EMPOWER Weight Loss Program for Obesity in Rural and Underserved Areas Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Completion of study measures
研究概览
简要总结
This research is to expand a virtual weight loss and weight maintenance program to rural counties of Illinois. The program uses dietary and lifestyle modifications for adults with obesity. The EMPOWER weight loss program has proven to be effective in 3 previous trials. In this research, we target a rural participant population. Individuals in rural locations are more likely to be affected by obesity and have unique barriers to weight loss related to geographic isolation including access to health care, preventative care, grocery stores, social networks, internet, and cell service.
详细描述
EMPOWER is a remote weight management program that uses an online textbook platform, E-Text, and mobile web application, MealPlot. This pilot study will test for feasibility of the EMPOWER program in a rural population prior to launching a full-scale study. Acceptability measurements will be collected at 3 months to evaluate for needed changes; Participants of the pilot study will be permitted to continue on with the full program.
EMPOWER is a 1-year intervention. Data is collected via 24-hour record and daily weighing using a Wi-Fi-enabled scale. 24-hour records and daily weights are collected within the program's proprietary MealPlot website. EMPOWER consists of 17 online sessions (45 minutes/each) and 12 individual advising sessions with a nutrition coach.
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
- •age 18-75 years;
- •BMI in overweight to above range;
- •not currently pregnant or lactating;
- •willing to access Wi-Fi via home or free public Wi-Fi location at least once a week for 45 minutes
- •access to a working email
- •willing to weigh daily and provide data either via Bluetooth, Wi-Fi, or manual input
- •willing to lose 20 lb. or more and maintain a healthy weight for one year thereafter;
- •Continue daily-weighing for 12-months after the year-long intervention (Daily weigh for a total of 2 years);
- •fluent in reading and writing English.
- •live within one of the counties of the covered Extension Education offices: Eastern (Clark, Crawford, Edgar), Northern (Jo Daviess, Stephenson, Winnebago), Western (Macoupin, Christian, Jersey, Montgomery)
排除标准
- •age <18 or >75 years;
- •severe chronic diseases;
- •underweight to normal BMI;
- •currently pregnant;
- •currently lactating;
- •failed to commit to daily weighing;
- •failed to submit 3, 24 hour records;
- •underwent bariatric surgery or planning on having bariatric surgery within the next year including: Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Duodenal Jejunal Bypass with Sleeve Gastrectomy, Duodenal Switch, Laparoscopic Adjustable Gastric Banding.
研究组 & 干预措施
Weight Management Intervention
During a 12-month period, participants will attend a total of 17 diet improvement sessions, each of which will last approximately 45-minutes. 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. Flexibility in session completion will be allowed to accommodate busy schedules, vacation, and potential internet access challenges.
干预措施: Weight Management Intervention (Behavioral)
结局指标
主要结局
Completion of study measures
时间窗: 12 Months
Completion of 80% of study measures (24-hour records, in-person anthropometric testing)
Enrollment
时间窗: 3 Months
Achieving target enrollment 16
Retention
时间窗: 3 Months
Successful retention dropout \<20% (13/16)
Completion of eText
时间窗: 12 Months
Completion of eText (75% completion)
Acceptability
时间窗: 3 Months
4/5 on average for all program components and overall program using Likert scales (ranging 1-5) of acceptability (comprehensive program, MealPlot, eText, nutrition coaching) collected via survey.
次要结局
- Dietary Habits - fiber density(1 Year)
- Weight loss(1 Year)
- Dietary habits - protein density(1 Year)