Trial Outcomes & Findings for The Healthy Weigh Study (NCT NCT02878343)
NCT ID: NCT02878343
Last Updated: 2024-10-23
Results Overview
Change in mean weight (lbs.) from baseline to 18 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
344 participants
Primary outcome timeframe
Baseline to 18 months
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
Incentives
Daily lottery type incentives tied to achievement of weight loss goals
Incentives: Daily lottery type incentives tied to achievement of weight loss goals
|
Environmental Strategies
Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
Environmental strategies: Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
|
Incentive and Environmental Strategies
A combination of incentives and environmental strategies
Incentives: Daily lottery type incentives tied to achievement of weight loss goals
Environmental strategies: Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
|
Usual Care
Standard employee wellness benefits
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
86
|
86
|
|
Overall Study
COMPLETED
|
65
|
66
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
21
|
20
|
21
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Healthy Weigh Study
Baseline characteristics by cohort
| Measure |
Incentives
n=86 Participants
Daily lottery type incentives tied to achievement of weight loss goals
Incentives: Daily lottery type incentives tied to achievement of weight loss goals
|
Environmental Strategies
n=86 Participants
Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
Environmental strategies: Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
|
Incentive and Environmental Strategies
n=86 Participants
A combination of incentives and environmental strategies
Incentives: Daily lottery type incentives tied to achievement of weight loss goals
Environmental strategies: Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
|
Usual Care
n=86 Participants
Standard employee wellness benefits
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
86 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
344 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
46.6 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
44.9 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
44.6 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 10.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
247 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
97 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
172 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
138 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=99 Participants
|
86 participants
n=107 Participants
|
86 participants
n=206 Participants
|
86 participants
n=7 Participants
|
344 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to 18 monthsChange in mean weight (lbs.) from baseline to 18 months
Outcome measures
| Measure |
Incentives
n=86 Participants
Daily lottery type incentives tied to achievement of weight loss goals
Incentives: Daily lottery type incentives tied to achievement of weight loss goals
|
Environmental Strategies
n=86 Participants
Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
Environmental strategies: Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
|
Incentive and Environmental Strategies
n=86 Participants
A combination of incentives and environmental strategies
Incentives: Daily lottery type incentives tied to achievement of weight loss goals
Environmental strategies: Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
|
Usual Care
n=86 Participants
Standard employee wellness benefits
|
|---|---|---|---|---|
|
Mean Weight Change
|
-6.86 pounds
Standard Deviation 2.30
|
-6.86 pounds
Standard Deviation 2.08
|
-2.82 pounds
Standard Deviation 1.94
|
-0.66 pounds
Standard Deviation 1.69
|
Adverse Events
Incentives
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Environmental Strategies
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Incentive and Environmental Strategies
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Incentives
n=86 participants at risk
Daily lottery type incentives tied to achievement of weight loss goals
Incentives: Daily lottery type incentives tied to achievement of weight loss goals
|
Environmental Strategies
n=86 participants at risk
Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
Environmental strategies: Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
|
Incentive and Environmental Strategies
n=86 participants at risk
A combination of incentives and environmental strategies
Incentives: Daily lottery type incentives tied to achievement of weight loss goals
Environmental strategies: Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
|
Usual Care
n=86 participants at risk
Standard employee wellness benefits
|
|---|---|---|---|---|
|
Cardiac disorders
Aortic valve replacement
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
|
Injury, poisoning and procedural complications
Vehicular accident
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
|
General disorders
Headaches and dizziness
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
|
Cardiac disorders
Heart attack
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
|
Vascular disorders
Brain hemorrhage
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
0.00%
0/86 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the 18 month study period.
Definition does not differ from ct.gov definitions.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place