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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK118957 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Economics intervention (BE mHealth) | Experimental | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. |
|
| Standard mHealth intervention (mHealth) | Active Comparator | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Economics intervention (BE mHealth) | Behavioral | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight change measured on a digital scale to the nearest 0.1-kilogram | Baseline, 2 month, 6 month, 12 month, 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tricia Leahey, PhD | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Weight Management Research Lab | Hartford | Connecticut | 06103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Economics Intervention (BE mHealth) | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. Behavioral Economics intervention (BE mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. |
| FG001 | Standard mHealth Intervention (mHealth) | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Economics Intervention (BE mHealth) | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. Behavioral Economics intervention (BE mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. |
| 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 | Weight | Weight change measured on a digital scale to the nearest 0.1-kilogram | There was attrition over time during this longitudinal study, such that more participants were lost to follow-up over time. | Posted | Mean | Standard Deviation | kg | Baseline, 2 month, 6 month, 12 month, 18 months |
|
Adverse event data were collected over 12 months.
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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 Economics Intervention (BE mHealth) | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. Behavioral Economics intervention (BE mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID - long/severe | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of Connecticut | 8604862834 | tricia.leahey@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 17, 2025 | Dec 17, 2025 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Standard mHealth intervention (mHealth) | Behavioral | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). |
|
| BG001 | Standard mHealth Intervention (mHealth) | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Body Mass Index (BMI; kg/m2) | Weight was assessed objectively via digital scale; height is based on participant's self-report; BMI was calculated using the formula weight in kg / height in m2. | Mean | Standard Deviation | kg/m2 |
|
| Standard mHealth Intervention (mHealth) |
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). |
|
|
| 0 |
| 97 |
| 3 |
| 97 |
| 7 |
| 97 |
| EG001 | Standard mHealth Intervention (mHealth) | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). | 0 | 98 | 6 | 98 | 5 | 98 |
| Hospitalization | Nervous system disorders | Systematic Assessment |
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| Hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hospitalization | Cardiac disorders | Systematic Assessment |
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| Hospitalization | Gastrointestinal disorders | Systematic Assessment |
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| Gall Bladder | Gastrointestinal disorders | Systematic Assessment |
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| Break/Bad Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Back issues | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |