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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL145439-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Worcester Polytechnic Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Habit App | Experimental | Habit Mobile App |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Building Habits Together Online Weight Loss 6-Week Usability Trial | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 2 weeks |
| Mean Number of Exercise Problems Solved |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
We will adhere to the NIH Grant Policy on Sharing of Unique Research Resources. Any unique resources will be made available immediately after publication.
Procedures to protect the privacy of health data of individuals will be implemented to ensure NHLBI and HIPPA privacy standards are met. After the publication of outcome data, it will be made available to individuals who have IRB approval. The final dataset will be de-identified prior to sharing. Facebook participant engagement data is difficult to de-identify thus we do not intend to share it, unless we can be completely confident that participants cannot be identified.
We will insure that data and associated documentation is available to users only under a data sharing agreement that states a commitment to: 1) using the data only for research purposes, 2) securing the data using appropriate computer protection technology; and 3) destroying the data after analyses are completed. Datasets will be stored with encryption.
Immediately after publication
After the publication of outcome data, data will be made available to individuals who have IRB approval.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Posted | Mean | Standard Deviation | uses of this mobile app feature | 2 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherry Pagoto, PhD | University of Connecticut | 860-486-5917 | sherry.pagoto@uconn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2021 | Mar 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 7, 2022 | Mar 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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single-arm usability pilot
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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.
| 2 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| 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. | Posted | Mean | Standard Deviation | slips reported | 2 weeks |
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| 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. | Posted | Mean | Standard Deviation | temptations resisted | 2 weeks |
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| 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. | Posted | Mean | Standard Deviation | exercises planned | 2 weeks |
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| 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. | Posted | Mean | Standard Deviation | problems solved | 2 weeks |
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| 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. | Posted | Mean | Standard Deviation | diet problems solved | 2 weeks |
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| 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. | Posted | Mean | Standard Deviation | exercise problems solved | 2 weeks |
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| 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. | Posted | Count of Participants | Participants | 6 weeks |
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| 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. | Posted | Count of Participants | Participants | 6 weeks |
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| 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. | Posted | Count of Participants | Participants | 6 weeks |
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| 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. | Posted | Count of Participants | Participants | 6 weeks |
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| 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. | Posted | Count of Participants | Participants | 6 weeks |
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| 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. | Posted | Median | Inter-Quartile Range | total engagements | 6 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |