Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34HL145439 | 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 |
|---|---|
| Worcester Polytechnic Institute | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this pilot trial is to evaluate the feasibility of a lifestyle intervention where participants will all receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app.
The purpose of this pilot trial is to evaluate the feasibility of a program where 70 adults with overweight or obesity will receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app. Participants randomized to the Habit app will be asked to record their weight daily, monitor their dietary temptations, plan their exercise, and solve diet and exercise related problems. The temptation tracker helps users identify triggers and track when and why those triggers lead to dietary lapses. The exercise planner allows users to plan their exercise for the week and track whether they completed or missed the exercise and why they missed it. The Habit app provides insights to users about the patterns of their dietary lapses and exercise habits. The problem solver feature helps users identify their biggest problem with diet/exercise and then asks a series of questions to help the app provide tailored solutions to the participant to work on. Participants randomized to MyFitnessPal will track their calorie intake and exercise daily during the intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Building Habits Together | Experimental | The Building Habits Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the Habit app (temptation tracking, exercise planning, and problem solving features). |
|
| Getting Healthy Together | Active Comparator | The Getting Healthy Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the MyFitnessPal app (daily calorie tracking, exercise tracking). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Building Habits Together | Behavioral | Private, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app. |
| Measure | Description | Time Frame |
|---|---|---|
| Mobile App Use | Investigators will calculate the number of days participants used their assigned app | 24 weeks |
| Retention | Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up | 24 weeks |
| Engagement Per Participant in the Facebook Group | For each participant, investigators will calculate total engagement in the Facebook group as defined as reactions (e.g., like, care, wow, etc.), replies, posts, and poll votes during the 24-week program. Then we will calculate mean or median engagement per participant over 24 weeks. | 24 weeks |
| Ease of Use (Acceptability) | Participants will rate how easy it was to use their assigned app (% who strongly agree/agree) | 24 weeks |
| Contamination | Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program. | 24 weeks |
| Time Consuming (Burden) | Participants will rate their assigned app in terms of whether they felt it took too much time out of their day (% who strongly agree/agree) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Baseline Weight Lost at 24 Weeks | Investigators will calculate percent weight change from baseline at 24 weeks | 24 weeks |
Not provided
Inclusion Criteria:
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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Building Habits Together | The Building Habits Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the Habit app (temptation tracking, exercise planning, and problem solving features). Building Habits Together: Private, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app. |
| FG001 | Getting Healthy Together | The Getting Healthy Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the MyFitnessPal app (daily calorie tracking, exercise tracking). Getting Healthy Together: Private, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Building Habits Together | The Building Habits Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the Habit app (temptation tracking, exercise planning, and problem solving features). Building Habits Together: Private, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app. |
| 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 | Mobile App Use | Investigators will calculate the number of days participants used their assigned app | Posted | Median | Inter-Quartile Range | days out of 168 total | 24 weeks |
|
6 months
Not provided
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 | Building Habits Together | The Building Habits Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the Habit app (temptation tracking, exercise planning, and problem solving features). Building Habits Together: Private, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| kidney failure | Renal and urinary disorders | Systematic Assessment | Participant was admitted to the hospital following blood work that revealed potential kidney failure stage 4/5. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherry Pagoto, PhD | University of Connecticut | (860) 486-5917 | sherry.pagoto@uconn.edu |
Not provided
| 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 | Oct 1, 2021 | Mar 18, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Getting Healthy Together | Behavioral | Private, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app. |
|
| BG001 | Getting Healthy Together | The Getting Healthy Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the MyFitnessPal app (daily calorie tracking, exercise tracking). Getting Healthy Together: Private, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | Retention | Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up | Posted | Number | participants | 24 weeks |
|
|
|
| Primary | Engagement Per Participant in the Facebook Group | For each participant, investigators will calculate total engagement in the Facebook group as defined as reactions (e.g., like, care, wow, etc.), replies, posts, and poll votes during the 24-week program. Then we will calculate mean or median engagement per participant over 24 weeks. | Posted | Median | Inter-Quartile Range | total reactions, replies, posts, votes | 24 weeks |
|
|
|
| Primary | Ease of Use (Acceptability) | Participants will rate how easy it was to use their assigned app (% who strongly agree/agree) | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Primary | Contamination | Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Primary | Time Consuming (Burden) | Participants will rate their assigned app in terms of whether they felt it took too much time out of their day (% who strongly agree/agree) | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Percentage of Baseline Weight Lost at 24 Weeks | Investigators will calculate percent weight change from baseline at 24 weeks | Posted | Mean | Standard Deviation | percent baseline weight lost | 24 weeks |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 0 |
| 35 |
| EG001 | Getting Healthy Together | The Getting Healthy Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the MyFitnessPal app (daily calorie tracking, exercise tracking). Getting Healthy Together: Private, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app. | 0 | 35 | 0 | 35 | 0 | 35 |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |