Incentivizing Lifestyle Modification to Reduce Disease Burden

Completed · Not applicable

Conditions studied: Obesity, Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02945332

Run by

Texas Tech University

People needed

8

Starts

2016-10-01

Expected to finish

2016-12-01

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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• Medications that could interfere with outcomes and that could not be safely withdrawn prior to testing,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,
• 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.

Where it is running

• Lubbock Dream Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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