Evaluating Innovative Weight Reduction Strategies for College Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 441
- 试验地点
- 3
- 主要终点
- Change in Body Mass Index (BMI)
研究概览
简要总结
Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students
详细描述
The goal of this research is to develop and test innovative strategies to help prevent unhealthy weight gain in college students attending 2-year community or technical colleges. The intervention we propose for Phase 2, and will refine through our formative experiences in Phase 1, will be based on social ecological and social networks models with students randomized to conditions. Students (n=440) with BMIs between 20.0 and 34.9 will be recruited to participate in an intervention trial that lasts 24 months. After the initial screening and consent procedures, students will complete baseline measures that include: assessment of body composition; blood pressure and a blood draw; a behavioral and psychosocial survey; medical and weight history and two 24-hour online dietary recalls. After the completion of baseline assessments, students will be randomized into treatment or control conditions. Students randomized into the intervention condition will participate in a 1-credit course offered through their 2-year college that focuses on eating, activity, sleep and stress management as ways to help maintain or achieve a healthy weight; three course sections will be offered to accommodate students' scheduling needs and learning preferences. A web-based social network and support component will be introduced as part of this course and will continue as the intervention channel for 20 months following the 1-credit course. This supported intervention phase will use a study-designed website to reinforce, inform and encourage exchange and support between all intervention participants. Students will be asked to track their weight and weight-control behaviors on the website and intervention staff will interact with participants electronically or through phone calls offering encouragement and helping with problem solving. Control students will receive their health assessments and usual care including existing public health information on maintaining a healthy weight and information regarding health services offered on their school's campus. The effectiveness and sustainability of the intervention approaches will be evaluated.
The primary aim is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect BMI in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment, as compared to students randomized to the control condition.
The secondary aims of this study are to: 1) Examine the effectiveness of a weight gain prevention intervention to positively affect weight in 2-year college students' and 2) compare the effects of the intervention and control groups with regard to change in BMI and weight from baseline to four months and from baseline to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-35 years
- •Intending to be available for a 24 month intervention
排除标准
- •Unable to provide informed consent
- •BMI < 18.5 kg/m2, >/=35 kg/m2
- •Household member on study staff
- •Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/physical activity/weight loss intervention study
- •Regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected). "Regular use" is defined as "taking this medication most days of the week for the previous month"
- •Current treatment for an eating disorder
- •Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
- •Current treatment for malignancy (other than non-melanoma skin cancer)
- •Investigator discretion
- •Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months.
- •Systolic BP at screening >/= 160 mmHg or diastolic BP >/= 100 mmHg. If BP exceeds this level, participants can return for re-screening after being evaluated and treated for hypertension.
- •Weight loss of more than 15 lbs over the past three months
- •Trying to gain weight.
研究组 & 干预措施
Intervention Group
The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website
干预措施: CHOICES Intervention (Behavioral)
Control Group
Control group (serving as a comparison group)
结局指标
主要结局
Change in Body Mass Index (BMI)
时间窗: Baseline to 24 Months
The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.
次要结局
- Prevalence of Overweight/Obese(Baseline to 24 Months)
- Change in BMI From Baseline to 4 Months(Baseline to 4 Months)
- Change in Weight From Baseline to 12 Months(Baseline to 12 Months)
- Change in Weight From Baseline to 4 Months(Baseline to 4 Months)
- Change in BMI From Baseline to 12 Months(Baseline to 12 Months)