Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K24HL124366-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Enrollment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement | Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program. | 4 months |
| Retention | The number of participants who complete the follow-up assessment in each condition. | 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. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Loss | We calculated percent weight loss from baseline to 4 months. | 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. |
Not provided
Inclusion Criteria:
Participants must be:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sherry Pagoto, PhD | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35900824 | Derived | 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. | |
| 35522466 | Derived | Pagoto 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
At the start of the 16-week trial, we randomized participants (n=80) to two groups: 'Facebook (FB)+Friends' (n=40) or 'FB Only' (n=40). For the first 8 weeks of the trial, we continued to add new participants (n=54) into the 'FB+Friends' group. Our total enrollment (n=134) includes these 54 post-randomized participants. We did not include the post-randomized sample in the analysis for this record.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FB+Friends | FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8. 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. |
| FG001 | FB Only | FB Only Facebook-delivered weight loss intervention including only study participants. FB Only: 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. |
| FG002 | Non-Randomized Participants in FB+Friends Group | These participants were recruited into the FB+Friends group through week 8 of the intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Wave 2 Randomized Sample
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FB+Friends | FB+Friends is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8. FB + Friends: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Engagement | Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program. | Wave 2 All Randomized | Posted | Median | Inter-Quartile Range | Total Engagements | 4 months |
|
Adverse events were collected over the period of 16 weeks.
Adverse events were assessed during follow-up as well as documented when participants reported them during the intervention. Pregnancy was only assessed with female participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FB+Friends | FB+Friends is a Facebook-delivered weight loss intervention. The study team will keep recruitment open for this condition to allow enrollment through week 8. 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherry Pagoto | University of Connecticut | 8604868979 | sherry.pagoto@uconn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2021 | Feb 18, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2021 | Feb 22, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2019 | Feb 18, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Closed Enrollment | Behavioral | 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. |
|
|
| 4 Months |
| BG001 | FB Only | FB Only Facebook-delivered weight loss intervention including only study participants. FB Only: 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. |
| BG002 | Non-Randomized Participants in FB+Friends Group | This group of participants were enrolled into the FB+Friends group during weeks 1-8 of the intervention, thereby receiving the same intervention as that group. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Non-Randomized Participants in FB+Friends Group |
These participants were recruited into the FB+Friends group during weeks 1-8. |
|
|
|
| Primary | Retention | The number of participants who complete the follow-up assessment in each condition. | Wave 2 Only | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Primary | 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. | Wave 2 Participants Who Completed Acceptability Survey Question | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Secondary | Percent Weight Loss | We calculated percent weight loss from baseline to 4 months. | Randomized Sample; FB Only condition excludes 1 participant for pregnancy | Posted | Mean | Standard Deviation | percent change | Baseline to 4 months |
|
|
|
|
| Secondary | 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. | randomized wave 2 sample | Posted | Mean | Standard Deviation | percentage of days of diet tracking | 4 Months |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 13 |
| 40 |
| EG001 | FB Only | FB Only Facebook-delivered weight loss intervention including only study participants. FB Only: 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. | 0 | 40 | 0 | 40 | 6 | 40 |
| EG002 | Non-Randomized Participants in FB+Friends Group | Non-Randomized Participants in the FB+Friends Group includes the participants in this condition who enrolled between week 1 and week 8. 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. | 0 | 54 | 0 | 54 | 0 | 54 |
| Weight Gain | General disorders | Systematic Assessment | Pts gained 5% or more of baseline weight during intervention |
|
| Had Surgery or Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Began Taking Medication Affecting Weight | General disorders | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Only Assessed in Females |
|
| Respiratory Illness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastrointestinal Illness | Gastrointestinal disorders | Non-systematic Assessment |
|
| Losing Vision Due to Genetic Disorder | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Binge Eating Disorder | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided