- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03709966
Portable Monitoring Device, Physical Activity Motivation and Patients With Type 2 Diabetes (DBFitbit)
2020년 10월 14일 업데이트: Caroline, Laval University
Using a Portable Monitoring Device to Increase Motivation for Physical Activity in Patients With Type 2 Diabetes
The intervention proposed for this project aims to improve the practice of physical activity (PA) for people with type 2 diabetes by increasing their motivation using a portable device to monitor PA (FitBit).
This study will provide preliminary data to assess the feasibility of the intervention, its acceptability for patients with type 2 diabetes, and its potential impact of PA motivation and PA level.
연구 개요
상세 설명
It is recognized that the adoption of healthy lifestyle habits, such as the practice of physical activity (PA) on a regular and constant basis, contributes significantly to reducing the prevalence of diabetes and its complications.
The use of portable technological support to monitor PA can contribute to a favorable behavioral change in people with chronic diseases such as diabetes.
Objective: The intervention proposed for this project aims to improve the practice of PA for people with type 2 diabetes, by increasing their motivation using a portable device tracking of PA (FitBit).
The device is similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status.
The information recorded by the watch can be synchronized and transmitted directly to the FitBit application, allowing it to be viewed and tracked on a daily basis, and also the ability to produce weekly and monthly reports and adjust personal goals.
Methods: This study consists in a pilot randomized controlled trial of 30 Type 2 diabetes patients already followed by health professionals from a University-affiliated Family Medicine Group (GMF-U Quatre-Bourgeois).
Patients are randomly assigned to one of these two conditions: routine follow-up, including a PA promotion intervention supported by a kinesiologist from the research center of the Institut de cardiologie et de pneumologie de Québec (CRIUCPQ) or FitBit follow-up, which consists of routine follow-up with the adding the portable PA tracking device.
We plan to recruit 15 patients per group.
The randomization is done by a statistician from CRIUCPQ.
Inclusion and Exclusion Criteria: To participate in the study, participants must meet the following inclusion criteria: to be in a stable medical condition, sedentary and type 2 diabetic man or woman between the ages of 18 and 90 years of age.
People with acute renal failure, FG below 30 ml and those under 18 years of age are excluded.
Intervention: The intervention lasts 3 months and involves a total of 3 appointments.
The first appointment takes place with the physician in charge of the study in order to evaluate the patient's record and to validate their eligibility.
The glycated hemoglobin data and cardiometabolic measurements taken by the attending physician of each participant will be collected by the physician and clinical researcher in charge of the project.
These same measures will be taken at the 3-month follow-up prescribed to each participant and this data will be collected a second and last time by the physician in charge of the project, at the very end of the intervention.
Following their visit to the physician in charge of the study, the participants will meet the research professional who will be responsible for explaining the project in more details and obtaining their consent.
The second appointment is attended by a kinesiologist who will distribute a physical activity motivation questionnaire, a physical activity questionnaire and a logbook to the participants.
A personalized physical activity program will also be proposed to all participants.
At the 6th week of the intervention, the kinesiologist will follow up with all participants to verify the integration of the physical activity program.
A third appointment is planned at the very end of the intervention with the kinesiologist.
Participants will be asked to complete the same questionnaires as for visit # 2 and submit their completed logbook.
The participants in the experimental group will have a satisfaction questionnaire / appreciation of the technology to be completed in addition to the other questionnaires.
They will also have to bring back their Fitbit material during this appointment.
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Québec, 캐나다, G1V0B7
- GMF-UMF Laval-Québec
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- To be in a stable medical condition, sedentary, type 2 diabetic man or woman between the ages of 18 and 90 years of age
Exclusion Criteria:
- People with acute renal failure FG below 30 ml and those under 18 years of age.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: FitBit
Portable technological support to monitor physical activity, similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status.
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similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status
다른 이름들:
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활성 비교기: Routine
Physical activity promotion supported by a kinesiologist
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Physical activity promotion supported by a kinesiologist
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Physical activity measurements
기간: 3 months
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Godin Leisure-Time Exercise Questionnaire
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Motivation and auto-regulation of physical activity
기간: 3 months
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Behavioral Regulation in Exercise Questionnaire (BREQ) version 2
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3 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Acceptability, satisfaction of the portable monitoring device and compliance
기간: 3 months
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Homade questionnaire with 10 questions
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3 months
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Cardiometabolic measurements: glycated hemoglobin
기간: Before and after the clinical intervention: 3 months
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Blood test
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Before and after the clinical intervention: 3 months
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Cardiometabolic measurements: systolic and diastolic blood pressure
기간: Before and after the clinical intervention: 3 months
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Taken with standard apparel
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Before and after the clinical intervention: 3 months
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Cardiometabolic measurements: Weight
기간: Before and after the clinical intervention: 3 months
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measured with a bioimpedance balance InBody
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Before and after the clinical intervention: 3 months
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Cardiometabolic measurements: fat percentage
기간: Before and after the clinical intervention: 3 months
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measured with a bioimpedance balance InBody
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Before and after the clinical intervention: 3 months
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Cardiometabolic measurement: Triglycerides
기간: Before and after the clinical intervention: 3 months
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Blood test
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Before and after the clinical intervention: 3 months
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Cardiometabolic measurement: High-density lipoprotein cholesterol (HDL)
기간: Before and after the clinical intervention: 3 months
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Blood test
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Before and after the clinical intervention: 3 months
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Cardiometabolic measurement: Low-density lipoprotein cholesterol (LDL)
기간: Before and after the clinical intervention: 3 months
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Blood test
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Before and after the clinical intervention: 3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Caroline Rhéaume, MD-PhD, Laval University
- 연구 책임자: Caroline Rhéaume, MD-PhD, Laval University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 12월 7일
기본 완료 (실제)
2019년 3월 31일
연구 완료 (실제)
2019년 3월 31일
연구 등록 날짜
최초 제출
2018년 10월 15일
QC 기준을 충족하는 최초 제출
2018년 10월 15일
처음 게시됨 (실제)
2018년 10월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 10월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 10월 14일
마지막으로 확인됨
2020년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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