Weight LossNCT02656680
Facebook and Friends: Developing an Effective Online Social Network for Weight Loss
A study testing Continuous Enrollment and Closed Enrollment in people with Weight Loss, run by University of Connecticut at 1 site in United States.
Trial summary
In a pilot randomized trial of 160 obese participants, investigators will test the feasibility of a behavioral weight loss program delivered entirely via Facebook. We will recruit in 2 separate waves of 80 participants each. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Continuous Enrollment and Closed Enrollment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be:
- 18-65 years of age;
- Have a BMI 27-45 kg/m²;
- Lives in the United States; and
- Have daily internet access;
Who cannot join
- Does not post on Facebook at least once per week
- Comments on someone else's post on Facebook less than once per week
- Does not currently use a smartphone;
- Is not familiar with using phone apps;
- Pregnant and/or lactating;
- Meets criteria for severe depression on the Patient Health Questionnaire (PHQ-9) (score of >20);
Show all 19Show fewer
- Had bariatric surgery, plans to during the study;
- Has had a weight loss of 5% or greater within previous 3 months;
- Meets criteria for Binge Eating Disorder;
- Condition that precludes lifestyle changes (i.e. a condition that prevents physical activity increase or dietary changes);
- Medications affecting weight;
- Incapable of walking ¼ mile without stopping;
- Type 1 or 2 diabetes;
- Participated in previous weight loss studies under the PI;
- Has concerns about being in a Facebook group with other faculty, staff, or students from the University of Connecticut;
- Has concerns about being audiotaped;
- Inability to provide consent;
- Prisoners; and
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Developing an Effective Online Social Network for Weight Loss
In a pilot randomized trial of 160 obese participants, investigators will test the feasibility of a behavioral weight loss program delivered entirely via Facebook. We will recruit in 2 separate waves of 80 participants each. Participants will be randomized to: 1) a condition with study participants only or 2) to a condition they will be able to invite their friends into (wave 1) or one in which the study team keeps recruitment open to allow enrollment through week 8 (wave 2). All participants will receive behavioral counseling via the private Facebook group from the coaches who are present on the network daily. Participants will track their diet and exercise via a free commercial mobile app.
Read the detailed description
The overarching goal of the research plan is to test ways to leverage mobile technologies and social media to increase the impact, scalability, cost-effectiveness, and dissemination potential of lifestyle interventions that reduce cardiovascular disease (CVD) risk. Mobile technology and social media have the potential to reduce the intensity of traditional prevention interventions and enhance outcome by delivering behavioral strategies in-the-moment and by connecting patients other patients to generate better communication and a social support system for lifestyle changes.
This study includes a behavioral weight loss program delivered entirely via on online social network. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will be connected to one another via Facebook and receive behavioral counseling via posts from coaches who are present on the network daily. Participants will track their diet and exercise via a free commercial mobile app. Participants will be assigned to either a Facebook group allowing the invite of friends (wave 1), a Facebook group with open enrollment through week 8 (wave 2) or a Facebook group including only study participants. If they are assigned to the group including their friends, they have the opportunity to invite their friends to participate in the weight loss group if they are interested in losing weight as well. They will not have a limit as to how many friends they can invite. The friends that are invited will not undergo the same procedures as the Facebook (FB)+friends study participants, but we will provide them with a factsheet and collect minimal information from them. If they are assigned to the group with open enrollment through week 8, additional people will be recruited into that group. Those participants being enrolled between week 1-8 will undergo the same procedures as others besides randomization. The goal of both of these studies is to explore how to build the size of online weight loss groups in such a way that increases participant engagement. Feasibility outcomes include engagement (frequency of posts, likes, and comments and number of completed days of tracking posted) retention, acceptability, and weight loss. Post intervention focus groups will gather feedback on the program.
- Conditions
- Weight Loss
- Being tested
- Continuous Enrollment, Closed Enrollment
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous EnrollmentBehavioural
Also called Open Group
Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8.
