Clinical trial NCT02945332: Incentivizing Lifestyle Modification to Reduce Disease Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes Mellitus
Keywords: exercise
activity
behavior
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: RGK Foundation
First posted: 2016-10-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Miles walked
timeFrame: Conclusion of data recording; approximately 10 weeks after the participant begins the study.
Secondary outcomes:
measure: Height
timeFrame: From day 0 through week 6 of the study.
measure: Weight change
timeFrame: From day 0 through week 6 of the study.
measure: Body fat percentage change
timeFrame: From day 0 through week 6 of the study.
measure: Body mass index change
timeFrame: From day 0 through week 6 of the study.
measure: Fat mass change
timeFrame: From day 0 through week 6 of the study.
measure: Fat free mass
timeFrame: From day 0 through week 6 of the study.
measure: Waist circumference change
timeFrame: From day 0 through week 6 of the study.
Other outcomes:
measure: Food purchasing change
timeFrame: Two weeks into the study, then weekly throughout the study, concluding at the 10 week mark of the study.
measure: Food consumption change
timeFrame: Two weeks into the study, then weekly throughout the study, concluding at the 10 week mark of the study.
Locations:
city: Lubbock
country: United States
facility: Lubbock Dream Center
state: Texas
Study officials:
References: