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Machine and Human Interaction on 2025-07-28.