Closed EnrollmentBehavioural
Also called Closed Group
Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Enrollment (Randomized) | Experimental | The Continuous Enrollment is a Facebook-delivered weight loss intervention. Participants in this arm were randomized to this Facebook group and started the intervention together. For this group, the study team continued to enroll participants through week 8. Receives: Behavioral: Continuous Enrollment |
| Closed Enrollment (Randomized) | Active comparator | Closed Enrollment is a Facebook-delivered weight loss intervention. Participants in this arm were randomized to this Facebook group and started the intervention together. No additional participants were added to this group during the study. Receives: Behavioral: Closed Enrollment |
| Continuous Enrollment (Non-Randomized) | Other | The Continuous Enrollment is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8. This arm captures only those participants that were added to the group during these 8 weeks. They were enrolled in the study after the original 80 participants were randomized. Receives: Behavioral: Continuous Enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program.
Measured: 4 months
Retention
The number of participants who complete the follow-up assessment in each condition.
Measured: 4 months
Number of Participants Rating the Intervention 'Acceptable
Participants will rate acceptability of the online intervention. Acceptability was assessed with a single item during the follow-up survey: "How likely are you to recommend the program to a friend?" (responses on a 5-point Likert scale from not at all likely to very likely). Acceptability was categorized into acceptable, defined as responses of a little bit likely, somewhat likely, likely, and very likely, and unacceptable was defined as response of not at all likely.
Measured: 4 months
Secondary outcomes (2)
Percent Weight Loss
We calculated percent weight loss from baseline to 4 months.
Measured: Baseline to 4 months
Diet
The percentage of intervention days that a participant tracked diet and/or exercise in MyFitnessPal app. Any entry was counted as a day of tracking.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start1 Feb 2018
- Primary completion20 Feb 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sherry Pagoto, University of Connecticut
- Investigators
- Sherry Pagoto, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656680
- Sponsor's protocol ID
- H17-215
- Other IDs
- 1K24HL124366-01A1
- Status last verified
- Mar 2024
- First submitted
- 7 Jan 2016
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu R, Divito J, Bannor R, Schroeder M, Pagoto S. Predicting Participant Engagement in a Social Media-Delivered Lifestyle Intervention Using Microlevel Conversational Data: Secondary Analysis of Data From a Pilot Randomized Controlled Trial. JMIR Form Res. 2022 Jul 28;6(7):e38068. doi: 10.2196/38068.
PubMed 35900824Pagoto SL, Schroeder MW, Xu R, Waring ME, Groshon L, Goetz JM, Idiong C, Troy H, DiVito J, Bannor R. A Facebook-Delivered Weight Loss Intervention Using Open Enrollment: Randomized Pilot Feasibility Trial. JMIR Form Res. 2022 May 6;6(5):e33663. doi: 10.2196/33663.
PubMed 35522466
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Effective Online Social Network for Weight Loss
- ClinicalTrials.gov ID
- NCT02656680
- Acronym / sponsor ID
- H17-215
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a pilot randomized trial of 160 obese participants, investigators will test the feasibility of a behavioral weight loss program delivered entirely via Facebook. We will recruit in 2 separate waves of 80 participants each. Participants will be randomized to: 1) a condition with study participants only or 2) to a condition they will be able to invite their friends into (wave 1) or one in which the study team keeps recruitment open to allow enrollment through week 8 (wave 2). All participants will receive behavioral counseling via the private Facebook group from the coaches who are present on the network daily. Participants will track their diet and exercise via a free commercial mobile app.
Detailed description
The overarching goal of the research plan is to test ways to leverage mobile technologies and social media to increase the impact, scalability, cost-effectiveness, and dissemination potential of lifestyle interventions that reduce cardiovascular disease (CVD) risk. Mobile technology and social media have the potential to reduce the intensity of traditional prevention interventions and enhance outcome by delivering behavioral strategies in-the-moment and by connecting patients other patients to generate better communication and a social support system for lifestyle changes.
