Obesity
Conditions
Keywords
obesity, lifestyle intervention, mobile app
Brief summary
The purpose of this 6 week single-arm pilot is to evaluate the feasibility of the Habit app plus Facebook group intervention in 20 adults with obesity. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app.
Detailed description
The purpose of this single-arm pilot is to evaluate the feasibility of the intervention in 20 adults with obesity. We define feasibility as use of the mobile app features (dietary self-monitoring, slip tracker, and problem sharing/solving), retention, engagement (overall, problem solving), acceptability, and burden. This study will give us information that we can use to modify the intervention and our procedures before the larger pilot study. We will enroll 20 adults with obesity to participate in the 6-week pilot. Eligible participants will receive a link to complete surveys, mailed a wifi scale, and asked to provide staff with login information for the scale so weight can be recorded during assessments. They will then have a 60-minute call with a counselor to 1) download and receive training on program technology (MyFitnessPal, Habit app, and Fitbit scale) and 2) be entered into the Facebook group. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app. Every Monday in the group, participants will be given one diet and one exercise goal for the week and every Sunday they will be asked to share their progress on those goals. Every Friday they will participate in a weigh in thread in the group. In addition to the group, for the first two weeks, participants will be asked to use MyFitnessPal; for the second two weeks, they will be asked to use the Temptation/Slip Tracker and Exercise Planner; and for the final two weeks they will be asked to use the Problem Solver. We will ask each participant to share at least one diet or exercise problem with the group over the 6 weeks and to participate in each other's problem solving posts. Participants may attend optional weekly breakout sessions where weight loss related problems will be discussed. On the final day of the intervention, a post will go up in the group asking for a volunteer who used the app enough to brainstorm how to improve it to participate in a team meeting to discuss how to improve the program. If more than one participant volunteers, one will be randomly selected to participate. After the 6-week intervention, participants will complete the weight loss problem solving skills survey, provide a final weight, and complete individual phone interviews to discuss their experience. We will convene a team meeting with the investigators, interventionists, and a participant to discuss the results and any modifications that should be made to the program before progressing to the pilot study.
Interventions
BEHAVIORALBuilding Habits Together Online Weight Loss 6-Week Usability Trial
The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Worcester Polytechnic Institute
University of Connecticut
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
single-arm usability pilot
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years old 2. BMI 30-45 kg/m2 3. has wifi connectivity at home (for wifi scale) 4. logs into Facebook at least 5 days per week over the past 2 weeks, and has posted/replied at least once a week in the past 2 weeks 5. able to participate in the study in English.
Exclusion criteria
1. Pregnant/lactating or plans to become pregnant during study period 2. bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression 3. had bariatric surgery or plans to have surgery during the study 4. currently taking medication affecting weight 5. has lost ≥10% of weight in past year 6. is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving 7. chronic pain that interferes with the ability to exercise 8. Type 1 or 2 Diabetes 9. unable to make dietary changes or increase physical activity 10. unable to walk ¼ mile unaided without stopping 11. currently smokes or vapes nicotine 12. does not live in the United States 13. had major surgery in past 6 months 14. hospitalized for psychiatric reasons in past 12 months 15. has concerns about being audiotaped during the focus groups 16. does not have or not willing to create Fitbit account for study 17. unable to access smartphone at home and at work 18. does not have FB 19. has done a study with this PI before 20. has concerns about being in FB group with faculty/students of same university in which they work/attend 21. does not have smartphone 22. smartphone type/version not meeting app requirements 23. prisoner 24. unable to provide consent 25. does not complete onboarding steps for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Uses of the Temptation Tracker | 2 weeks | Participants were asked to use the temptation tracker on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server. |
| Mean Number of Slips Reported | 2 weeks | Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server. |
| Mean Number of Temptations Resisted | 2 weeks | Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server. |
| Mean Number of Exercises Planned | 2 weeks | Participants were asked to plan their exercise in advance on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server. |
| Mean Number of Total Problems Solved | 2 weeks | Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server. |
| Mean Number of Diet Problems Solved | 2 weeks | Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server. |
