N/A
Completed N=8
Incentivizing Lifestyle Modification to Reduce Disease Burden
Source: ClinicalTrials.gov NCT02945332 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Miles Walked — 1.1; 6.06 Miles — p=0.32
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Miles Walked |
1.1; 6.06 | 0.32 |
| SECONDARY Weight Change |
2.6; 0.8 | 0.93 |
| SECONDARY Body Fat Percentage Change |
1.3; 3.5 | 0.16 |
| SECONDARY Fat Mass Change |
4.8; 0.15 | 0.40 |
| SECONDARY Fat Free Mass Change |
-2.15; 2.8 | 0.77 |
| SECONDARY Waist Circumference Change |
0.8; 0.7 | 0.42 |
Eligibility Criteria
Inclusion Criteria
- Sedentary ( 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- Medications that could interfere with outcomes and that could not be safely withdrawn prior to testing,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,
- 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.
Data sourced from ClinicalTrials.gov (NCT02945332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.