Trial Outcomes & Findings for Incentivizing Behavior Change Skills to Promote Weight Loss (NCT NCT02691260)
NCT ID: NCT02691260
Last Updated: 2019-08-05
Results Overview
Measured in pounds
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-08-05
Participant Flow
Participant milestones
| Measure |
no Incentives
Participants do not receive financial incentives.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
27
|
26
|
|
Overall Study
COMPLETED
|
24
|
24
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Incentivizing Behavior Change Skills to Promote Weight Loss
Baseline characteristics by cohort
| Measure |
no Incentives
n=26 Participants
Participants do not receive financial incentives.
|
Incentives for Dietary Self-monitoring
n=26 Participants
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.
|
Incentives for Interim Weight Loss
n=27 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.
|
Incentives for Both
n=26 Participants
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.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
92 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Age, Continuous
|
49.65 years
STANDARD_DEVIATION 12.73 • n=93 Participants
|
51.27 years
STANDARD_DEVIATION 15.46 • n=4 Participants
|
46.44 years
STANDARD_DEVIATION 11.15 • n=27 Participants
|
45.92 years
STANDARD_DEVIATION 12.84 • n=483 Participants
|
48.3 years
STANDARD_DEVIATION 13.12 • n=36 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
92 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
102 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
33 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
64 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
105 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 24 weeksMeasured in pounds
Outcome measures
| Measure |
no Incentives
n=24 Participants
Participants do not receive financial incentives.
|
Incentives for Dietary Self-monitoring
n=24 Participants
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.
|
Incentives for Interim Weight Loss
n=25 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.
|
Incentives for Both
n=23 Participants
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.
|
|---|---|---|---|---|
|
Weight Change From Baseline to 24 Weeks
|
-8.046 Pounds (lbs.)
Standard Deviation 13.316
|
-15.496 Pounds (lbs.)
Standard Deviation 15.391
|
-12.167 Pounds (lbs.)
Standard Deviation 17.884
|
-17.696 Pounds (lbs.)
Standard Deviation 10.312
|
Adverse Events
no Incentives
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Incentives for Dietary Self-monitoring
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Incentives for Interim Weight Loss
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Incentives for Both
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
no Incentives
n=26 participants at risk
Participants do not receive financial incentives.
|
Incentives for Dietary Self-monitoring
n=26 participants at risk
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.
|
Incentives for Interim Weight Loss
n=27 participants at risk
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.
|
Incentives for Both
n=26 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
3.8%
1/26 • Number of events 26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/27 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
Other adverse events
| Measure |
no Incentives
n=26 participants at risk
Participants do not receive financial incentives.
|
Incentives for Dietary Self-monitoring
n=26 participants at risk
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.
|
Incentives for Interim Weight Loss
n=27 participants at risk
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.
|
Incentives for Both
n=26 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Swollen lymph node
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
3.7%
1/27 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Social circumstances
Dog bite
|
3.8%
1/26 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/27 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
3.7%
1/27 • Number of events 2 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
General disorders
Generally unwell
|
3.8%
1/26 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/27 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Metabolism and nutrition disorders
Gout like symptoms
|
3.8%
1/26 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/27 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Immune system disorders
ER visit for allergies
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
3.8%
1/26 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/27 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Gastrointestinal disorders
irritated diverticulitis
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
3.8%
1/26 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/27 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Social circumstances
Planned foot surgery
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/27 • 6 months
Adverse events were also collected during in-person visits
|
3.8%
1/26 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
|
Musculoskeletal and connective tissue disorders
Bone achiness
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
3.7%
1/27 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Cardiac disorders
High blood pressure
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
3.7%
1/27 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Renal and urinary disorders
blood in urine
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
3.7%
1/27 • Number of events 1 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
|
Immune system disorders
erythema
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
3.8%
1/26 • Number of events 3 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/27 • 6 months
Adverse events were also collected during in-person visits
|
0.00%
0/26 • 6 months
Adverse events were also collected during in-person visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place