This study includes a behavioral weight loss program delivered entirely via on online social network. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will be connected to one another via Facebook and receive behavioral counseling via posts from coaches who are present on the network daily. Participants will track their diet and exercise via a free commercial mobile app. Participants will be assigned to either a Facebook group allowing the invite of friends (wave 1), a Facebook group with open enrollment through week 8 (wave 2) or a Facebook group including only study participants. If they are assigned to the group including their friends, they have the opportunity to invite their friends to participate in the weight loss group if they are interested in losing weight as well. They will not have a limit as to how many friends they can invite. The friends that are invited will not undergo the same procedures as the Facebook (FB)+friends study participants, but we will provide them with a factsheet and collect minimal information from them. If they are assigned to the group with open enrollment through week 8, additional people will be recruited into that group. Those participants being enrolled between week 1-8 will undergo the same procedures as others besides randomization. The goal of both of these studies is to explore how to build the size of online weight loss groups in such a way that increases participant engagement. Feasibility outcomes include engagement (frequency of posts, likes, and comments and number of completed days of tracking posted) retention, acceptability, and weight loss. Post intervention focus groups will gather feedback on the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Enrollment (Randomized) | Experimental | Behavioral: Continuous EnrollmentThe Continuous Enrollment is a Facebook-delivered weight loss intervention. Participants in this arm were randomized to this Facebook group and started the intervention together. For this group, the study team continued to enroll participants through week 8. |
| Closed Enrollment (Randomized) | Active comparator | Behavioral: Closed EnrollmentClosed Enrollment is a Facebook-delivered weight loss intervention. Participants in this arm were randomized to this Facebook group and started the intervention together. No additional participants were added to this group during the study. |
| Continuous Enrollment (Non-Randomized) | Other | Behavioral: Continuous EnrollmentThe Continuous Enrollment is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8. This arm captures only those participants that were added to the group during these 8 weeks. They were enrolled in the study after the original 80 participants were randomized. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years of age;
- Have a BMI 27-45 kg/m²;
- Lives in the United States; and
- Have daily internet access;
Key exclusion criteria (19 listed)
- Does not post on Facebook at least once per week
- Comments on someone else's post on Facebook less than once per week
- Does not currently use a smartphone;
- Is not familiar with using phone apps;
- Pregnant and/or lactating;
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 |
|---|---|---|
| Continuous EnrollmentAlso: Open GroupParticipants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8. | Behavioural | Continuous Enrollment (Non-Randomized), Continuous Enrollment (Randomized) |
| Closed EnrollmentAlso: Closed GroupParticipants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. | Behavioural | Closed Enrollment (Randomized) |
Primary outcome
Engagement
Time frame: 4 months
Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program.
Retention
Time frame: 4 months
The number of participants who complete the follow-up assessment in each condition.
Number of Participants Rating the Intervention 'Acceptable
Time frame: 4 months
Participants will rate acceptability of the online intervention. Acceptability was assessed with a single item during the follow-up survey: "How likely are you to recommend the program to a friend?" (responses on a 5-point Likert scale from not at all likely to very likely). Acceptability was categorized into acceptable, defined as responses of a little bit likely, somewhat likely, likely, and very likely, and unacceptable was defined as response of not at all likely.
2 secondary outcomes
Percent Weight Loss
Time frame: Baseline to 4 months
Diet
Time frame: 4 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35900824Xu R, Divito J, Bannor R, Schroeder M, Pagoto S. Predicting Participant Engagement in a Social Media-Delivered Lifestyle Intervention Using Microlevel Conversational Data: Secondary Analysis of Data From a Pilot Randomized Controlled Trial. JMIR Form Res. 2022 Jul 28;6(7):e38068. doi: 10.2196/38068.
- Derived from this study: PubMed 35522466Pagoto SL, Schroeder MW, Xu R, Waring ME, Groshon L, Goetz JM, Idiong C, Troy H, DiVito J, Bannor R. A Facebook-Delivered Weight Loss Intervention Using Open Enrollment: Randomized Pilot Feasibility Trial. JMIR Form Res. 2022 May 6;6(5):e33663. doi: 10.2196/33663.
- Individual participant dataSharing planned: No
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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.
Sherry Pagoto, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Enrollment and Closed Enrollment in people with Weight Loss, run by University of Connecticut at 1 site 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 5 inclusion and 19 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Engagement (time frame: 4 months). The study lists 3 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 NCT02656680, which also lists 2 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 21 Mar 2024.