Social Media Obesity Treatment for College Students

NCT02342912 | Completed DMC

• 1 other identifier: R01DK100916
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Weight Loss

  Magnitude of weight loss among the three study groups

  18 months

• Weight Loss Difference

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

  18 months

Secondary Outcomes (1)

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

  18 months

Study Arms (3)

Social Media Targeted Treatment

EXPERIMENTAL

Participants randomly assigned to this treatment arm will receive weight loss materials via text messages, Facebook postings, on-line videos, and weekly reports. The topics relate to relate to behavioral and lifestyle changes associated with weight-loss (e.g., nutrition, exercise, social support, and self-monitoring). Calorie and physical activity targets also are set. Participants will receive a suggestion to track diet, physical activity, and weight.

Behavioral: Social Media Treatments

Social Media Tailored Treatment

EXPERIMENTAL

Participants randomly assigned to this treatment arm receive all of the same weight loss materials (as well as weight, calorie, and physical activity targets) as the Targeted group above. Weekly reports will be more personalized to help participants track diet, physical activity, and weight. Additionally, participants will be asked to report on their weight, exercise and calorie goals, and receive feedback.

Behavioral: Social Media Treatments

Social Media Contact Control

ACTIVE COMPARATOR

Participants randomly assigned to this treatment arm receive health information via text messages, Facebook postings, on-line videos, and weekly reports. Topics relate to having a healthy body weight through a healthy mind, body, and energy. Some topics include stress management, importance of sleep, and importance of accepting one's body. Participants will receive a suggestion to track stress, body image, and energy levels.

Behavioral: Social Media Treatments

Interventions

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.

Social Media Contact Control; Social Media Tailored Treatment; Social Media Targeted Treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• George Washington University: lead
• University of Massachusetts, Boston: collaborator

Study Sites (2)

The George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

Related Publications (3)

• Whiteley JA, Tjaden AH, Bailey CP, Faro J, DiPietro L, Hayman LL, Napolitano MA. Engagement with Digital Weight Loss Intervention Components and Weight Outcomes. J Technol Behav Sci. 2024 Dec;9(4):714-723. doi: 10.1007/s41347-024-00388-9. Epub 2024 Feb 3.

  PMID: 41122737 DERIVED

• 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.

  PMID: 35429404 DERIVED

• 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.

  PMID: 28611007 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Melissa A Napolitano, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Jessica A Whiteley, PhD

  University of Massachusetts, Boston

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 21, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 10, 2020

Record last verified: 2019-07

Locations

US (2)