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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK056746 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of South Carolina | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The investigators propose a randomized controlled trial to evaluate whether the addition of financial incentives to a high-quality, online behavioral weight loss intervention produces better weight losses than the online treatment alone.
Overweight and obese but otherwise healthy participants (N=416) will be recruited in approximately equal numbers at two clinical centers, the University of South Carolina and the University of Vermont. Eligible participants will be randomized to one of two conditions: 1) an 18-month, 36-session group Internet behavioral weight control treatment (Internet Only) which replicates the intervention the investigators have implemented previously; or 2) the same 18-month, 36-session group Internet treatment plus financial incentives for performance of 3 key self-management behaviors (Internet+ Incentive). Both conditions will have access to the same web-based intervention platform and the same counselor-delivered intervention elements; the presence of economic incentives for behavioral and weight goals is the only difference between the conditions. Assessments will be conducted at Baseline, 2, 6, 12 and 18 months. Cost data will be collected to inform cost effectiveness evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet only | Active Comparator | Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. |
|
| Internet + Incentives | Experimental | Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet Only | Behavioral | 18 month behavioral weight loss intervention delivered online |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Class Attendance | Average number of classes attended | 6 months |
| Self Monitoring of Body Weight | Number of days with body weight self reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Delia Smith West, PhD | University of South Carolina | Principal Investigator |
| Jean R Harvey, PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States | ||
| Behavioral Weight Management Program/Univ of Vermont |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35089159 | Derived | Stansbury ML, Harvey J, Krukowski RA, Pellegrini CA, Wang X, West DS. Describing Transitions in Adherence to Physical Activity Self-monitoring and Goal Attainment in an Online Behavioral Weight Loss Program: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Jan 28;24(1):e30673. doi: 10.2196/30673. | |
| 34932889 | Derived | West DS, Krukowski RA, Monroe CM, Stansbury ML, Carpenter CA, Finkelstein EA, Naud S, Ogden D, Harvey JR. Randomized controlled trial of financial incentives during weight-loss induction and maintenance in online group weight control. Obesity (Silver Spring). 2022 Jan;30(1):106-116. doi: 10.1002/oby.23322. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Internet Only | Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online |
| FG001 | Internet + Incentives | Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Internet Only | Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 18 month behavioral weight loss intervention delivered online |
| 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 Change | Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline. | Posted | Mean | Standard Deviation | kilograms | 6 months |
|
Adverse event data were collected from baseline through 6 months. There were no adverse or serious adverse events to report.
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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 | Internet Only | Participants will be required to attend a weekly Internet chat session with your group members and one of the behavioral weight control therapists. Participants will learn the principles of managing eating and exercise behaviors in weekly, hour-long chat sessions and by completing weekly lessons. Participants are asked to self-monitor foods and exercise through the use of a smartphone ap. Participants will wear a tracking device that monitors steps. All participants will be contacted via e-mail individually, by their group leader who will monitor their progress and offer advice and encouragement. Meetings are weekly for 24 weeks and monthly for 12 months. Internet Only: 6 month behavioral weight loss intervention delivered online |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doris Ogden | University of Vermont | 802-656-1960 | doris.ogden@uvm.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 | Feb 6, 2015 | Nov 17, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 4, 2015 | Jun 16, 2020 | ICF_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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| Internet + Incentives |
| Behavioral |
18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing |
|
| 6 months |
| Dietary Intake Self Monitoring | Number of days reported dietary intake over 6 months | 6 months |
| Self Monitoring of Physical Activity | Number of days physical activity reported | 6 months |
| Steps/Day | Number of Steps/day | 6 months |
| Burlington |
| Vermont |
| 05405 |
| United States |
| 32446752 | Derived | West DS, Krukowski RA, Finkelstein EA, Stansbury ML, Ogden DE, Monroe CM, Carpenter CA, Naud S, Harvey JR. Adding Financial Incentives to Online Group-Based Behavioral Weight Control: An RCT. Am J Prev Med. 2020 Aug;59(2):237-246. doi: 10.1016/j.amepre.2020.03.015. Epub 2020 May 21. |
| Withdrawal by Subject |
|
| BG001 | Internet + Incentives | Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing |
| BG002 | Total | Total of all reporting groups |
| 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 | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| OG001 | Internet + Incentives | Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing |
|
|
|
| Secondary | Class Attendance | Average number of classes attended | Posted | Mean | Standard Deviation | Number of classes attended | 6 months |
|
|
|
| Secondary | Self Monitoring of Body Weight | Number of days with body weight self reported | Posted | Mean | Standard Deviation | Number of days weight self report | 6 months |
|
|
|
| Secondary | Dietary Intake Self Monitoring | Number of days reported dietary intake over 6 months | Posted | Mean | Standard Deviation | Number of days dietary intake reported | 6 months |
|
|
|
| Secondary | Self Monitoring of Physical Activity | Number of days physical activity reported | Posted | Mean | Standard Deviation | Number of days Physical Activity report | 6 months |
|
|
|
| Secondary | Steps/Day | Number of Steps/day | Posted | Mean | Standard Deviation | number of steps | 6 months |
|
|
|
| 0 |
| 212 |
| 0 |
| 212 |
| 0 |
| 212 |
| EG001 | Internet + Incentives | Participants are given the same intervention as described for the internet only group, with the exception that they will have the opportunity to earn financial incentives. Financial incentives will be based on participants weight loss, and compliance with certain weight loss behaviors including meeting exercise goals, self-monitoring foods consumed, and daily weighing and reporting. Internet + Incentives: 6 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing | 0 | 206 | 0 | 206 | 0 | 206 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |