Trial Outcomes & Findings for Financial Incentives for Maintenance of Weight Loss (NCT NCT01900392)

NCT ID: NCT01900392

Last Updated: 2018-09-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 191 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-09-27

Participant Flow

Participant milestones

Measure	Control Arm No other financial incentive other than for the 3-, 6-, 9-, \& 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.	Direct Payment In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required. Financial incentive: Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.	Lottery In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.
Overall Study STARTED	39	75	77
Overall Study COMPLETED	38	74	77
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Financial Incentives for Maintenance of Weight Loss

Baseline characteristics by cohort

Measure	Lottery n=77 Participants In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.	Direct Payment n=75 Participants In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings.	Control n=39 Participants No other financial incentive other than for the 3-, 6-, 9-, \& 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.	Total n=191 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 10.3 • n=5 Participants	48.6 years STANDARD_DEVIATION 11.0 • n=7 Participants	50.1 years STANDARD_DEVIATION 10.0 • n=5 Participants	49.0 years STANDARD_DEVIATION 10.5 • n=4 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	69 Participants n=7 Participants	36 Participants n=5 Participants	175 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants	71 Participants n=7 Participants	37 Participants n=5 Participants	183 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	69 Participants n=7 Participants	33 Participants n=5 Participants	170 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Household income <US $50,000	12 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Household income US $50,000 to <US $100,000	36 Participants n=5 Participants	40 Participants n=7 Participants	20 Participants n=5 Participants	96 Participants n=4 Participants
Household income ≥US $100,000	29 Participants n=5 Participants	30 Participants n=7 Participants	13 Participants n=5 Participants	72 Participants n=4 Participants
Household size	3.2 people per household STANDARD_DEVIATION 1.5 • n=5 Participants	3.0 people per household STANDARD_DEVIATION 1.4 • n=7 Participants	3.0 people per household STANDARD_DEVIATION 1.2 • n=5 Participants	3.1 people per household STANDARD_DEVIATION 1.4 • n=4 Participants
Education Less than college	26 participants n=5 Participants	35 participants n=7 Participants	11 participants n=5 Participants	72 participants n=4 Participants
Education College graduate	28 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants	55 participants n=4 Participants
Education Post-college degree	23 participants n=5 Participants	29 participants n=7 Participants	12 participants n=5 Participants	64 participants n=4 Participants
Weight measures Weight at the start of Weight Watchers	100.8 Kilograms STANDARD_DEVIATION 15.7 • n=5 Participants	101.7 Kilograms STANDARD_DEVIATION 16.0 • n=7 Participants	102.9 Kilograms STANDARD_DEVIATION 15.6 • n=5 Participants	101.6 Kilograms STANDARD_DEVIATION 15.7 • n=4 Participants
Weight measures Weight at randomization	89.2 Kilograms STANDARD_DEVIATION 14.3 • n=5 Participants	90.7 Kilograms STANDARD_DEVIATION 15.7 • n=7 Participants	91.2 Kilograms STANDARD_DEVIATION 15.0 • n=5 Participants	90.2 Kilograms STANDARD_DEVIATION 14.9 • n=4 Participants
Weight measures Weight loss prior to randomization	11.6 Kilograms STANDARD_DEVIATION 4.4 • n=5 Participants	10.9 Kilograms STANDARD_DEVIATION 5.1 • n=7 Participants	11.7 Kilograms STANDARD_DEVIATION 4.3 • n=5 Participants	11.4 Kilograms STANDARD_DEVIATION 4.7 • n=4 Participants
BMI measures BMI at start of Weight Watchers	36.5 kg/m^2 STANDARD_DEVIATION 4.4 • n=5 Participants	36.8 kg/m^2 STANDARD_DEVIATION 4.1 • n=7 Participants	36.9 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants	36.7 kg/m^2 STANDARD_DEVIATION 4.3 • n=4 Participants
BMI measures BMI at randomization	32.3 kg/m^2 STANDARD_DEVIATION 4.1 • n=5 Participants	32.8 kg/m^2 STANDARD_DEVIATION 4.3 • n=7 Participants	32.6 kg/m^2 STANDARD_DEVIATION 4.1 • n=5 Participants	32.5 kg/m^2 STANDARD_DEVIATION 4.1 • n=4 Participants
BMI ≥35 kg/m2 at randomization	26 Participants n=5 Participants	29 Participants n=7 Participants	14 Participants n=5 Participants	69 Participants n=4 Participants
Eating behaviors by Three-Factor Eating Questionnaire Cognitive restraint scale	62.0 Scores on a scale STANDARD_DEVIATION 15.0 • n=5 Participants	62.6 Scores on a scale STANDARD_DEVIATION 14.6 • n=7 Participants	62.4 Scores on a scale STANDARD_DEVIATION 12.8 • n=5 Participants	62.3 Scores on a scale STANDARD_DEVIATION 14.4 • n=4 Participants
Eating behaviors by Three-Factor Eating Questionnaire Uncontrolled eating scale	44.4 Scores on a scale STANDARD_DEVIATION 15.6 • n=5 Participants	47.6 Scores on a scale STANDARD_DEVIATION 16.2 • n=7 Participants	41.8 Scores on a scale STANDARD_DEVIATION 16.1 • n=5 Participants	45.1 Scores on a scale STANDARD_DEVIATION 16.0 • n=4 Participants
Eating behaviors by Three-Factor Eating Questionnaire Emotional eating scale	58.7 Scores on a scale STANDARD_DEVIATION 23.8 • n=5 Participants	63.3 Scores on a scale STANDARD_DEVIATION 23.5 • n=7 Participants	55.8 Scores on a scale STANDARD_DEVIATION 27.2 • n=5 Participants	59.9 Scores on a scale STANDARD_DEVIATION 24.5 • n=4 Participants
Physical activity in min per week Moderate-vigorous activity min per week	345 Minutes n=5 Participants	240 Minutes n=7 Participants	390 Minutes n=5 Participants	333 Minutes n=4 Participants
Physical activity in min per week Walking min per week	180 Minutes n=5 Participants	100 Minutes n=7 Participants	150 Minutes n=5 Participants	148 Minutes n=4 Participants
Physical activity in min per week Total activity min per week	533 Minutes n=5 Participants	460 Minutes n=7 Participants	600 Minutes n=5 Participants	510 Minutes n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Lottery n=77 Participants In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.	Control Arm n=38 Participants No other financial incentive other than for the 3-, 6-, 9-, \& 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.	Direct Payment n=74 Participants In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required. Financial incentive: Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
Change in Weight From Baseline to 6 Months	-3.0 kilograms Standard Deviation 5.8	-1.4 kilograms Standard Deviation 5.8	-2.8 kilograms Standard Deviation 5.8

