ObesityNCT02342912
Social Media Obesity Treatment for College Students
A study testing Social Media Treatments in people with Obesity, run by George Washington University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Social Media Treatments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Massachusetts Boston
Boston, Massachusetts, 02125
The George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: Translation of Social Media Obesity Treatment Into Two College Campus Communities
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
- Being tested
- Social Media Treatments
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Media TreatmentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Social Media Treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Magnitude of weight loss among the three study groups
Measured: 18 months
Weight Loss Difference
Mean differences in weight loss among intervention groups compared to control at 18-months post randomization
Measured: 18 months
Secondary outcomes (1)
Metabolic Risk (Change in metabolic risk factors (including blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Responsible party
- Sponsor
- Investigators
- Melissa A Napolitano, PhD, Principal investigator, George Washington UniversityJessica A Whiteley, PhD, Study director, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342912
- Sponsor's protocol ID
- R01DK100916
- Status last verified
- Jul 2019
- First submitted
- 16 Dec 2014
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41122737Napolitano 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.
PubMed 35429404Napolitano 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.
PubMed 28611007
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of Social Media Obesity Treatment Into Two College Campus Communities
- ClinicalTrials.gov ID
- NCT02342912
- Acronym / sponsor ID
- R01DK100916
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Study start
- Feb 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Media Targeted Treatment | Experimental | Behavioral: Social Media TreatmentsParticipants 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. |
| Social Media Tailored Treatment | Experimental | Behavioral: Social Media TreatmentsParticipants 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. |
| Social Media Contact Control | Active comparator | Behavioral: Social Media TreatmentsParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (27 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Media TreatmentsEach 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. | Behavioural | Social Media Contact Control, Social Media Tailored Treatment, Social Media Targeted Treatment |
Primary outcome
Weight Loss
Time frame: 18 months
Magnitude of weight loss among the three study groups
Weight Loss Difference
Time frame: 18 months
Mean differences in weight loss among intervention groups compared to control at 18-months post randomization
1 secondary outcome
Metabolic Risk (Change in metabolic risk factors (including blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Derived from this study: PubMed 41122737Whiteley 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.
- Derived from this study: PubMed 35429404Napolitano 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.
- Derived from this study: PubMed 28611007Napolitano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa A Napolitano, PhD principal investigator
George Washington University
Jessica A Whiteley, PhD study director
University of Massachusetts, Boston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Media Treatments in people with Obesity, run by George Washington University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342912, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.