| Mean Number of Exercise Problems Solved | 2 weeks | Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server. |
| Number of Participants Saying They Agree or Strongly Agree They Would Continue to Use the Habit App if Given the Chance | 6 weeks | Participants will rate how much they agree with the statement I would continue to use the Habit app after the study if given the chance on 5-point Likert scales. |
| Number of Participants Saying They Agree or Strongly Agree That They Would Recommend the Habit App to a Friend | 6 weeks | Participants will rate how much they agree with the following statement I would recommend the Habit app to a friend who is trying to lose weight on a 5-point Likert scale. |
| Number of Participants Rating the Temptation and Slip Tracker as Time-consuming | 6 weeks | Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (temptation/slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree. |
| Number of Participants Rating the Problem Solver as Time-consuming | 6 weeks | Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree. |
| Number of Participants Rating the Exercise Planner as Time-consuming | 6 weeks | Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree. |
| Median Total Engagements in the Facebook Group | 6 weeks | Using Grytics, we will retrieve objective engagement data from the Facebook group, including the date and content of all posts, replies, reactions, and poll votes. We will calculate the total number of posts, replies, reactions, and poll votes per participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Habit App Habit Mobile App
Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Habit App |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 41.8 years STANDARD_DEVIATION 9.1 |
| Body Mass Index | 32.8 kg/m^2 STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Mean Number of Diet Problems Solved
Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habit App | Mean Number of Diet Problems Solved | 1.9 diet problems solved | Standard Deviation 1.5 |
Primary
Mean Number of Exercise Problems Solved
Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habit App | Mean Number of Exercise Problems Solved | 1.0 exercise problems solved | Standard Deviation 0.5 |
Primary
Mean Number of Exercises Planned
Participants were asked to plan their exercise in advance on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habit App | Mean Number of Exercises Planned | 14.0 exercises planned | Standard Deviation 10.5 |
Primary
Mean Number of Slips Reported
Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habit App | Mean Number of Slips Reported | 4.8 slips reported | Standard Deviation 3.5 |
Primary
Mean Number of Temptations Resisted
Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habit App | Mean Number of Temptations Resisted | 4.7 temptations resisted | Standard Deviation 6.1 |
Primary
Mean Number of Total Problems Solved
Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habit App | Mean Number of Total Problems Solved | 2.9 problems solved | Standard Deviation 2 |
Primary
Mean Number of Uses of the Temptation Tracker
Participants were asked to use the temptation tracker on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habit App | Mean Number of Uses of the Temptation Tracker | 9.5 uses of this mobile app feature | Standard Deviation 6.3 |
Primary
Median Total Engagements in the Facebook Group
Using Grytics, we will retrieve objective engagement data from the Facebook group, including the date and content of all posts, replies, reactions, and poll votes. We will calculate the total number of posts, replies, reactions, and poll votes per participant.
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Habit App | Median Total Engagements in the Facebook Group | 62 total engagements |
Primary
Number of Participants Rating the Exercise Planner as Time-consuming
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Habit App | Number of Participants Rating the Exercise Planner as Time-consuming | 11 Participants |
Primary
Number of Participants Rating the Problem Solver as Time-consuming
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Habit App | Number of Participants Rating the Problem Solver as Time-consuming | 11 Participants |
Primary
Number of Participants Rating the Temptation and Slip Tracker as Time-consuming
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (temptation/slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Habit App | Number of Participants Rating the Temptation and Slip Tracker as Time-consuming | 14 Participants |
Primary
Number of Participants Saying They Agree or Strongly Agree That They Would Recommend the Habit App to a Friend
Participants will rate how much they agree with the following statement I would recommend the Habit app to a friend who is trying to lose weight on a 5-point Likert scale.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Habit App | Number of Participants Saying They Agree or Strongly Agree That They Would Recommend the Habit App to a Friend | 10 Participants |
Primary
Number of Participants Saying They Agree or Strongly Agree They Would Continue to Use the Habit App if Given the Chance
Participants will rate how much they agree with the statement I would continue to use the Habit app after the study if given the chance on 5-point Likert scales.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Habit App | Number of Participants Saying They Agree or Strongly Agree They Would Continue to Use the Habit App if Given the Chance | 11 Participants |