Obese Children and AdolescentsDWN-FITNCT07087808
Digital Wellness Nurse - FIT Families: Virtual Family Intervention for Adolescent Obesity
A study testing Digital Wellness Nurse - FIT Families in people with Obese Children and Adolescents, run by Machine and Human Interaction at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obese Children and Adolescents
- What is being tested?
- Digital Wellness Nurse - FIT Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
- Exclusion criteria that apply to both adolescents and caregivers:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MUSC - Division of Global and Community Health
Charleston, South Carolina, 29407
Jennifer Smith Powell, BA, 843-876-1840, smithjl@musc.edu
Phillippe Cunningham, PhD
About this study
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).
Read the 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
- Being tested
- Digital Wellness Nurse - FIT Families
- Keywords
- obesity, digital health, nutrition, Cognitive Behavioral Skills Testing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Wellness Nurse - FIT FamiliesBehavioural
Also called DWN-FIT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Digital Wellness Nurse - FIT Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The SUS will be delivered in week 6 of the intervention.
Secondary outcomes (5)
Body Fat Loss
We will ask participants to weigh themselves at least once each week using a provided smart scale (Etekcity) that records body fat percentage. This scale syncs with the DWN app automatically. The content, physical activity, and other program elements are designed to enhance behavior change toward body fat loss. This secondary outcome will determine the degree to which participants lose body fat over the 3-month treatment and will be measured in units of percent body fat.
Measured: 3 months
Body Weight Loss
We will ask participants to weigh themselves at least once each week using a provided smart scale (Etekcity) that records body weight. This scale syncs with the DWN app automatically. The content, physical activity, and other program elements are designed to enhance behavior change toward overall weight loss. This secondary outcome will determine the degree to which participants lose body weight over the 3-month treatment and will be measured in units of pounds.
Measured: 3 months
Engagement - Time on Task
We will determine the degree to which participants actively participate and engage in the digital wellness nurse activities, including video chats, reading content, completing assessments, and completing physical activity goals. This determination will be based on a daily activity report which will be generated from the application back-end. The first component of this report is participant engagement as measured by "time on task". Time on task will measure how much time, and in which parts of the app, the participants spent time. A weekly time on task cumulative measure will be calculated from adding the total time spent each day viewing learning content, answering assessment questions, and watching physical activity videos. The unit of measure for Time on Task is minutes.
Measured: 3 months
Engagement - Physical Activity
The second engagement measure will measure progress toward completion of physical activity goals. These goals include a weekly step count, exercise intensity, average daily heart rate, and exercise duration. Each of these goals comprises 25% of the physical activity engagement measure. The specific number of steps, exercise intensity, average daily heart rate, and exercise duration will be discussed and agreed upon by the participant and their provided health coach, therefore these specific goals will vary by participant. But physical activity engagement will be measured by percent completion of these goals. For example, in a given week, if a participant meets the step count and average daily heart rate goal, but misses the goals for exercise intensity and duration, the physical activity engagement measure would be 50%. Physical activity data is collected via Fitbit Charge 2 smart watch. The DWN app syncs physical activity data from the watch to the daily activity report.
Measured: 3 months
Adherence - Content Completion
The adherence measure will record progress toward completion of content goals. Each week the participant will be assigned a set of learning modules, each with an associated assessment. The percentage of the completed learning modules (denoted by completion of the associated assessment, at least 80% correct) will be used as a measure of content completion adherence. For example, if four learning modules are assigned for a given week, but only two are completed with assessment scores of at least 80%, then the content completion adherence measure would be 50%. Participants can retake assessments as many times as they desire, in order to reach the 80% benchmark.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start20 Jun 2025
- Primary completion14 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obese Children and AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Machine and Human Interaction
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Jerome McClendon, PhD, Principal investigator, Machine and Human Interaction LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087808
- Sponsor's protocol ID
- WCG#20251040
- Other IDs
- 1R41MD018558-01
- Acronym
- DWN-FIT
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Part of the study population are minors.
Publications
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.
PubMed 25870566Brooke, J. SUS-A quick and dirty usability scale. Usability Evaluation in Industry, 1996; 189(194), 4-7.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Wellness Nurse - FIT Families: Virtual Family Intervention for Adolescent Obesity
- ClinicalTrials.gov ID
- NCT07087808
- Acronym / sponsor ID
- DWN-FIT / WCG#20251040
- Conditions
- Obese Children and Adolescents
- Keywords
- obesity, digital health, nutrition, Cognitive Behavioral Skills Testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Machine and Human InteractionIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 14 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Support | Experimental | Behavioral: Digital Wellness Nurse - FIT FamiliesParticipants 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. |
| Control | Active comparator | Behavioral: Digital Wellness Nurse - FIT FamiliesThe 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 may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Wellness Nurse - FIT FamiliesAlso: DWN-FITParticipants 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. | Behavioural | Control, Social Support |
Primary outcome
Engagement
Time frame: The PHE survey will be taken via the DWN app at each time point, T0-T3 (wks 0,6, and 12)
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.
Usability
Time frame: The SUS will be delivered in week 6 of the intervention.
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.
5 secondary outcomes
Body Fat Loss
Time frame: 3 months
Body Weight Loss
Time frame: 3 months
Engagement - Time on Task
Time frame: 3 months
Engagement - Physical Activity
Time frame: 3 months
Adherence - Content Completion
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 25870566Graffigna 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.
- BackgroundBrooke, J. SUS-A quick and dirty usability scale. Usability Evaluation in Industry, 1996; 189(194), 4-7.
- Individual participant dataSharing planned: No. Part of the study population are minors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerome McClendon, PhD principal investigator
Machine and Human Interaction LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Wellness Nurse - FIT Families in people with Obese Children and Adolescents, run by Machine and Human Interaction at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Smith Powell, BA (843-876-1840, smithjl@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07087808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.