NCT06569121招募中不适用
Efficacy of an Evidence-based Telehealth-delivered Weight-loss Intervention to Enhance Access and Reach Underserved Groups After Stroke
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
Investigators will conduct a randomized controlled trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-CVA (tGLB-CVA) compared to a 6-month wait-list control (WLC) in partnership with a diverse group of patient partners and peer mentors.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index ≥25
- •All types of stroke
- •Able to Participate in Physical Activity
- •≥12 months post first stroke
- •Have internet, phone, or computer access, or be willing to use one provided by the study team
排除标准
- •Contraindications for physical activity
- •Low Cognitive Function
- •Residing in hospital, acute rehab, skilled nursing facility
- •Not fluent in the English language
- •Pre-existing eating disorder
- •Pregnancy
结局指标
主要结局
Body Weight
时间窗: Baseline, 3, 6, 9, 12, 18 month
Body weight (lbs) will be captured via self-weighing using provided BodyTrace Smart Scale, which includes cellular connectivity so weight will be sent directly to the research team. The scales have demonstrated good concordance rates with self-weighing in previous research. Scales will be setup by the research team before being mailed to participants with instructions.
次要结局
- Blood Glucose(Baseline, 3, 6, 9, 12, 18 month)
- Circumference(Baseline, 3, 6, 9, 12, 18 month)
- Height(Baseline, 3, 6, 9, 12, 18 month)
- Body Mass Index (BMI)(Baseline, 3, 6, 9, 12, 18 month)
- Blood pressure(Baseline, 3, 6, 9, 12, 18 month)
- Blood Sugar, Hemoglobin A1c (HbA1c)(Baseline, 3, 6, 9, 12, 18 month)
- High Density Lipoprotein (HDL) cholesterol(Baseline, 3, 6, 9, 12, 18 month)
- Low Density Lipoprotein (LDL) cholesterol(Baseline, 3, 6, 9, 12, 18 month)
- Fasting venous sample(Baseline, 3, 6, 9, 12, 18 month)
- 8-year Diabetes Risk(Baseline, 3, 6, 9, 12, 18 month)
- Metabolic Syndrome Severity Score(Baseline, 3, 6, 9, 12, 18 month)
- Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, 3, 6, 9, 12, 18 month)
- Substance Use(Baseline, 12, 18 month)
- Neighborhood Environment Walkability Scale (NEWS)(Baseline, 3, 6, 9, 12, 18 month)
- Social Support for Healthy Eating (SSEH)(Baseline, 3, 6, 9, 12, 18 month)
- Quality of Life(Baseline, 3, 6, 9, 12, 18 month)
- Self-Rated Abilities for Health Practice(Baseline, 3, 6, 9, 12, 18 month)
- Social Support for Physical Activity (SSPA)(Baseline, 3, 6, 9, 12, 18 month)
- Care Partner Healthy Lifestyle Support Tool(Baseline, 3, 6, 9, 12, 18 month)
- Telehealth Usability and Satisfaction(6, 12, 18 month)
- Exit Survey & Interview(12 or 18 month)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Leveraging Telehealth to Improve Oral Health Among Cancer SurvivorsOral MucositisPeriodontal DiseasesCancerNCT06315855Georgetown University100
已完成
不适用
Expanding Rural Access to Breastfeeding Support Via Telehealth: The Tele-MILC TrialBreastfeedingNCT02870413RAND203
进行中（未招募）
不适用
Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise ToleranceChildhood CancerMobility LimitationNCT04714840St. Jude Children's Research Hospital181
已完成
不适用
DIgital Assisted MONitoring for DiabeteS - IDiabetes MellitusNCT01804803University of Bari123
已完成
不适用
Telehealth Group Intervention for Perinatal Depressive SymptomsPerinatal DepressionNCT03932760University of Utah99