Digital Wellness Nurse - FIT Families: Virtual Family Intervention for Adolescent Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Engagement
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
结局指标
主要结局
Engagement
时间窗: 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
时间窗: 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.
Engagement
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)