Trial Outcomes & Findings for The Weigh Forward, Financial Incentives for Maintenance of Weight Loss (NCT 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

Target enrollment

259 participants

Primary outcome timeframe

6 months

Results posted on

2019-01-14

Participant Flow

Participant milestones

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

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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants	124 Participants n=7 Participants	246 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	49.2 Years STANDARD_DEVIATION 10.6 • n=5 Participants	46.9 Years STANDARD_DEVIATION 10.2 • n=7 Participants	48 Years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	112 Participants n=7 Participants	225 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	121 Participants n=5 Participants	122 Participants n=7 Participants	243 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	120 Participants n=5 Participants	115 Participants n=7 Participants	235 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Education High School or less	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Education Some college	42 Participants n=5 Participants	34 Participants n=7 Participants	76 Participants n=5 Participants
Education College degree	33 Participants n=5 Participants	41 Participants n=7 Participants	74 Participants n=5 Participants
Education Post graduate	33 Participants n=5 Participants	42 Participants n=7 Participants	75 Participants n=5 Participants
Income <$50,000	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Income $50,000 to $99,000	62 Participants n=5 Participants	65 Participants n=7 Participants	127 Participants n=5 Participants
Income $100,000 to $149,000	41 Participants n=5 Participants	35 Participants n=7 Participants	76 Participants n=5 Participants
Income >=$150,000	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Household Size	2.8 people per household STANDARD_DEVIATION 1.3 • n=5 Participants	3.2 people per household STANDARD_DEVIATION 1.6 • n=7 Participants	3 people per household STANDARD_DEVIATION 1.4 • n=5 Participants
BMI at randomization	31.7 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants	32.6 kg/m^2 STANDARD_DEVIATION 4.2 • n=7 Participants	32.1 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants
Weight loss prior to randomization	11.5 kilograms STANDARD_DEVIATION 4.3 • n=5 Participants	11.8 kilograms STANDARD_DEVIATION 4.1 • n=7 Participants	11.6 kilograms STANDARD_DEVIATION 4.2 • n=5 Participants
Willing to give up something today in order to benefit in the future Most averse to risks	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants
Willing to give up something today in order to benefit in the future Moderate averse to risks	70 Participants n=5 Participants	65 Participants n=7 Participants	135 Participants n=5 Participants
Willing to give up something today in order to benefit in the future Least averse to risks	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Postpone things even though it would be better to get done right away Most averse to risks	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants
Postpone things even though it would be better to get done right away Moderate averse to risks	70 Participants n=5 Participants	65 Participants n=7 Participants	135 Participants n=5 Participants
Postpone things even though it would be better to get done right away Least averse to risks	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Baseline IPAQ Level Low	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Baseline IPAQ Level Moderate	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Baseline IPAQ Level High	58 Participants n=5 Participants	44 Participants n=7 Participants	102 Participants n=5 Participants
Baseline IPAQ Level Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Baseline MVPA minutes/week	180 Minutes per week n=5 Participants	145 Minutes per week n=7 Participants	150 Minutes per week n=5 Participants
Baseline Walking minutes/week	210 Minutes per week n=5 Participants	210 Minutes per week n=7 Participants	210 Minutes per week n=5 Participants
Eating behaviors by Three Factor Questionnaire Baseline cognitive restraint	63.2 scores on a scale STANDARD_DEVIATION 12.9 • n=5 Participants	64.1 scores on a scale STANDARD_DEVIATION 15.6 • n=7 Participants	63.7 scores on a scale STANDARD_DEVIATION 14.3 • n=5 Participants
Eating behaviors by Three Factor Questionnaire Baseline uncontrolled eating	41.8 scores on a scale STANDARD_DEVIATION 17.9 • n=5 Participants	42.7 scores on a scale STANDARD_DEVIATION 17.9 • n=7 Participants	42.2 scores on a scale STANDARD_DEVIATION 17.9 • n=5 Participants
Eating behaviors by Three Factor Questionnaire Baseline emotional eating	51.4 scores on a scale STANDARD_DEVIATION 25.4 • n=5 Participants	53.9 scores on a scale STANDARD_DEVIATION 24.5 • n=7 Participants	52.6 scores on a scale STANDARD_DEVIATION 24.9 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

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 months

Among 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

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

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

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

Catherine Reale

UPenn

Phone: 215-746-4009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place