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临床试验/NCT02945332
NCT02945332已完成不适用

Incentivizing Lifestyle Modification to Reduce Disease Burden.

Texas Tech University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Miles Walked

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Miles Walked

时间窗: 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

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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