Obesity
Conditions
Brief summary
This study aims to evaluate the effectiveness of financial incentives in improving and maintaining weight loss.
Detailed description
The study will evaluate the effectiveness of financial incentives in improving maintenance of weight loss. The investigators propose a 2-arm randomized controlled trial in which 258 participants who lose at least 5 kgs in a weight loss program will be randomized to one of the following: 1) daily weigh-ins and weekly feedback, 2) daily weigh-ins,weekly feedback, and a weekly escalating lottery-based financial incentive. Study participants will be obese volunteers recruited from a major community-based weight loss program (Weight Watchers), who have lost at least 5kg during the 4-6 months prior to enrolling in the study. Upon enrollment, these participants will have an active online membership with Weight Watchers. Among these participants, the following will be assessed: 1. Assess the effectiveness of escalating lottery rewards, relative to the control group, on maintenance of weight loss over the ensuing 6 months (Phase I); 2.The degree to which weight loss is maintained in the intervention group relative to usual care during the 6 months following the cessation of the interventions (Phase II). During Phase I, incentives will be provided to some study participants (escalating lottery arm) for the first 6 months and participants will be followed for 6 more months to examine effects following cessation of incentives.
Interventions
BEHAVIORALEscalating Lottery
Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
Sponsors
Duke University
National Institute on Aging (NIA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults age 30-80 * BMI between 30 and 45 prior to starting Weight Watchers * Have a documented weight loss of at least 5kg in the past 4-6 months before enrolling * Stable health * Have an online Weight Watchers membership
Exclusion criteria
* Substance abuse * Bulimia nervosa or related behaviors * Pregnancy or breast feeding * Medical contraindications to counseling about diet, physical activity, or weight reduction * Unstable mental illness * Screen positive for pathological gambling on the basis of the 10 item DSM-IV criteria (excluded if meets 5 or more criteria) * Individuals unable to read consent forms or fill out surveys in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight, Baseline and 6 Months | 6 months | 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 |
| Change in Weight, 6 Months and 12 Months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 130 |
| 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. | 128 |
| Total | 258 |
Baseline characteristics
| Characteristic | Total | Control | Escalating Lottery |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 8 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 246 Participants | 122 Participants | 124 Participants |
| Age, Continuous | 48 Years STANDARD_DEVIATION 10.5 | 49.2 Years STANDARD_DEVIATION 10.6 | 46.9 Years STANDARD_DEVIATION 10.2 |
| Baseline IPAQ Level High | 102 Participants | 58 Participants | 44 Participants |
| Baseline IPAQ Level Low | 48 Participants | 20 Participants | 28 Participants |
| Baseline IPAQ Level Missing | 1 Participants | 0 Participants | 1 Participants |
| Baseline IPAQ Level Moderate | 107 Participants | 52 Participants | 55 Participants |
| Baseline MVPA minutes/week | 150 Minutes per week | 180 Minutes per week | 145 Minutes per week |
| Baseline Walking minutes/week | 210 Minutes per week | 210 Minutes per week | 210 Minutes per week |
| BMI at randomization | 32.1 kg/m^2 STANDARD_DEVIATION 3.9 | 31.7 kg/m^2 STANDARD_DEVIATION 3.7 | 32.6 kg/m^2 STANDARD_DEVIATION 4.2 |
| Eating behaviors by Three Factor Questionnaire Baseline cognitive restraint | 63.7 scores on a scale STANDARD_DEVIATION 14.3 | 63.2 scores on a scale STANDARD_DEVIATION 12.9 | 64.1 scores on a scale STANDARD_DEVIATION 15.6 |
| Eating behaviors by Three Factor Questionnaire Baseline emotional eating | 52.6 scores on a scale STANDARD_DEVIATION 24.9 | 51.4 scores on a scale STANDARD_DEVIATION 25.4 | 53.9 scores on a scale STANDARD_DEVIATION 24.5 |
| Eating behaviors by Three Factor Questionnaire Baseline uncontrolled eating | 42.2 scores on a scale STANDARD_DEVIATION 17.9 | 41.8 scores on a scale STANDARD_DEVIATION 17.9 | 42.7 scores on a scale STANDARD_DEVIATION 17.9 |
| Education College degree | 74 Participants | 33 Participants | 41 Participants |
| Education High School or less | 33 Participants | 22 Participants | 11 Participants |
| Education Post graduate | 75 Participants | 33 Participants | 42 Participants |
| Education Some college | 76 Participants | 42 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 243 Participants | 121 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Household Size | 3 people per household STANDARD_DEVIATION 1.4 | 2.8 people per household STANDARD_DEVIATION 1.3 | 3.2 people per household STANDARD_DEVIATION 1.6 |
| Income $100,000 to $149,000 | 76 Participants | 41 Participants | 35 Participants |
| Income >=$150,000 | 26 Participants | 12 Participants | 14 Participants |
| Income <$50,000 | 29 Participants | 15 Participants | 14 Participants |
| Income $50,000 to $99,000 | 127 Participants | 62 Participants | 65 Participants |
| Postpone things even though it would be better to get done right away Least averse to risks | 34 Participants | 16 Participants | 18 Participants |
| Postpone things even though it would be better to get done right away Moderate averse to risks | 135 Participants | 70 Participants | 65 Participants |
| Postpone things even though it would be better to get done right away Most averse to risks | 89 Participants | 44 Participants | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 235 Participants | 120 Participants | 115 Participants |
| Sex: Female, Male Female | 225 Participants | 113 Participants | 112 Participants |
| Sex: Female, Male Male | 33 Participants | 17 Participants | 16 Participants |
| Weight loss prior to randomization | 11.6 kilograms STANDARD_DEVIATION 4.2 | 11.5 kilograms STANDARD_DEVIATION 4.3 | 11.8 kilograms STANDARD_DEVIATION 4.1 |
| Willing to give up something today in order to benefit in the future Least averse to risks | 34 Participants | 16 Participants | 18 Participants |
| Willing to give up something today in order to benefit in the future Moderate averse to risks | 135 Participants | 70 Participants | 65 Participants |
| Willing to give up something today in order to benefit in the future Most averse to risks | 89 Participants | 44 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 130 | 0 / 128 |
| other Total, other adverse events | 4 / 130 | 2 / 129 |
| serious Total, serious adverse events | 5 / 130 | 3 / 129 |
Outcome results
Primary
Change in Weight, 6 Months and 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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Weight, 6 Months and 12 Months | -0.6 Kilograms | Standard Deviation 8.2 |
| Escalating Lottery | Change in Weight, 6 Months and 12 Months | 0.2 Kilograms | Standard Deviation 8.1 |
Primary
Change in Weight, Baseline and 6 Months
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Weight, Baseline and 6 Months | -1.9 Kilograms | Standard Deviation 5.9 |
| Escalating Lottery | Change in Weight, Baseline and 6 Months | -1.1 Kilograms | Standard Deviation 5.7 |