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Lottery n=77 Participants In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.	Control Arm n=38 Participants No other financial incentive other than for the 3-, 6-, 9-, \& 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.	Direct Payment n=74 Participants In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required. Financial incentive: Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
Change in Weight From Baseline to 12 Months	-2.0 kilograms Standard Deviation 17.9	2.8 kilograms Standard Deviation 16.9	-2.2 kilograms Standard Deviation 16.2

Adverse Events

Lottery

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Direct Payment

Serious events: 9 serious events

Other events: 1 other events

Deaths: 1 deaths

Control

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lottery n=77 participants at risk In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.	Direct Payment n=75 participants at risk In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.	Control n=39 participants at risk No other financial incentive other than for the 3-, 6-, 9-, \& 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.
Reproductive system and breast disorders Hysterectomy	1.3% 1/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Surgical and medical procedures Hip replacement	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	2.6% 1/39 • 1 year
Injury, poisoning and procedural complications Concussion	0.00% 0/77 • 1 year	0.00% 0/75 • 1 year	2.6% 1/39 • 1 year
Nervous system disorders Brain aneurysm	0.00% 0/77 • 1 year	0.00% 0/75 • 1 year	2.6% 1/39 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/77 • 1 year	0.00% 0/75 • 1 year	2.6% 1/39 • 1 year
Gastrointestinal disorders Ruptured appendix	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Surgical and medical procedures Temporal artery biopsy	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Vascular disorders Lymphoma	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Cardiac disorders Syncope	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Cardiac disorders Angina	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Nervous system disorders Migraine	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Reproductive system and breast disorders Breast cancer	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Surgical and medical procedures Vascular surgery	1.3% 1/77 • 1 year	0.00% 0/75 • 1 year	0.00% 0/39 • 1 year

Other adverse events

Measure	Lottery n=77 participants at risk In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.	Direct Payment n=75 participants at risk In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.	Control n=39 participants at risk No other financial incentive other than for the 3-, 6-, 9-, \& 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.
Surgical and medical procedures Ganglion cyst outpatient surgery	0.00% 0/77 • 1 year	0.00% 0/75 • 1 year	2.6% 1/39 • 1 year
Injury, poisoning and procedural complications Sciatica from car accident	0.00% 0/77 • 1 year	1.3% 1/75 • 1 year	0.00% 0/39 • 1 year
Injury, poisoning and procedural complications Broken foot	1.3% 1/77 • 1 year	0.00% 0/75 • 1 year	0.00% 0/39 • 1 year
Injury, poisoning and procedural complications Torn ACL and MCL, broken ankle	1.3% 1/77 • 1 year	0.00% 0/75 • 1 year	0.00% 0/39 • 1 year

Additional Information

Catherine Reale

UPENN

Phone: 2157464009

Email: catherine.reale@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place