Clinical trial NCT02342912: Social Media Obesity Treatment for College Students
Official title: Translation of Social Media Obesity Treatment Into Two College Campus Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
First posted: 2015-01-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight Loss
timeFrame: 18 months
measure: Weight Loss Difference
timeFrame: 18 months
Secondary outcomes:
measure: Metabolic Risk (Change in metabolic risk factors (including blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides)
timeFrame: 18 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
city: Boston
country: United States
facility: University of Massachusetts Boston
state: Massachusetts
Study officials:
affiliation: George Washington University
name: Melissa A Napolitano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Boston
name: Jessica A Whiteley, PhD
role: STUDY_DIRECTOR
References:
citation: Napolitano MA, Tjaden AH, Bailey CP, DiPietro L, Rimal R. What moves young people? Applying the risk perception attitude framework to physical activity behavior and cardiometabolic risk. Transl Behav Med. 2022 Jul 7;12(6):742-751. doi: 10.1093/tbm/ibac012.
citation: Napolitano MA, Whiteley JA, Mavredes MN, Faro J, DiPietro L, Hayman LL, Neighbors CJ, Simmens S. Using social media to deliver weight loss programming to young adults: Design and rationale for the Healthy Body Healthy U (HBHU) trial. Contemp Clin Trials. 2017 Sep;60:1-13. doi: 10.1016/j.cct.2017.06.007. Epub 2017 Jun 10.