ObesityNCT02945332
Incentivizing Lifestyle Modification to Reduce Disease Burden
A study testing Required supervised walking, Non-required supervised walking and Fitbit Flex in people with Obesity and Diabetes Mellitus, run by Texas Tech University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus
- What is being tested?
- Required supervised walking, Non-required supervised walking and Fitbit Flex
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary (< 3 hours/week of moderate intensity physical activity), and otherwise healthy men and women
- Willingness to: follow the instructions, and to attend regularly,
- BMI 25 - 50 kg/M2
- Age: 18y - 65 y. Subjects will be screened prior to the study.
Who cannot join
- Significant cardiac disease in the past 6 months (Myocardial Infarction, angioplasty, Congestive Heart Failure, Left Bundle Branch Block, 3rd degree AV- block, CABG),
- Uncontrolled hypertension (systolic BP > 180 or diastolic BP > 105 mm Hg),
- Medications that could interfere with outcomes and that could not be safely withdrawn prior to testing,
- Pregnancy or intention to conceive during the study period,
- Current substance abuse,
- Indications of potential difficulties adhering to the protocol,
Show all 9Show fewer
- Subjects who in the opinion of the investigators are inappropriate for study participation or who would be at additional risk by participating,
- 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,
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incentivizing Lifestyle Modification to Reduce Disease Burden.
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.
Read the 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.
- Conditions
- Obesity, Diabetes Mellitus
- Being tested
- Required supervised walking, Non-required supervised walking, Fitbit Flex
- Keywords
- exercise, activity, behavior
- Medical subject headings
- Obesity, Diabetes Mellitus, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Required supervised walkingBehavioural
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.
Non-required supervised walkingBehavioural
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 not necessarily under the supervision of the researcher. Accurate walking distance recording will be done and also 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.
Fitbit FlexDevice
| Study group | Role | What they receive |
|---|---|---|
| Required supervised walking | Experimental | Device: Fitbit Flexes Receives: Behavioral: Required supervised walking; Device: Fitbit Flex |
| Non-required supervised walking | Active comparator | Device: Fitbit Flexes Receives: Behavioral: Non-required supervised walking; Device: Fitbit Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miles Walked
This study will determine the miles walked in presence and absence of financial incentive
Measured: Conclusion of data recording; approximately 10 weeks after the participant begins the study.
Secondary outcomes (5)
Weight Change
Weight will be recorded on an Omron portable bioimpedance scale.
Measured: From day 0 through week 6 of the study.
Body Fat Percentage Change
Body fat percentage will be recorded with the Omron portable bioimpedance scale.
Measured: From day 0 through week 6 of the study.
Fat Mass Change
Fat mass change will be recorded by the portable Omron bioimpedance scale.
Measured: From day 0 through week 6 of the study.
Fat Free Mass Change
Fat free mass will be recorded with the Omron portable bio-impedance scale.
Measured: From day 0 through week 6 of the study.
Waist Circumference Change
Waist circumference will be recorded with a body circumference tape.
Measured: From day 0 through week 6 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- RGK Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945332
- Sponsor's protocol ID
- 109495
- Status last verified
- Nov 2025
- First submitted
- 31 Aug 2016
- Last updated
- 24 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentivizing Lifestyle Modification to Reduce Disease Burden.
- ClinicalTrials.gov ID
- NCT02945332
- Acronym / sponsor ID
- 109495
- Conditions
- Obesity, Diabetes Mellitus
- Keywords
- exercise, activity, behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- RGK Foundation
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Required supervised walking | Experimental | Behavioral: Required supervised walking, Device: Fitbit FlexDevice: Fitbit Flexes |
| Non-required supervised walking | Active comparator | Behavioral: Non-required supervised walking, Device: Fitbit FlexDevice: Fitbit Flexes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sedentary (< 3 hours/week of moderate intensity physical activity), and otherwise healthy men and women
- Willingness to: follow the instructions, and to attend regularly,
- BMI 25 - 50 kg/M2
- Age: 18y - 65 y. Subjects will be screened prior to the study.
Key exclusion criteria (9 listed)
- Significant cardiac disease in the past 6 months (Myocardial Infarction, angioplasty, Congestive Heart Failure, Left Bundle Branch Block, 3rd degree AV- block, CABG),
- Uncontrolled hypertension (systolic BP > 180 or diastolic BP > 105 mm Hg),
- Medications that could interfere with outcomes and that could not be safely withdrawn prior to testing,
- Pregnancy or intention to conceive during the study period,
- Current substance abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Required supervised walkingThe 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. | Behavioural | Required supervised walking |
| Non-required supervised walkingThe 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 not necessarily under the supervision of the researcher. Accurate walking distance recording will be done and also 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. | Behavioural | Non-required supervised walking |
| Fitbit Flex | Device | Non-required supervised walking, Required supervised walking |
Primary outcome
Miles Walked
Time frame: Conclusion of data recording; approximately 10 weeks after the participant begins the study.
This study will determine the miles walked in presence and absence of financial incentive
5 secondary outcomes
Weight Change
Time frame: From day 0 through week 6 of the study.
Body Fat Percentage Change
Time frame: From day 0 through week 6 of the study.
Fat Mass Change
Time frame: From day 0 through week 6 of the study.
Fat Free Mass Change
Time frame: From day 0 through week 6 of the study.
Waist Circumference Change
Time frame: From day 0 through week 6 of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Required supervised walking, Non-required supervised walking and Fitbit Flex in people with Obesity and Diabetes Mellitus, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miles Walked (time frame: Conclusion of data recording; approximately 10 weeks after the participant begins the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.