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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL125669-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.
In this study, community outpatients will participate in an effective, 24-week, low-carbohydrate weight loss program delivered via biweekly group classes. An innovative information technology (IT) solution will collate dietary self-monitoring data (input by patients via a mobile phone dietary application) and weight loss data (input by patients via remote scale). An algorithm will classify participants as achieving adequate or inadequate dietary self-monitoring and weight loss to earn intermittent rewards of varying value in real-time. Participants will be notified of earning rewards via text messaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no incentives | No Intervention | Participants do not receive financial incentives. | |
| incentives for dietary self-monitoring | Active Comparator | Participants receive financial incentives for dietary self-monitoring. |
|
| incentives for interim weight loss | Active Comparator | Participants receive financial incentives for interim weight loss. |
|
| incentives for both | Experimental | Participants receive incentives for dietary self-monitoring and interim weight loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| incentives for dietary self-monitoring | Behavioral | Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change From Baseline to 24 Weeks | Measured in pounds | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan J Shaw, PhD, RN | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29289702 | Result | Voils CI, Levine E, Gierisch JM, Pendergast J, Hale SL, McVay MA, Reed SD, Yancy WS Jr, Bennett G, Strawbridge EM, White AC, Shaw RJ. Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity. Contemp Clin Trials. 2018 Feb;65:116-122. doi: 10.1016/j.cct.2017.12.007. Epub 2017 Dec 28. | |
| 37546286 | Derived | Gavin KL, Almeida EJ, Voils CI, Crane MM, Shaw R, Yancy WS Jr, Pendergast J, Olsen MK. Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method. Obes Sci Pract. 2023 Jan 12;9(4):337-345. doi: 10.1002/osp4.656. eCollection 2023 Aug. |
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| ID | Title | Description |
|---|---|---|
| FG000 | no Incentives | Participants do not receive financial incentives. |
| FG001 | Incentives for Dietary Self-monitoring | Participants receive financial incentives for dietary self-monitoring. incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application. |
| FG002 | Incentives for Interim Weight Loss | Participants receive financial incentives for interim weight loss. incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly. |
| FG003 | Incentives for Both | Participants receive incentives for dietary self-monitoring and interim weight loss. incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | no Incentives | Participants do not receive financial incentives. |
| BG001 | Incentives for Dietary Self-monitoring | Participants receive financial incentives for dietary self-monitoring. incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Change From Baseline to 24 Weeks | Measured in pounds | Posted | Mean | Standard Deviation | Pounds (lbs.) | 24 weeks |
|
6 months
Adverse events were also collected during in-person visits
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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 | no Incentives | Participants do not receive financial incentives. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment | Infected gallbladder removed. Preceding study: Diagnosed with IBS for 20 yrs, GERD longstanding, upper abdomen pains intermittently for >1year. Possible high fat diet was related. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swollen lymph node | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corrine Voils | University of Wisconsin-Madison | 608-262-9636 | voils@surgery.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2018 | May 15, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2018 | May 15, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| incentives for interim weight loss | Behavioral | Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly. |
|
| incentives for both | Behavioral | Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly. |
|
| 33245118 | Derived | Voils CI, Pendergast J, Hale SL, Gierisch JM, Strawbridge EM, Levine E, McVay MA, Reed SD, Yancy WS, Shaw RJ. A randomized feasibility pilot trial of a financial incentives intervention for dietary self-monitoring and weight loss in adults with obesity. Transl Behav Med. 2021 Apr 26;11(4):954-969. doi: 10.1093/tbm/ibaa102. |
| 30758297 | Derived | Shaw R, Levine E, Streicher M, Strawbridge E, Gierisch J, Pendergast J, Hale S, Reed S, McVay M, Simmons D, Yancy W, Bennett G, Voils C. Log2Lose: Development and Lessons Learned From a Mobile Technology Weight Loss Intervention. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11972. doi: 10.2196/11972. |
| BG002 | Incentives for Interim Weight Loss | Participants receive financial incentives for interim weight loss. incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly. |
| BG003 | Incentives for Both | Participants receive incentives for dietary self-monitoring and interim weight loss. incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants receive financial incentives for interim weight loss. incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly. |
| OG003 | Incentives for Both | Participants receive incentives for dietary self-monitoring and interim weight loss. incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly. |
|
|
| 26 |
| 1 |
| 26 |
| 3 |
| 26 |
| EG001 | Incentives for Dietary Self-monitoring | Participants receive financial incentives for dietary self-monitoring. incentives for dietary self-monitoring: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application. | 0 | 26 | 0 | 26 | 3 | 26 |
| EG002 | Incentives for Interim Weight Loss | Participants receive financial incentives for interim weight loss. incentives for interim weight loss: Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly. | 0 | 27 | 0 | 27 | 5 | 27 |
| EG003 | Incentives for Both | Participants receive incentives for dietary self-monitoring and interim weight loss. incentives for both: Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly. | 0 | 26 | 0 | 26 | 1 | 26 |
|
| Dog bite | Social circumstances | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Generally unwell | General disorders | Non-systematic Assessment | Felt weak, flushed and 'generally unwell'. Participant then decided to add carbs back into diet and stated that she felt better once she incorporated carbs back into her diet. |
|
| Gout like symptoms | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| ER visit for allergies | Immune system disorders | Non-systematic Assessment | Ate peanuts while traveling and irritated diverticulitis |
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| irritated diverticulitis | Gastrointestinal disorders | Non-systematic Assessment | Ate popcorn as snack, it irritated diverticulitis |
|
| Planned foot surgery | Social circumstances | Non-systematic Assessment | Weight adjustment 4 to 6 pound increase with cast consideration |
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| Bone achiness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| High blood pressure | Cardiac disorders | Systematic Assessment |
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| blood in urine | Renal and urinary disorders | Non-systematic Assessment | Pt stopped diet upon recommendation from physician |
|
| erythema | Immune system disorders | Non-systematic Assessment | erythema on facial areas. Participant experienced this before but flared up since beginning diet. |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |