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DWN-FIT

Digital Wellness Nurse: Virtual Family Intervention for Adolescent Obesity Treatment

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Study AimThis study is a virtual family intervention for treating adolescent obesity, targeting engagement through the 9-item Patient Health Engagement survey and usability via the System Usability Scale assessment.
What is being tested

Digital Wellness Nurse - FIT Families

Behavioral
Who is being recruted

Obese Children and Adolescents

From 12 to 17 Years
+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: June 2025

See protocol details

Summary

Principal SponsorMachine and Human Interaction
Study ContactJennifer Smith Powell, BA
Last updated: July 28, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 20, 2025Actual date on which the first participant was enrolled.

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, which is a special plan designed to support these teens and their families by changing behaviors that contribute to obesity. The study is important because it uses technology to make the program more accessible, helping families better engage with it. The aim is to see if using a digital tool can effectively support healthy lifestyle changes and encourage participation in activities like exercise and self-monitoring, which could improve the well-being of these teenagers. Participants in the study will use a mobile application that guides them through the FIT Families program. This app provides educational content, tracks progress, and collects data from devices like fitness trackers. The study also connects families with community health workers who offer support through weekly video meetings. Family members and friends can also send encouraging messages to participants through the platform. By monitoring how well the digital tool works, the study hopes to gather evidence to support the development of larger programs that could help even more families manage adolescent obesity effectively.

Official TitleDigital Wellness Nurse - FIT Families: Virtual Family Intervention for Adolescent Obesity 
Principal SponsorMachine and Human Interaction
Study ContactJennifer Smith Powell, BA
Last updated: July 28, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
32 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 12 to 17 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Obese Children and Adolescents
Criteria
7 inclusion criteria required to participate
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)

Show More Criteria

9 exclusion criteria prevent from participating
Exclusion criteria for youth only
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)
xclusion criteria that apply to both adolescents and caregivers

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
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.
Study Objectives
Primary Objectives

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.

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.
Secondary Objectives

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.

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.

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.

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
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MUSC - Division of Global and Community HealthCharleston, United StatesSee the location
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One Study Center