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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK098556-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Worcester Polytechnic Institute | OTHER |
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The purpose of this research was to develop and test the feasibility of Habit, a weight loss mobile application that was designed to coach patients through their weight loss challenges. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Smart Coach mobile application when paired with a shortened online-delivered (8-week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. Post-intervention focus groups discussed the feasibility and acceptability of the intervention. The investigators also performed exploratory analyses comparing conditions on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial.
The investigators developed and tested the feasibility of Habit, a weight loss mobile app that includes common features such as self-monitoring, goal setting, and a social network, but even more importantly, an avatar-facilitated, idiographic problem solving feature that processes information intelligently to help patients identify solutions to their weight loss problems. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Habit mobile application when paired with a shortened (8 week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. The investigators also performed analyses on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial. Data will support an efficacy trial of a Habit-assisted brief behavioral weight loss intervention relative to a brief behavioral weight loss intervention alone with 1 year follow-up. The investigators overarching goal is to develop mobile technology that reduces the intensity of lifestyle interventions as far as possible while preserving weight loss outcomes, to ultimately broaden reach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Weight Loss + Habit | Experimental | Participants will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Prevention Program Lifestyle Intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Total Uses) | Mean total uses of the problem solving function of the mobile application | 8-week follow-up |
| Feasibility (Total Habits Attempted) | Total amount of new habits attempted during the study | 8-week follow-up |
| Feasibility (Recruitment Rates) | Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43) | Baseline |
| Feasibility (Retention Rates) | Total attendance at groups and total withdrawn from the study | 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Problem Solving Inventory | The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0. |
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Inclusion: Participants must 1) have a BMI between 30 and 45, 2) currently uses a smartphone with Android software, 3) have connectivity to the internet at home and work, 4) have PCP written clearance, and 5) age 18 or older.
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry L 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 |
|---|---|---|---|
| 29925496 | Derived | Pagoto S, Tulu B, Agu E, Waring ME, Oleski JL, Jake-Schoffman DE. Using the Habit App for Weight Loss Problem Solving: Development and Feasibility Study. JMIR Mhealth Uhealth. 2018 Jun 20;6(6):e145. doi: 10.2196/mhealth.9801. |
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In order to begin the intervention, participants needed to complete: an online eligibility screener, a telephone screening, the consent process, a screening survey, medical clearance, and a webinar. Missing any of these components would be reason for exclusion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Weight Loss + Habit | Individuals randomized to this condition will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study. Diabetes Prevention Program Lifestyle Intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Weight Loss + Habit | Individuals randomized to this condition will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study. Diabetes Prevention Program Lifestyle Intervention |
| 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, 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 | Feasibility (Total Uses) | Mean total uses of the problem solving function of the mobile application | Posted | Mean | Standard Deviation | mean uses of the app | 8-week follow-up |
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Participants were in the study for 16 weeks and were monitored for the occurrence of adverse events throughout the study. Adverse events were documented during the interventions, at the 8-week assessment, and the 16-week assessment.
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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 | Behavioral Weight Loss + Habit | Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study. Diabetes Prevention Program Lifestyle Intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold, flu, or virus | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherry Pagoto, Professor | University of Massachusetts Medical School | 508-856-5159 | study@umassmed.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 8-week follow-up |
| % Weight Change | Measured in pounds with a digital scale | 8-week follow-up |
| % Weight Change | Measured in pounds with a digital scale | 16 week follow-up |
| Social Problem Solving Inventory | The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0. | 16-week follow-up |
| 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 | Number | participants |
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| Weight | Mean | Standard Deviation | pounds |
|
| Social-Problem Solving Inventory-Revised | The social problem solving inventory measures strengths and weaknesses in ability to solve problems. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The total score is being reported in these results. The scoring range includes 28 to 140. The higher the score the higher the problem solving ability. | Mean | Standard Deviation | Total score |
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| Facebook Use | Count of Participants | Participants |
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| Primary | Feasibility (Total Habits Attempted) | Total amount of new habits attempted during the study | Posted | Mean | Standard Deviation | mean habits attempted | 8-week follow-up |
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| Primary | Feasibility (Recruitment Rates) | Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43) | Of the total number of participants screened for this study (n=559), 7.69% (n=43) were enrolled into the intervention. | Posted | Count of Participants | Participants | Baseline |
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| Primary | Feasibility (Retention Rates) | Total attendance at groups and total withdrawn from the study | Posted | Count of Participants | Participants | 8-weeks |
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| Secondary | Problem Solving Inventory | The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0. | Posted | Mean | Standard Deviation | Total score | 8-week follow-up |
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| Secondary | % Weight Change | Measured in pounds with a digital scale | Posted | Mean | Standard Deviation | percentage of pounds | 8-week follow-up |
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| Secondary | % Weight Change | Measured in pounds with a digital scale | Posted | Mean | Standard Deviation | percentage of pounds | 16 week follow-up |
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| Secondary | Social Problem Solving Inventory | The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0. | Posted | Mean | Standard Deviation | Total score | 16-week follow-up |
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| 0 |
| 43 |
| 0 |
| 43 |
| 9 |
| 43 |
| Previous condition worsening | General disorders | Systematic Assessment |
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| Injury | General disorders | Systematic Assessment | Injured back while cleaning |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |