Translation of Social Media Obesity Treatment Into Two College Campus Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Weight Loss Difference
研究概览
简要总结
This is a randomized trial designed to translate and deliver programs via social media for a healthy body weight to university students. Specifically, in this trial, we will randomly assign 450 overweight/obese (BMI between 25-45kg/m2) university students (ages 18-35) enrolled at two colleges (George Washington University and University of Massachusetts-Boston) to one of two social media weight loss treatments (personalized or generic) or a contact control. The social media treatments consist of Facebook groups to provide social support, connectedness and intervention content, as well as daily text messages. Assessments will be conducted at baseline, 6, 12, and 18 months post baseline, with the primary outcome being weight loss at 18 months. We hypothesize that: a) Tailored Social Media will lose significantly more weight at the above time points compared with Targeted Social Media. b) Both the Tailored Social Media and Targeted Social Media groups will have greater weight loss at the 6, 12, 18 month follow-ups than Contact Control. The secondary aim is to evaluate changes in metabolic risk factors among those participants who have maintained at least 5% weight loss at 18 months. We hypothesize that participants who achieve a 5% weight loss at 6 and 18 months will have significantly lower triglycerides, higher HDL cholesterol, and lower blood pressure than those who do not achieve and maintain that weight target. Finally, we will conduct additional formative work to evaluate the implementation feasibility of this intervention on college campuses, including an assessment of costs as well as the sustainability infrastructure using the PRISM (Practical, Robust Implementation and Sustainability Model) model as a guide. The results of this study have the potential to significantly impact the delivery of obesity treatment services on college campuses.
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
- 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 old
- •BMI between 25 and 45
- •Current student at GWU, UMB, or other approved college/university in the greater DC/Boston area available for assessments at months 6, 12 and 18
- •Fluent in English
- •Active Facebook user, as identified by current Facebook account, logged in at least one time in the past month
- •Regular text message access
排除标准
- •Untreated hypertension, hyperlipidemia, or type 2 diabetes, unless permission is provided by their health care provider. During screening visits, blood pressure will be assessed. Individuals with blood pressure levels >140/90 mmHg, will be informed of these levels and recommend that they contact their HCP. Study participation cannot commence or resume without HCP consent Note: Since weight control is an appropriate initial treatment for these medical issues, individuals can participate in the trial if they receive permission from their HCP, and the HCP indicates that he/she will be managing these risk factors. Participants who do not currently have a HCP will be connected with Student Health Services on each campus.
- •Heart disease, heart problems, or participants who report being prescribed drugs for blood pressure or a major heart condition, unless permission is received from their HCP. [PAR-Q]
- •Health problems which may influence the ability to walk for physical activity (e.g., chest pain during periods of activity, loss of consciousness or losing balance due to dizziness) or other reasons why a person should not do physical activity, unless permission is provided by their HCP. [PAR-Q]
- •Type 1 diabetes or treatment of type 2 diabetes with insulin or oral medications that may cause hypoglycemia (e.g. sulphonylureas). These individuals will be excluded to mitigate concerns about hypoglycemia in a weight loss program.
- •Health problems that may be associated with unintentional weight change or affect the safety of a weight loss program:
- •Report of a heart attack or stroke
- •Active tuberculosis
- •Chronic hepatitis B or C, or other chronic liver disease
- •Inflammatory bowel disease requiring treatment within the 12 months
- •Thyroid disease
- •Renal disease
- •Hospitalization for asthma or other lung disease in the past year
- •Chronic use of steroid medication.
- •Cancer within the past 5 years (except for non-melanoma skin cancers or early stage cervical cancer)
- •Report of a past diagnosis of or treatment for a DSM-V eating disorder (anorexia nervosa, bulimia nervosa, or binge eating disorder) or meet criteria as based on EDDS screening at start of trial
- •Report of a past diagnosis of or current symptoms of alcohol or substance dependence
- •Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months. These individuals may later be re-screened.
- •History of schizophrenia or bipolar disorder ("manic" depression)
- •Hospitalization for depression or other psychiatric disorder within the past 12 months
- •Currently trying to gain weight, or using steroids for muscle mass or weight gain
- •Bariatric (or weight loss) Surgery
- •Participation in another weight loss or physical activity study that would interfere with this study, or taking weight loss medication
- •A member of a participant's self-identified close social network is a participant
- •If graduate student, being in a support or evaluative role of undergraduate students on same campus (e.g., resident advisor/director, teaching assistant, coach). If so, this person may be excluded or asked to wait to join a cohort with students from other universities.
- •Reason to suspect that the participant would not adhere to the study intervention or assessment schedule
- •Medications - not stable on dosage for at least 3 months or HCP Clearance depending on medication type.
结局指标
主要结局
Weight Loss Difference
时间窗: 18 months
Mean differences in weight loss among intervention groups compared to control at 18-months post randomization
Weight Loss
时间窗: 18 months
Magnitude of weight loss among the three study groups
次要结局
- Metabolic Risk (Change in metabolic risk factors (including blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides)(18 months)
