Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
Although weight loss programs are effective in the short-term, maintaining weight loss is more challenging. Regularly tracking and logging physical activity (PA) and diet is related to greater improvements in PA and diet and to greater weight loss over time. Receiving continuous real-time feedback regarding calories burned and calories consumed could enhance weight loss maintenance. This study will examine whether a device that provides such feedback, called the SenseWear armband, enhances weight maintenance.
200 overweight adults aged 18 to 65 years will be randomly assigned to one of four groups: (1) a standard behavior change weight loss group-based program (14 group sessions over a 4 month period followed by 6 phone calls over a 5 month period), (2) a standard behavior change weight loss group-based program (15 group session over a 4 month period followed by 6 phone calls over a 5 month period) combined with the armband, (3) the armband alone (training in the use of the armband and a follow up telephone call), or (4) a self-directed weight loss control group.
Participants will be recruited through USC through listserv emails, flyers, and worksite advertisements. Interested individuals will take part in a telephone screen, an orientation, a run-in visit (which includes 2 weeks of PA and dietary logging), a baseline assessment, and a randomization visit. The intervention will then take place over a 9-month period with eligible participants. Participants will take part in follow-up assessments at month 4 and 9. Assessments at all three times will include questionnaires assessing diet, PA, psychosocial factors related to diet and PA, and quality of life related measures. They will also have their fasting blood drawn to assess lipids, glucose, and insulin, and staff will measure their blood pressure, waist circumference (size), skinfold, height, and weight.
详细描述
Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management Research Summary Steven N. Blair, PED, Principal Investigator
Primary Aim
Dr. Blair and the investigative team will evaluate the contribution of the BodyMedia metabolic monitoring system to weight loss within the context of a standard behavioral weight loss program, and also as a stand alone system. The BodyMedia system consists of a metabolic monitor (armband) and computer software that analyzes energy expenditure, duration and level of physical activity, and other metabolic processes in free-living conditions. The proposed study will test the following hypotheses:
- The standard behavioral weight loss program (Standard), BodyMedia augmented program (Armband), and the Armband Alone will produce more weight loss and reduction in waist circumference over 4 months and maintain greater weight loss and reduction in waist circumference than does a usual care self-help program (Usual Care).
- The Armband program will produce weight loss and reduction in waist circumference comparable to the Standard program over 4 months.
- The Armband Alone program will produce weight loss and reduction in waist circumference comparable to the Standard program after 9 months.
- The Armband program will produce weight loss and reduction in waist circumference greater than the Standard program after 9 months.
Primary Outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years older men & women
- •Body mass index 25.0-39.9
- •Ability to provide informed consent
排除标准
- •Type I Diabetes
- •Type II diabetes taking insulin
- •Surgery or Hospitalization in last year (unless minor outpatient surgery)
- •Blood pressure >159/94
- •Cancer (other than non-melanoma skin cancer) in last 5 years
- •History of bariatric surgery
- •Current treatment with herbal, over-the-counter, or prescription weight loss drugs
- •Current treatment with ant-metabolite medications or other medications that affect weight
- •Current pregnancy or breastfeeding, or plans pregnancy in next 18 months gastrointestinal disorders including ulcerative colitis, Crohn's disease, malabsorption syndromes)
- •Chronic renal insufficiency
- •Chronic liver disease
- •History of anorexia nervosa, bulimia, laxative abuse
- •Current alcohol or substance abuse
- •Chronic heart failure, New York Heart Association Class III or IV
- •Uncontrolled arrythmia
- •Uncontrolled hyper- or hypothyroidism
- •Large weight loss of 20 or more kilograms in the past year
- •Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness
- •Center for Epidemiologic Studies Depression Scale Score ≥ 16
- •Musculoskeletal problems interfering with exercise.
- •Autoimmune or collagen vascular diseases.
- •Immunodeficiency diseases or a positive Human immunodeficiency virus test
- •Unable to give informed consent
研究组 & 干预措施
A - GWL
Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.
干预措施: Group weight loss program (Behavioral)
B - GWL+SWA
Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
干预措施: Group weight loss program plus use of the Senseware Armband (Other)
C - SWA Alone
Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
干预措施: Use of the senseware armband alone program (Device)
D - Standard Care
Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
结局指标
主要结局
Body Weight
时间窗: 4 month
Waist Circumference
时间窗: 4 month
次要结局
- Blood Fasting Glucose(Month 9)
研究者
Steven N. Blair
Distinguished Professor Emeritus
University of South Carolina