An interventional study of Internet Only and Internet + Incentives in Obesity, sponsored by University of Vermont. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by University of Vermont · Not applicable, Interventional, and Treatment
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 418 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Internet Only
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.
Behavioral: Internet + Incentives
18 month behavioral weight loss intervention delivered online
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
Weight Change
Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.
Time frame: 6 months
Class Attendance
Average number of classes attended
Time frame: 6 months
Self Monitoring of Body Weight
Number of days with body weight self reported
Time frame: 6 months
Dietary Intake Self Monitoring
Number of days reported dietary intake over 6 months
Time frame: 6 months
Self Monitoring of Physical Activity
Number of days physical activity reported
Time frame: 6 months
Steps/Day
Number of Steps/day
Time frame: 6 months
| Milestone | Internet Only | Internet + Incentives |
|---|---|---|
| Started | 212 | 206 |
| Completed | 172 | 188 |
| Not completed | 40 | 18 |
| Withdrew: Pregnancy | 1 | 3 |
| Withdrew: Lost to follow-up | 38 | 15 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.
| kilograms | Internet Only | Internet + Incentives |
|---|---|---|
| Baseline | 97.8 ± 19.5 | 95.6 ± 15.9 |
| 6 Months | 4.7 ± 6.6 | 6.4 ± 5.5 |
Average number of classes attended
| Number of classes attended | Internet Only | Internet + Incentives |
|---|---|---|
| Class Attendance | 16 ± 6.6 | 18 ± 5.1 |
Number of days with body weight self reported
| Number of days weight self report | Internet Only | Internet + Incentives |
|---|---|---|
| Self Monitoring of Body Weight | 72 ± 51 | 115 ± 43 |
Number of days reported dietary intake over 6 months
| Number of days dietary intake reported | Internet Only | Internet + Incentives |
|---|---|---|
| Dietary Intake Self Monitoring | 85 ± 54 | 119 ± 44 |
Number of days physical activity reported
| Number of days Physical Activity report | Internet Only | Internet + Incentives |
|---|---|---|
| Self Monitoring of Physical Activity | 85 ± 54 | 118 ± 44 |
Number of Steps/day
| number of steps | Internet Only | Internet + Incentives |
|---|---|---|
| Steps/Day | 7447 ± 2888 | 8057 ± 2672 |
Collected over Adverse event data were collected from baseline through 6 months. There were no adverse or serious adverse events to report.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Internet Only | 0/212 (0%) | 0/212 (0%) | 0/212 (0%) |
| Internet + Incentives | 0/206 (0%) | 0/206 (0%) | 0/206 (0%) |
| Age, Continuous(years) | Internet Only | Internet + Incentives | Total |
|---|---|---|---|
| Mean | 48 ± 11.14 | 50 ± 11.01 | 49 ± 11.11 |
| Sex: Female, Male(Participants) | Internet Only | Internet + Incentives | Total |
|---|---|---|---|
| Female | 194 | 187 | 381 |
| Male | 18 | 19 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Internet Only | Internet + Incentives | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 210 | 202 | 412 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Internet Only | Internet + Incentives | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 63 | 44 | 107 |
| White | 147 | 160 | 307 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Internet Only | Internet + Incentives | Total |
|---|---|---|---|
| United States | 212 | 206 | 418 |
| Weight(kilograms) | Internet Only | Internet + Incentives | Total |
|---|---|---|---|
| Mean | 97.8 ± 19.5 | 95.6 ± 15.9 | 96.7 ± 17.7 |
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