A Pilot Randomized Controlled Trial of a Home Telenutrition Weight Loss Program in Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in Weight
研究概览
简要总结
This study is a 12-week pilot randomized controlled trial to test the feasibility and effectiveness of a home telenutrition weight loss program in men in West Virginia.
详细描述
This study is a 12-week pilot randomized controlled trial of a home telenutrition weight loss program for men with obesity and at least one additional risk factor for cardiovascular disease. The primary aims are to:
- To assess the feasibility and acceptability of the male-targeted telenutrition weight loss program in terms of recruitment, retention and satisfaction and
- To evaluate the effectiveness of the telenutrition program compared to usual care (informational only) with regard to primary and secondary outcome measures at 12 weeks. We hypothesized that men receiving virtual and telephonic support from a registered dietitian nutritionist would have greater weight loss and greater improvements in diet quality than men who were only provided educational materials.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •40-70 year old man
- •Body mass index ≥ 30
- •Living with spouse or companion
- •At least one of the following: hypertension, diabetes, pre-diabetes, hypercholesterolemia or hypertriglyceridemia
- •A home computer with high-speed internet access
- •A telephone for health coach phone calls
排除标准
- •Cancer (except skin or prostate), celiac disease, bacterial or viral infections, renal or liver disease (except non-alcoholic fatty liver disease), or condition that prevents fruits and vegetable consumption
- •Major surgery or health event (e.g., stroke, heart attack) in the past six months
- •Taking insulin, anti-obesity medications, steroids (e.g., Prednisone), or warfarin (Coumadin)
- •Pacemaker or defibrillator
- •Currently on a weight loss diet or lost > 10 pounds in past six months
- •Consume more than two alcoholic beverages daily
研究组 & 干预措施
Telenutrition Intervention
Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support.
干预措施: Registered Dietitian Nutritionist (RDN) Support (Behavioral)
Telenutrition Intervention
Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support.
干预措施: Diet-related educational materials (Behavioral)
Telenutrition Intervention
Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support.
干预措施: Self-monitoring tools (Behavioral)
Enhanced Usual Care Control
Participants receive diet-related educational materials and self-monitoring tools.
干预措施: Diet-related educational materials (Behavioral)
Enhanced Usual Care Control
Participants receive diet-related educational materials and self-monitoring tools.
干预措施: Self-monitoring tools (Behavioral)
结局指标
主要结局
Change in Weight
时间窗: Baseline to 12 weeks
次要结局
- Change in Body Composition(Baseline to 6 and 12 Weeks)
- Change in Caloric Intake(Baseline to 6 and 12 Weeks)
- Program Usefulness(6 and 12 Weeks)
- Change in Waist Circumference(Baseline to 6 and 12 weeks)
- Change in Diet and Diet Quality(Baseline to 6 and 12 Weeks)
- Health Related Quality of Life(Baseline and 12 Weeks)
- Program Satisfaction(6 and 12 Weeks)
研究者
Melissa Ventura-Marra
Assistant Professor
West Virginia University