Weight Loss
Conditions
Brief 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. 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.
Interventions
BEHAVIORALContinuous Enrollment
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.
BEHAVIORALClosed Enrollment
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must be: 1. 18-65 years of age; 2. Have a BMI 27-45 kg/m²; 3. Lives in the United States; and 4. Have daily internet access;
Exclusion criteria
1. Does not post on Facebook at least once per week 2. Comments on someone else's post on Facebook less than once per week 3. Does not currently use a smartphone; 4. Is not familiar with using phone apps; 5. Pregnant and/or lactating; 6. Meets criteria for severe depression on the Patient Health Questionnaire (PHQ-9) (score of \>20); 7. Had bariatric surgery, plans to during the study; 8. Has had a weight loss of 5% or greater within previous 3 months; 9. Meets criteria for Binge Eating Disorder; 10. Condition that precludes lifestyle changes (i.e. a condition that prevents physical activity increase or dietary changes); 11. Medications affecting weight; 12. Incapable of walking ¼ mile without stopping; 13. Type 1 or 2 diabetes; 14. Participated in previous weight loss studies under the PI; 15. Has concerns about being in a Facebook group with other faculty, staff, or students from the University of Connecticut; 16. Has concerns about being audiotaped; 17. Inability to provide consent; 18. Prisoners; and 19. Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement | 4 months | Number of Facebook likes and other reactions, replies, posts, and polls per participant during the 16 week program. |
| Retention | 4 months | The number of participants who complete the follow-up assessment in each condition. |
| Number of Participants Rating the Intervention 'Acceptable | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Loss | Baseline to 4 months | We calculated percent weight loss from baseline to 4 months. |
| Diet | 4 Months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| 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. | 54 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 7 |
Baseline characteristics
| Characteristic | FB+Friends | FB Only | Non-Randomized Participants in FB+Friends Group | Total |
|---|---|---|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 10.6 | 40.4 years STANDARD_DEVIATION 11.8 | 40.3 years STANDARD_DEVIATION 10.6 | 40.2 years STANDARD_DEVIATION 11.2 |
| Body Mass Index | 34.0 kg/m^2 STANDARD_DEVIATION 4.6 | 34.8 kg/m^2 STANDARD_DEVIATION 5.4 | 34.5 kg/m^2 STANDARD_DEVIATION 4.3 | 34.4 kg/m^2 STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 36 Participants | 50 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 36 Participants | 36 Participants | 44 Participants | 116 Participants |
| Region of Enrollment United States | 40 participants | 40 participants | 54 participants | 134 participants |
| Sex: Female, Male Female | 34 Participants | 34 Participants | 50 Participants | 118 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 4 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 54 |
| other Total, other adverse events | 13 / 40 | 6 / 40 | 0 / 54 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 54 |
Outcome results
Primary
Engagement
Number of Facebook likes and other reactions, replies, posts, and polls per participant during the 16 week program.
Time frame: 4 months
Population: Wave 2 All Randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FB+Friends | Engagement | 77.00 Total Engagements |
| FB Only | Engagement | 116.50 Total Engagements |
| Non-Randomized Participants in FB+Friends Group | Engagement | 46.0 Total Engagements |
Comparison: Mann-Whitney U Testp-value: 0.72Wilcoxon (Mann-Whitney)
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.
Time frame: 4 months
Population: Wave 2 Participants Who Completed Acceptability Survey Question
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FB+Friends | Number of Participants Rating the Intervention 'Acceptable | 31 Participants |
| FB Only | Number of Participants Rating the Intervention 'Acceptable | 36 Participants |
| Non-Randomized Participants in FB+Friends Group | Number of Participants Rating the Intervention 'Acceptable | 44 Participants |
p-value: 0.69Chi-squared
Primary
Retention
The number of participants who complete the follow-up assessment in each condition.
Time frame: 4 months
Population: Wave 2 Only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FB+Friends | Retention | 40 Participants |
| FB Only | Retention | 39 Participants |
| Non-Randomized Participants in FB+Friends Group | Retention | 47 Participants |
Comparison: Chi square test comparing proportion retained in each condition.p-value: 0.31Chi-squared
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.
Time frame: 4 Months
Population: randomized wave 2 sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB+Friends | Diet | 37.87 percentage of days of diet tracking | Standard Deviation 29.49 |
| FB Only | Diet | 32.41 percentage of days of diet tracking | Standard Deviation 31 |
| Non-Randomized Participants in FB+Friends Group | Diet | 30.12 percentage of days of diet tracking | Standard Deviation 28.97 |
p-value: 0.421ANOVA
Secondary
Percent Weight Loss
We calculated percent weight loss from baseline to 4 months.
Time frame: Baseline to 4 months
Population: Randomized Sample; FB Only condition excludes 1 participant for pregnancy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB+Friends | Percent Weight Loss | -3.0844 percent change | Standard Deviation 4.28 |
| FB Only | Percent Weight Loss | -1.8713 percent change | Standard Deviation 4.41 |
| Non-Randomized Participants in FB+Friends Group | Percent Weight Loss | -2.8 percent change | Standard Deviation 4.5 |
Comparison: We compared mean percent weight loss from baseline across groups with a one-way ANOVA. One participant became pregnant and thus removed from the analysis. This analysis is exploratory given that this pilot study was not powered to detect weight loss differences between groups.p-value: 0.218ANOVA