EMPOWER: Individualized Dietary Improvement Program
试验速览
- 阶段
- 不适用
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This research is to develop a virtual weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.
详细描述
EMPOWER is a remote weight management program utilizing an online textbook platform, E-Text, and mobile web application. EMPOWER is a two-year program: 1-year intervention, 1-year follow up. Data is collected via FFQ (NIH DHQIII), daily weighing using a wifi-enabled scale, and 24-hour dietary records via the web application. EMPOWER consists of 19 online sessions (45 minutes/each) and 3 individual advising sessions with an RD.
EMPOWER aims to improve health parameters related to obesity, such as hyperlipidemia and hypertension. Health parameters will be monitored primarily by the subject's personal physician. Any test results will be sent to the EMPOWER research team for analysis via REDCap.
EMPOWER team consists of social workers in addition to nutrition experts. The social work team aims to monitor and improve lifestyle, stress management, and behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index in the overweight or obese range (BMI) >28 kg/m2 (if Asian, BMI >25kg/m2);
- •not currently pregnant or lactating;
- •have Wi-Fi at home, a working email, and an iPhone or Android smartphone;
- •self-reported obesity co-morbidities (such as diabetes type 2 or hyperlipidemia);
- •be a Carle Foundation Hospital patient and have regular contact with a primary care physician;
- •not using insulin injection;
- •able to attend the 22 (1 hour) diet improvement sessions;
- •willing and safe to lose 20 lb. or more for 6 months and maintain a healthy weight for one year;
- •keep weighing their weight for two years;
- •fluent in reading and writing English.
排除标准
- •age <18 or >75 years;
- •body mass index of <28 kg/m2 (if Asian, BMI <25kg/m2);
- •currently pregnant;
- •currently lactating;
- •use insulin injection;
- •not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
- •failed to set up a Wi-Fi scale;
- •failed to submit a FFQ.
研究组 & 干预措施
Weight Management Intervention
During a 12-month period, participants will attend a total of 22 diet improvement sessions, each of which will last approximately 1 hour. Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss. The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference. The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating. The participants will build skills to select foods and create meals that prevent them from overeating. Participants will be followed by daily self-weighing for 1 year after intervention.
干预措施: Weight Management Intervention (Behavioral)
结局指标
主要结局
Body weight
时间窗: Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month
Body weight in kilograms measured on a standard scale (Withings, US)
次要结局
- Body composition(Change from baseline (0 month) to 6 month, 12 month, 24 month)
- Fiber Intake(Periodically from baseline (0 month) to 12 month)
- Waist circumference(Change from baseline (0 month) to 6 month,12 month, 24 month)
- Hip circumference(Change from baseline (0 month) to 6 month, 12 month, 24 month)
- Protein Intake(Periodically from baseline (0 month) to 12 month)
- Health parameters as identified by subject's personal physician(As ordered by personal physician from baseline (0 month) to 24 months)
- Blood pressure(Change from baseline (0 month) to 6 month, 12 month, 24 month)
- Protein Intake(Change from baseline (0 month) to 12 month)
- Fiber Intake(Change from baseline (0 month) to 12 month)
研究者
Mindy Lee
Graduate Research Assistant
University of Illinois at Urbana-Champaign