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OpenTrials
Completed

NCT Number: NCT02342912

Social Media Obesity Treatment for College Students

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The George Washington University, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)
  • 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.

Treatment and study plan

Social Media Treatments

Behavioral

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.

Primary outcomes

  1. Weight Loss

    Time frame: 18 months

    Magnitude of weight loss among the three study groups

  2. Weight Loss Difference

    Time frame: 18 months

    Mean differences in weight loss among intervention groups compared to control at 18-months post randomization

Secondary outcomes

  1. Metabolic Risk (Change in metabolic risk factors (including blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • University of Massachusetts, Boston

Registry information

Official study title

Translation of Social Media Obesity Treatment Into Two College Campus Communities

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 21, 2015
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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