- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01246687
Web-based Dietary Intervention for Diabetic Patients (myDIDeA)
Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach
The Internet holds promise for a wide-scale promotion of dietary and lifestyle behavioural change. Website-delivered interventions have a potentially broad population reach as it is available 24 hours, and could be hosted by both government and non-governmental agencies. To date, there is no published study focused on dietary behaviour change in adults with Type 2 Diabetes Mellitus (T2DM) via a website-based system.
myDIDeA was a 12-months two-armed randomised controlled trial conducted in three tertiary public hospitals in Klang Valley, Malaysia. The primary outcome was the Dietary Knowledge, Attitude and Behaviour (DKAB) score, while the secondary outcomes included the food intake, anthropometry measurements, blood pressure and resting heart rate, blood biomarkers and the Dietary Stages of Change (DSOC) score.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Selangor
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Batu Caves, Selangor, 말레이시아, 68100
- Hospital Selayang
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Kajang, Selangor, 말레이시아, 43000
- Hospital Serdang
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Wilayah Persekutuan Putrajaya
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Putrajaya, Wilayah Persekutuan Putrajaya, 말레이시아, 62250
- Hospital Putrajaya
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Mentally sound men and women who are > 18 years old.
- Literate with a fair command of English and/or Malay languages.
- Have access to the Internet at home, work or public place.
- Willing to access the web portal at least once every fortnight.
- Have been confirmed to have HbA1c of >7%.
- KAB score < 50% at baseline.
Exclusion Criteria:
- Pregnant, lactating or intend to become pregnant during the study period.
- Diagnosed with Type 1 Diabetes Mellitus (T1DM) or Gestational Diabetes Mellitus (GDM)
- Weighing not more than 150% of the desired weight for height.
- Any pre-existing condition compromising the quality of life or ability to participate according to protocol.
- Have severe complications (chronic heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, chronic liver or kidney disease) that would affect the subjects' ability to follow the tailored advice.
- Enrolled in other clinical studies.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: e-Intervention group
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
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Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
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간섭 없음: Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change from Baseline in Dietary KAB Score at 6 months
기간: Baseline & 6 months
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Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
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Baseline & 6 months
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Change from Baseline in Dietary KAB Score at 12 months
기간: Baseline & 12 months
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Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
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Baseline & 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change from Baseline in anthropometric measurements at 6 months
기간: Baseline & 6 months
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BMI, body fat percentage, waist circumference
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Baseline & 6 months
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Change from Baseline in anthropometric measurements at 12 months
기간: Baseline & 12 months
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BMI, body fat percentage, waist circumference
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Baseline & 12 months
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Change from Baseline in dietary practices at 6 months
기간: Baseline & 6 months
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Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
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Baseline & 6 months
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Change from Baseline in dietary practices at 12 months
기간: Baseline & 12 months
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Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
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Baseline & 12 months
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Change from Baseline in blood biomarkers at 6 months
기간: Baseline & 6 months
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HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
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Baseline & 6 months
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Change from Baseline in blood biomarkers at 12 months
기간: Baseline & 12 months
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HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
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Baseline & 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kia Fatt Quek, PhD, Monash University (Sunway Campus)
간행물 및 유용한 링크
일반 간행물
- Ramadas A, Chan CKY, Oldenburg B, Hussein Z, Quek KF. Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes: changes in health cognitions and glycemic control. BMC Public Health. 2018 Jun 8;18(1):716. doi: 10.1186/s12889-018-5640-1.
- Ramadas A, Quek KF, Chan CK, Oldenburg B, Hussein Z. Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA. BMC Public Health. 2011 May 21;11:359. doi: 10.1186/1471-2458-11-359.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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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