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This study will test the effectiveness of a mobile application that uses an Application Program Interface (API) to distribute evidence-based weight loss interventions. Half of the participants will receive this API-based application, and the other half of the participants will use a non API-based application.
The purpose of this study is to test a weight loss app that uses an API to disseminate an evidence-based weight loss intervention. The investigators hypothesize that, over the course of 12 months, participants using the Leaner app will have lost more weight than those in the attention control group.
Participants (n=206) will be randomly assigned to use either the intervention app (intervention arm; n=103) or a weight loss app of their choosing (attention control arm; n=103) for 12 months. Assessments will take place at baseline, and 3, 6, and 12 months.
Statistical analysis: A linear mixed modeling approach will be used to test the hypothesis. Observed weight vs. time plots will be analyzed for all participants to discern general trends in weight change. The model will include an intervention effect, a time effect, an intervention by time interaction, and a random intercept.
In exploratory analysis, investigators will examine weight change across subgroups of interest; investigators will add the subgroup variable and its interaction with the intervention indicator to the primary model. All analyses will be evaluated at the 0.05 significance level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| API App | Experimental | use of API weight loss mobile application for 12 months, plus fitness tracker and scale. |
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| Attention Control | Active Comparator | use of non-API app for weight loss over 12 months, plus fitness tracker and scale. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| API App | Behavioral | Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Change in body weight over course of study | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change - 3 months | Initial weight change | up to 3 months |
| Weight Change - 6 months | mid-point weight change | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coeus Health Offices | State College | Pennsylvania | 16801 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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Participants will not know which arm they have been randomized to. Additionally, the investigators will be blinded to participant assignment. Randomization will be completed by the program manager.
| Non-API App | Behavioral | Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale. |
|
| fitness tracker | Behavioral | fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app |
|
|
| scale | Behavioral | Connected scale that will transfer weight information to app |
|
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| Automated Self-Administered 24-hour Dietary recall (ASA-24) | Dietary patterns/24-hour dietary recall | baseline, 3-, 6-, 12-months |
| Physical Activity | Paffenbarger survey to capture physical activity patterns. Assesses self-report leisure time physical activity and weekly kilocalorie expenditure. | baseline, 3-, 6-, 12-months |
| Blood Pressure | Using a blood pressure cuff, measured three times at 1-minute intervals after 5 minutes of quiet sitting. Average of final two measurements is used. | baseline, 3-, 6-, 12-months |
| Fasting Lipid Profile | finger stick blood samples will be collected, following an overnight fast, to analyze fasting lipid profile. Samples will be analyzed using the Cholestech LDX | baseline, 3-, 6-, 12-months |
| Plasma Glucose | finger stick blood samples will be collected, following an overnight fast, to analyze plasma glucose. Samples will be analyzed using the Cholestech LDX | baseline, 3-, 6-, 12-months |
| High Sensitivity C-Reactive Protein | finger stick blood samples will be collected, following an overnight fast, to analyze high sensitivity c-reactive protein. Samples will be analyzed using the Cholestech LDX | baseline, 3-, 6-, 12-months |
| Patient Health Questionnaire (PHQ) 9 | Nine-item self-report assessment of depression severity. | baseline, 3-, 6-, 12-months |
| Body Shape Questionnaire (BSQ) | 8-item self-report questionnaire about concern with body shape. | baseline, 3-, 6-, 12-months |
| Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R) | 24-item self-report measure of disordered eating cognitions. | baseline, 3-, 6-, 12-months |
| Questionnaire of Eating and Weight Patterns | Eight-item self-report measure of binge eating behaviors. | baseline, 3-, 6-, 12-months |
| Medical Outcomes Survey: Social Support | 19-item self-report assessment of social support. | baseline, 3-, 6-, 12-months |
| EuroQOL Health Related Quality of Life Scale | 16-item self-report assessment of health related quality of life. | baseline, 3-, 6-, 12-months |
| The Health and Work Performance Questionnaire (HPQ) | Presenteeism/Absenteeism items from the self-report HPQ. | baseline, 3-, 6-, 12-months |
| App engagement | Using technology on smart phones, we will monitor participants' app usage throughout the course of the study. | through study completion, an average of 1 year |
| D001519 | Behavior |
| D008919 | Investigative Techniques |