A Remote Delivered Lifestyle Therapeutics Program: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
Heart disease is the leading cause of death in the United States. The overall risk for heart disease is a composite measure of various modifiable factors including blood pressure, cholesterol, and tobacco use; which are exacerbated by a sedentary lifestyle, unhealthy diet, and being overweight. Approximately 32% of the adult U.S. population has high blood pressure and 46% of them have uncontrolled hypertension. Successful management of high blood pressure and other cardiovascular risk is a complex process that requires significant lifestyle changes but adopting and adhering to these changes is challenging. A promise approach to overcoming these challenges is utilizing health coaching. The purpose of this research study is to compare at home devices for blood pressure and weight measurements (DEV) group compared to not using any at home devices Group (NODEV). Both groups will be supported throughout this study by meeting with obesity medicine doctor monthly in office and have a virtual health coaching visits throughout the study duration.
详细描述
Baseline Assessment Participants attend a baseline assessment with a study Health Coach that includes an overview and explanation of the study, the completion of several surveys that involve questions related to your overall health and demographics (age, race, etc). In addition, body weight using a scale and resting blood pressure using a blood pressure cuff. During participants will be asked to download the DiscoverHealth app which will be used to track daily nutritional information (food and drinks) and for health coaching sessions.
Groups Participants will then be randomly assigned to a device group (DEV) or a no device group (NODEV).
Control Group If randomly assigned to the NO DEV Group, participants will be asked to download the DiscoverHealth® app and daily input their nutritional information into the app. This will occur at the baseline assessment. Monthly participants will be asked to attend the Sleep Health Clinic to obtain body weight and blood pressure.
Intervention Group
Regardless of randomization (NODEV OR DEV) participants will be be asked to input their daily nutritional information (food) into the DiscoverHealth® app which will be used by the medical doctor and health coach.
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 (Care Provider)
盲法说明
Following baseline visits, participants were randomized to a no device (NODEV) or device (DEV) group via the website https://www.randomlists.com/team-generator.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English spoken and written at a high-school level, Obese according to body mass index (BMI) standards (> 30 kg/m2), Weigh less than 500 pounds, have access to an Apple® iPhone or Android® smart phone
排除标准
- •Participants were excluded if they have stated having an Immunodeficiency disorder Kidney disease; Type II diabetes; Asthma, COPD, Heart attack or stroke within the past 12 months; Presence of a partial or full artificial limb; Known dementia, brain cancer, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition; Medications, dietary supplements, or substances advertised to modify metabolism or body weight; Undergone major surgery less than 4 weeks prior to enrollment in the study; or were actively losing weight.
结局指标
主要结局
Weight loss
时间窗: Change in weight between baseline (week 0) and post intervention (week 26) ]
Investigators examined body weight changes between groups baseline (week 0) and post intervention (week 26).
Blood Pressure
时间窗: Change in blood pressure between baseline (week 0) and post intervention (week 26) ]
Investigators examined blood pressure changes between groups baseline (week 0) and post intervention (week 26).
次要结局
- HbA1c(Pre and Post (a 26 week study))
- Lipid Panel(Pre and Post (a 26 week study))
研究者
Kelly Johnson
Assistant Professor of Exercise and Sport Science
Coastal Carolina University