Trial Outcomes & Findings for The Weigh Forward, Financial Incentives for Maintenance of Weight Loss (NCT NCT02538783)
NCT ID: NCT02538783
Last Updated: 2019-01-14
Results Overview
Among participants who lost 5 kg or more of baseline weight prior to randomization, assess the effectiveness of escalating lottery rewards, relative to the control group, on maintenance of weight loss after 6 months of intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
259 participants
Primary outcome timeframe
6 months
Results posted on
2019-01-14
Participant Flow
Participant milestones
| Measure |
Control
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
|
Escalating Lottery
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.
Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
129
|
|
Overall Study
COMPLETED
|
130
|
128
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Weigh Forward, Financial Incentives for Maintenance of Weight Loss
Baseline characteristics by cohort
| Measure |
Control
n=130 Participants
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
|
Escalating Lottery
n=128 Participants
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.
Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
|
Total
n=258 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
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
49.2 Years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
46.9 Years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
48 Years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
243 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
235 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Education
High School or less
|
22 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Education
Some college
|
42 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Education
College degree
|
33 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Education
Post graduate
|
33 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Income
<$50,000
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Income
$50,000 to $99,000
|
62 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Income
$100,000 to $149,000
|
41 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Income
>=$150,000
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Household Size
|
2.8 people per household
STANDARD_DEVIATION 1.3 • n=99 Participants
|
3.2 people per household
STANDARD_DEVIATION 1.6 • n=107 Participants
|
3 people per household
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
BMI at randomization
|
31.7 kg/m^2
STANDARD_DEVIATION 3.7 • n=99 Participants
|
32.6 kg/m^2
STANDARD_DEVIATION 4.2 • n=107 Participants
|
32.1 kg/m^2
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
Weight loss prior to randomization
|
11.5 kilograms
STANDARD_DEVIATION 4.3 • n=99 Participants
|
11.8 kilograms
STANDARD_DEVIATION 4.1 • n=107 Participants
|
11.6 kilograms
STANDARD_DEVIATION 4.2 • n=206 Participants
|
|
Willing to give up something today in order to benefit in the future
Most averse to risks
|
44 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Willing to give up something today in order to benefit in the future
Moderate averse to risks
|
70 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Willing to give up something today in order to benefit in the future
Least averse to risks
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Postpone things even though it would be better to get done right away
Most averse to risks
|
44 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Postpone things even though it would be better to get done right away
Moderate averse to risks
|
70 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Postpone things even though it would be better to get done right away
Least averse to risks
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Baseline IPAQ Level
Low
|
20 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Baseline IPAQ Level
Moderate
|
52 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Baseline IPAQ Level
High
|
58 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Baseline IPAQ Level
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Baseline MVPA minutes/week
|
180 Minutes per week
n=99 Participants
|
145 Minutes per week
n=107 Participants
|
150 Minutes per week
n=206 Participants
|
|
Baseline Walking minutes/week
|
210 Minutes per week
n=99 Participants
|
210 Minutes per week
n=107 Participants
|
210 Minutes per week
n=206 Participants
|
|
Eating behaviors by Three Factor Questionnaire
Baseline cognitive restraint
|
63.2 scores on a scale
STANDARD_DEVIATION 12.9 • n=99 Participants
|
64.1 scores on a scale
STANDARD_DEVIATION 15.6 • n=107 Participants
|
63.7 scores on a scale
STANDARD_DEVIATION 14.3 • n=206 Participants
|
|
Eating behaviors by Three Factor Questionnaire
Baseline uncontrolled eating
|
41.8 scores on a scale
STANDARD_DEVIATION 17.9 • n=99 Participants
|
42.7 scores on a scale
STANDARD_DEVIATION 17.9 • n=107 Participants
|
42.2 scores on a scale
STANDARD_DEVIATION 17.9 • n=206 Participants
|
|
Eating behaviors by Three Factor Questionnaire
Baseline emotional eating
|
51.4 scores on a scale
STANDARD_DEVIATION 25.4 • n=99 Participants
|
53.9 scores on a scale
STANDARD_DEVIATION 24.5 • n=107 Participants
|
52.6 scores on a scale
STANDARD_DEVIATION 24.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAmong participants who lost 5 kg or more of baseline weight prior to randomization, assess the effectiveness of escalating lottery rewards, relative to the control group, on maintenance of weight loss after 6 months of intervention
Outcome measures
| Measure |
Control
n=130 Participants
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
|
Escalating Lottery
n=128 Participants
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.
Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Change in Weight, Baseline and 6 Months
|
-1.9 Kilograms
Standard Deviation 5.9
|
-1.1 Kilograms
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: 12 monthsAmong participants who lost 5 kg or more of baseline weight prior to randomization, assess the degree to which weight loss is maintained in the intervention groups relative to usual care during the 6 months following the cessation of the interventions
Outcome measures
| Measure |
Control
n=130 Participants
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
|
Escalating Lottery
n=128 Participants
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.
Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Change in Weight, 6 Months and 12 Months
|
-0.6 Kilograms
Standard Deviation 8.2
|
0.2 Kilograms
Standard Deviation 8.1
|
Adverse Events
Control
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Escalating Lottery
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=130 participants at risk
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
|
Escalating Lottery
n=129 participants at risk
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.
Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Immune system disorders
Diagnosis of multiple sclerosis
|
0.77%
1/130 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
0.78%
1/129 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/130 • Adverse events were collected for 1 year (length of time in study).
|
0.78%
1/129 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue sarcoma
|
0.00%
0/130 • Adverse events were collected for 1 year (length of time in study).
|
0.78%
1/129 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
|
Infections and infestations
Pneumonia
|
0.77%
1/130 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
0.00%
0/129 • Adverse events were collected for 1 year (length of time in study).
|
|
Infections and infestations
Ankle infection
|
0.77%
1/130 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
0.00%
0/129 • Adverse events were collected for 1 year (length of time in study).
|
|
Surgical and medical procedures
Hysterectomy
|
0.77%
1/130 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
0.00%
0/129 • Adverse events were collected for 1 year (length of time in study).
|
|
Surgical and medical procedures
Full right hip replacement
|
0.77%
1/130 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
0.00%
0/129 • Adverse events were collected for 1 year (length of time in study).
|
Other adverse events
| Measure |
Control
n=130 participants at risk
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.
|
Escalating Lottery
n=129 participants at risk
Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.
Escalating Lottery: Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Knee injury
|
0.00%
0/130 • Adverse events were collected for 1 year (length of time in study).
|
0.78%
1/129 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
|
Surgical and medical procedures
Outpatient foot surgery
|
0.77%
1/130 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
0.00%
0/129 • Adverse events were collected for 1 year (length of time in study).
|
|
Surgical and medical procedures
Outpatient knee surgery
|
1.5%
2/130 • Number of events 2 • Adverse events were collected for 1 year (length of time in study).
|
0.00%
0/129 • Adverse events were collected for 1 year (length of time in study).
|
|
Surgical and medical procedures
Outpatient hernia surgery
|
0.00%
0/130 • Adverse events were collected for 1 year (length of time in study).
|
0.78%
1/129 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
|
Surgical and medical procedures
Outpatient bladder and rectum repair surgery
|
0.77%
1/130 • Number of events 1 • Adverse events were collected for 1 year (length of time in study).
|
0.00%
0/129 • Adverse events were collected for 1 year (length of time in study).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place