Incentivizing Lifestyle Modification to Reduce Disease Burden
Condition: Obesity; Diabetes Mellitus
Study type: Interventional

Summary: 
      Specifically, the main objective of this pilot and feasibility study is to develop the
      infrastructure that will be used in a larger study that would be proposed at a later date.
      Hence, this study has two parts. Part A: To establish contacts, collaboration, and networking
      to develop the infrastructure needed to conduct the study, Part B: To recruit eight subjects
      (4 subjects randomly assigned to either a control group or intervention group) from a
      low-income community in East Lubbock who are willing and able to participate in this pilot
      study. The research team's central hypothesis is that the disease burden of obesity and
      related co-morbidities could be attenuated within low-income communities by providing
      incentive-based free access to a safe and convenient exercise facility and earned credit to
      subsidize healthful food cost. The research team's secondary hypothesis is that the
      anticipated decrease in disease burden will make the incentivized changes in lifestyle
      cost-effective.
    

Detailed description: 
      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.
    

Intervention name(s): Required supervised walking; Non-required supervised walking; Fitbit Flex
Intervention type(s): Behavioral; Behavioral; Device
Intervention description(s): The intervention 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. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study.; The intervention 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. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; activity; behavior