Obesity
Conditions
Brief summary
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.
Interventions
BEHAVIORALSocial Media Treatments
Each of the three intervention groups offers information that has been shown to be important for college students to have a healthy body weight. All three groups provide information on topics that we know are related to having a healthy body weight, like managing stress, keeping track of how you spend your time, and increasing self-awareness of certain health behaviors. Two of the three programs are focused on weight loss for a healthy body. The third group focuses on having a healthy mind, body and having energy during college.
Sponsors
University of Massachusetts, Boston
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 - 35 years old 2. BMI between 25 and 45 3. 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 4. Fluent in English 5. Active Facebook user, as identified by current Facebook account, logged in at least one time in the past month 6. Regular text message access
Exclusion criteria
1. 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. 2. 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. \[PAR-Q\] 3. 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. \[PAR-Q\] 4. 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. 5. 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 * HIV * 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) 6. 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 7. Report of a past diagnosis of or current symptoms of alcohol or substance dependence 8. 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. 9. History of schizophrenia or bipolar disorder (manic depression) 10. Hospitalization for depression or other psychiatric disorder within the past 12 months 11. Currently trying to gain weight, or using steroids for muscle mass or weight gain 12. Bariatric (or weight loss) Surgery 13. Participation in another weight loss or physical activity study that would interfere with this study, or taking weight loss medication 14. A member of a participant's self-identified close social network is a participant 15. 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. 16. Reason to suspect that the participant would not adhere to the study intervention or assessment schedule 17. Medications - not stable on dosage for at least 3 months or HCP Clearance depending on medication type.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 18 months | Magnitude of weight loss among the three study groups |
| Weight Loss Difference | 18 months | Mean differences in weight loss among intervention groups compared to control at 18-months post randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Risk (Change in metabolic risk factors (including blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides) | 18 months | Change in metabolic risk factors (including blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides) across the three groups and the associated thresholds of weight loss and corresponding metabolic risk. |
Countries
United States
Outcome results
None listed