Incentivizing Lifestyle Modification to Reduce Disease Burden

NCT02945332 | Completed Results

• 1 other identifier: 109495
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus

Keywords

exercise; activity; behavior

Outcome Measures

Primary Outcomes (1)

• Miles Walked

  This study will determine the miles walked in presence and absence of financial incentive

  Conclusion of data recording; approximately 10 weeks after the participant begins the study.

Secondary Outcomes (5)

• Weight Change

  From day 0 through week 6 of the study.

• Body Fat Percentage Change

  From day 0 through week 6 of the study.

• Fat Mass Change

  From day 0 through week 6 of the study.

• Fat Free Mass Change

  From day 0 through week 6 of the study.

• Waist Circumference Change

  From day 0 through week 6 of the study.

Other Outcomes (1)

• Food Purchasing Change

  Day 0-6 weeks

Study Arms (2)

Required supervised walking

EXPERIMENTAL

Device: Fitbit Flexes

Behavioral: Required supervised walking; Device: Fitbit Flex

Non-required supervised walking

ACTIVE COMPARATOR

Device: Fitbit Flexes

Behavioral: Non-required supervised walking; Device: Fitbit Flex

Interventions

Required supervised walking BEHAVIORAL

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.

Required supervised walking

Non-required supervised walking BEHAVIORAL

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.

Non-required supervised walking

Fitbit Flex DEVICE

Non-required supervised walking; Required supervised walking

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Texas Tech University: lead
• RGK Foundation: collaborator

Study Sites (1)

Lubbock Dream Center

Lubbock, Texas, 79411, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Nikhil Dhurandhar
• Organization: Texas Tech University

nikhil.dhurandhar@ttu.edu

806 834-6446

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: October 26, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

Locations

US (1)