Incentivizing Lifestyle Modification to Reduce Disease Burden

Intervention Group:

After successfully passing the screening criteria, name, address, contact information, body
weight (in light outdoor clothes and without shoes), height (without shoes), body fat
percentage, BMI, waist circumference, age, and sex will be noted. Only the questions about
medical history that are pertinent to determining the eligibility (as described above), will
be asked. There will be a two week lead-in time period during which grocery store receipts
will be collected and the participants will wear a Fitbit Flex pedometer at all times. This
is to track food purchasing and consumption patterns and a method of determining a baseline
activity level, respectively. The participants will meet with the researcher at the
beginning of this two week period in order to give the participants the Fitbit Flexes. These
receipts will be collected at the end of the two week time period.

After this lead-in, the participants will begin their four week testing period. Body weight
and body fat will be determined on day 0 by using a bioimpedance measurement scale. This is
a scale like the bathroom scale on which a person stands and holds onto two handles
connected to the base by cables, while the machine reads body weight and body fat content
(by passing a mild electric current through the body, similar to an electrocardiogram). Body
weight and fat content will be determined once per week, for 4 weeks. The last body weight
and body fat measurements will be at the end of the 4 week walking period. The four week
testing period will include meeting at an agreed upon community center location and time
convenient for both the participant and the researcher. During these meetings, the
participants will engage in indoor walking under the supervision of the researcher. This is
to ensure accurate walking distance recording and also to monitor the participants for any
potential adverse events. The participants will have the option of walking as long or short
as they please, so long that it is less than 20 miles per week. This is to protect the
participants from exhaustion or overexertion. This process will continue for four weeks. At
the end of each week, grocery store receipts will be collected to reflect food purchasing
and consumption. The Fitbit Flex will remain worn by the participants at all times in order
to track activity changes, outside of the supervised walking. At the end of this four week
testing period, the total number of miles will be calculated (maximum of 80 miles). For
every mile walked, the participants will earn dollar points. The money earned by each
participant will be split between their utility payments and healthy food at a local grocery
store. The research team will provide a list of healthful foods to the participants. It will
include healthful foods such as fruits (and 100% juices), vegetables (and 100% juices),
non-fat or low fat dairy products, low-fat whole grain products (bread, bagels, breakfast
cereals, muffins), and uncooked fish and chicken.

During week 1, nutrition information will be provided. This will consist of brief nutrition
information sessions and a grocery store tour to assist with selection of foods available
with program coupons. The tour will be aimed at helping the subjects identify healthier food
choices and to suggest alternatives and options to high-fat and/or low nutrient-dense foods.

After this four week testing period, there will be a secondary four week follow-up period.
This will be the same as the four week testing period, minus the supervised walking and
earning of money based on miles walked. This follow-up period is purposed to record food
purchasing and consumption patterns along with everyday activity after their intervention.
The participants will remain wearing their Fitbit Flexes and turning in their grocery store
receipts.

Control Group:

The control group will have the same two week lead-in period in order to get a baseline food
and activity level.

During the four week testing period for the control group, the participants will be
encouraged to participate in supervised walking. However, the participants will not be
earning money based on miles walked. The number of miles will be recorded, but strictly to
be compared against the testing period of the intervention group.

The four week follow-up time period will be the same as the intervention group, with one
exception. The control group will have the option to walk under supervision during their
follow-up period in order to earn money under the same set of rules as the intervention
group during their testing period. This opportunity to earn money is an effort to encourage
participation and keep participants in the control group interested. The participants of the
control group during the follow-up period will; however, continue to wear their Fitbit
Flexes at all times and grocery store receipts will be collected.

Additional Procedural Information Throughout the study for both groups, the participants
will be paid a small amount for their participation in the study. The payment will be
identical for both the control and intervention groups. This is just a payment for the
participants' time invested in the study. However, the participants will not receive their
weekly participation money unless they turn in their receipts. This is to encourage the
turning in of receipts for our study records.

In the prior arrangement with designated grocery stores, foods that could be purchased with
the coupons or gift cards will be predetermined. The value, types of food, quantity
purchased, and the user name will be recorded for further analysis.

At the end of the four week follow-up period for both groups, there will be an exit
interview for all participants of the study. This interview will ask simple questions such
as what the participants liked the most about the study, what they liked least, what we
could improve upon, how they prefer to receive their earned money, and what most motivated
them to walk. This interview will be one-on-one with the researcher and results will be kept
confidential.

Text message reminders will be given in order to remind the participants of any upcoming
appointments related to the study.

At the conclusion of the study for both groups, the participants will turn in their Fitbit
Flexes to the researcher. The conclusion of this study for both groups will be the ten week
mark, starting with the first day of the lead-in period and concluded at the end of the
follow-up period.

Inclusion Criteria:

1. Sedentary (< 3 hours/week of moderate intensity physical activity), and otherwise
healthy men and women

2. Willingness to: follow the instructions, and to attend regularly,

3. BMI 25 - 50 kg/M2

4. Age: 18y - 65 y. Subjects will be screened prior to the study.

Exclusion Criteria:

1. Significant cardiac disease in the past 6 months (Myocardial Infarction, angioplasty,
Congestive Heart Failure, Left Bundle Branch Block, 3rd degree AV- block, CABG),

2. Uncontrolled hypertension (systolic BP > 180 or diastolic BP > 105 mm Hg),

3. Medications that could interfere with outcomes and that could not be safely withdrawn
prior to testing,

4. Pregnancy or intention to conceive during the study period,

5. Current substance abuse,

6. Indications of potential difficulties adhering to the protocol,

7. Subjects who in the opinion of the investigators are inappropriate for study
participation or who would be at additional risk by participating,

8. Physical or medical limitation for exercise, intermittent claudication, severe back
pain or spasm, inability to ambulate independently or without the use of a cane or
walker,

9. Unexcused absence for more than 2 continuous weeks, irregular attendance,
non-cooperation, conception, or change in the health status that would jeopardize the
subject could be grounds for expulsion from the study.