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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL122302-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Worcester Polytechnic Institute | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This research is being done is to evaluate the feasibility and acceptability of a novel weight loss mobile app that was designed to be less burdensome than traditional weight loss apps.
Obesity and stress are highly comorbid and both increase risk for cardiovascular disease (CVD). Stress is associated with disinhibited eating, junk food consumption and low consumption of produce and whole grains. Both stress and stress-induced eating are not only associated with obesity but also predict worst outcomes in lifestyle interventions. Stress and stress-induced eating should be targeted in interventions to maximize weight loss; however, this makes for a very intensive intervention. Technology could be leveraged to reduce intervention burden.
In this trial investigators propose to compare the feasibility, usability, acceptability, and burden of an traditional weight loss app that includes diet and physical activity self-monitoring features to an app (Slip Buddy) we developed that focuses on self-monitoring of stress eating. With Slip Buddy, the user is just asked to track overeating episodes, indicating when they are triggered by stress. The majority of weight loss apps are burdensome to users by requiring them to self-monitor diet and exercise. They also ignore major barriers to weight loss, such as stress. This work moves the field forward by addressing user burden and an important barrier to weight loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Dietary Self-Monitoring | Active Comparator | The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
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| Simple Dietary Self-Monitoring | Active Comparator | The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity | Behavioral | The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days App Used Over 12 Weeks | App use was measured for each condition using either backend data from Slip Buddy or reviewing MyFitnessPal entries indicating use over each 24-hour period. | 12 weeks |
| Usability | Usability will be assessed using the System Usability Scale (SUS), a 10-item measure with 5-point Likert scale response options (Strongly Agree to Strongly Disagree). Scores are summed (0-40) then converted to a 0-100 scale, with higher scores indicating higher usability. Scores above 58 are considered above average, and scores above 80 are considered to indicate high usability where participants are likely to recommend the product to friends. | 12 weeks |
| Acceptability | Acceptability was assessed with a single item at 12 weeks assessing perceived helpfulness of the assigned app: "Tracking my diet and exercise with MFP/slips with Slip Buddy was helpful" (responses on a 5-point Likert scale from strongly disagree to strongly agree). Acceptability was indicated by responses of agree or strongly agree. | 12 weeks |
| Burden | At 12 weeks, participants were asked how burdensome the task of using their assigned application was on a scale of 0-100, 0 being not at all burdensome and 100 being very burdensome. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change From Baseline to 12-Week Follow-Up | A digital scale (Fitbit Aria) will be used to record weight. Percent weight change was calculated using weight at baseline and weight at 12-week follow-up. Missing values were calculated using last carry forward (LOCF). | 12 weeks |
| Change in Perceived Stress From Baseline to 12-Week Follow-Up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33792547 | Derived | Pagoto S, Tulu B, Waring ME, Goetz J, Bibeau J, Divito J, Groshon L, Schroeder M. Slip Buddy App for Weight Management: Randomized Feasibility Trial of a Dietary Lapse Tracking App. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24249. doi: 10.2196/24249. |
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After participants were initially screened, a telephone screening, webinar orientation and baseline survey was required prior to being randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comprehensive Dietary Self-Monitoring | The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
| FG001 | Simple Dietary Self-Monitoring | The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Comprehensive Dietary Self-Monitoring | The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
| 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 | Percentage of Days App Used Over 12 Weeks | App use was measured for each condition using either backend data from Slip Buddy or reviewing MyFitnessPal entries indicating use over each 24-hour period. | Posted | Mean | Standard Deviation | percent of days app used | 12 weeks |
|
Adverse events were collected over the period of 12 weeks.
Adverse events were assessed during follow-up as well as documented when participants reported them during the intervention. Pregnancy was only assessed with female participants.
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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 | Comprehensive Dietary Self-Monitoring | The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight Gain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherry Pagoto | University of Connecticut | 8604868979 | 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 | Yes | No | No | Study Protocol | Mar 15, 2019 | Dec 10, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2020 | Dec 10, 2020 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2019 | Dec 22, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity | Behavioral | Arm: Active Comparator: Simple Dietary Self-Monitoring he intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
|
The Perceived Stress Scale is a 14-item measure of perceived stress. Scores range from 0-56, higher scores indicate higher perceived stress. |
| 12 weeks |
| Change in Emotional Eating From Baseline to 12-Week Follow-Up | Three-Factory Eating Inventory is an 18-item measure and the emotional eating subscale consists of 3 items on a 4-point Likert scale. The score is derived by a multi-step equation. The range of scores for this subscale is 0-100, higher scores indicate higher emotional eating. | 12 weeks |
| BG001 | Simple Dietary Self-Monitoring | The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | 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 |
|
| OG001 | Simple Dietary Self-Monitoring | The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments. |
|
|
| Primary | Usability | Usability will be assessed using the System Usability Scale (SUS), a 10-item measure with 5-point Likert scale response options (Strongly Agree to Strongly Disagree). Scores are summed (0-40) then converted to a 0-100 scale, with higher scores indicating higher usability. Scores above 58 are considered above average, and scores above 80 are considered to indicate high usability where participants are likely to recommend the product to friends. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
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| Primary | Acceptability | Acceptability was assessed with a single item at 12 weeks assessing perceived helpfulness of the assigned app: "Tracking my diet and exercise with MFP/slips with Slip Buddy was helpful" (responses on a 5-point Likert scale from strongly disagree to strongly agree). Acceptability was indicated by responses of agree or strongly agree. | Posted | Number | percentage of participants | 12 weeks |
|
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|
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| Primary | Burden | At 12 weeks, participants were asked how burdensome the task of using their assigned application was on a scale of 0-100, 0 being not at all burdensome and 100 being very burdensome. | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks |
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|
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| Secondary | Percent Weight Change From Baseline to 12-Week Follow-Up | A digital scale (Fitbit Aria) will be used to record weight. Percent weight change was calculated using weight at baseline and weight at 12-week follow-up. Missing values were calculated using last carry forward (LOCF). | Posted | Mean | Standard Deviation | percent weight | 12 weeks |
|
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| Secondary | Change in Perceived Stress From Baseline to 12-Week Follow-Up | The Perceived Stress Scale is a 14-item measure of perceived stress. Scores range from 0-56, higher scores indicate higher perceived stress. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Change in Emotional Eating From Baseline to 12-Week Follow-Up | Three-Factory Eating Inventory is an 18-item measure and the emotional eating subscale consists of 3 items on a 4-point Likert scale. The score is derived by a multi-step equation. The range of scores for this subscale is 0-100, higher scores indicate higher emotional eating. | Posted | Mean | Standard Deviation | change in score from baseline 12 weeks | 12 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 5 |
| 32 |
| EG001 | Simple Dietary Self-Monitoring | The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments. | 0 | 32 | 0 | 32 | 5 | 32 |
| Injury unrelated to exercise | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Assessed in females only |
|
| Flu | Immune system disorders | Non-systematic Assessment |
|
| Pulled Muscle During Exercise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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