Using Technology to Share Fitness Goals and Results to Improve Diabetes Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Reduction in hemoglobin a1c
研究概览
简要总结
The investigators will recruit DoD beneficiaries, aged 18 years or older and diagnosed as being Type II diabetic. Patients will be randomized into one of two groups. Group 1 will use a fitness tracker but will not be able to see other participants data and group 2 will use a fitness tracker and will be able to see other members daily and weekly results. Outcome measures will be assessed at baseline, 3 months and 6 months to include hemoglobin A1c, weight, body mass index, blood pressure, and number of hours and days fitness tracker is used. The goal is to see if the group randomized into an online community will have improved activity and outcome measurements compared with those who use the pedometer alone.
详细描述
Male and female DoD beneficiaries ages 18 years or older who have been diagnosed with Type II diabetes, will be recruited at the Mike O'Callaghan Federal Medical Center (MOFMC).
Screening Visit:
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Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
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Record: Date of birth, phone number, age, gender, race, ethnicity, social security number, current email address, height (in inches), weight (in pounds), blood pressure, medications list including any over-the-counter and prescription weight loss medication (name, strength, dose) or supplements.
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Subjects will have the following standard of care blood test drawn which include:
-
Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)
Visit 1 (Day 1 within 1 week of Screening Visit):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •YOU MUST BE ABLE TO GET CARE AT NELLIS AFB (A MILITARY INSTALLATION) IN ORDER TO PARTICIPATE IN THIS STUDY.
- •Male and female DoD beneficiaries, age 18 years or older, who have been diagnosed with Type II Diabetes
- •Ability to set up fitness tracking software on personal computer or cell phone
- •Ability to learn and use personal activity monitor
排除标准
- •Male and female DoD beneficiaries, under the age of 18 years
- •Unwilling to share personal fitness results anonymously
- •Inability to do 4 metabolic equivalents of exercise (walk 100feet, walk up flight of stairs etc).
- •Inability to walk without the use of assistive devices (cane is OK)
- •Medical problem which would make walking unsafe (recent surgery, uncontrolled heart condition, fall risk etc).
- •No special populations (e.g., pregnant women, children, prisoners, detainees) will be recruited.
研究组 & 干预措施
Fitness Tracker
will use a fitness tracker but will not be able to see other participant's data
干预措施: Fitness Tracker (Behavioral)
Fitness Tracker with Group Participation
will use a fitness tracker and will be able to see other member's daily and weekly results
干预措施: Behavioral: Fitness Tracker (Behavioral)
结局指标
主要结局
Reduction in hemoglobin a1c
时间窗: 6 months
次要结局
未报告次要终点