At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Incentivizing Lifestyle Modification to Reduce Disease Burden.
In Brief
A clinical study evaluating Required supervised walking, Non-required supervised walking, and 1 other intervention for Obesity and Diabetes Mellitus. Completed, enrolled 8 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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 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.