Web-based Dietary Intervention for Diabetic Patients (myDIDeA)
2017年12月24日 更新者：Amutha Ramadas、Monash University
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.
調査の概要
詳細な説明
The study was designed according to the recommendations of the CONSORT statement for randomised trials of non-pharmacologic treatment.
The study commenced in November 2009 after obtaining the ethical approvals from relevant authorities, and the trial has been registered with Clinicaltrials.gov
(NCT01246687).
After being screened for eligibility, 128 patients with Type 2 Diabetes Mellitus (T2DM) from the outpatient clinics at these hospitals were recruited into the study with informed consent.
After the baseline data collection, the participants were randomised into the e-intervention (n=66) or the control (n=62) group.
The e-intervention group received an intensive six-month dietary intervention through the study website, which was developed based on various established guidelines and recommendations but personalised according to the participants' DSOC, in addition to the usual standard treatment at the outpatient clinics.
In contrast, the control group received the usual standard treatment given to patients with T2DM, and did not receive the website login information, or any reinforcement via e-mail or SMS.
Data were collected at baseline, six months post-intervention and at 12 months follow-up.
A structured and pre-tested questionnaire was used for this purpose.
The anthropometry measurements, blood pressure and resting heart rate were measured at data collection.
Details on the blood biomarkers were obtained from the hospital medical records.
The statistical analysis revealed that myDIDeA was successful in improving overall DKAB score by improving the diabetes-related dietary knowledge and attitude of the participants.
Besides, the intervention programme also have successfully improved the DSOC score of the intervention group, suggesting the participants were indeed making small but significant progress in changing their dietary behaviour.
Improvement in the diet quality (improvement in vegetable intake and reduction in carbohydrate and protein intake), glycaemic control and total cholesterol have added credibility to this web-delivered intervention.
The process evaluation of the study website revealed that on the average each participant logged in the website once a week and spent 11 minutes at the website per visit.
The usability (facilitating conditions) scored the highest, while the acceptability (anxiety) scored the lowest.
研究の種類
介入
入学 (実際)
134
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Selangor
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Batu Caves、Selangor、マレーシア、68100
- Hospital Selayang
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Kajang、Selangor、マレーシア、43000
- Hospital Serdang
-
-
Wilayah Persekutuan Putrajaya
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Putrajaya、Wilayah Persekutuan Putrajaya、マレーシア、62250
- Hospital Putrajaya
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：e-Intervention group
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
|
Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
|
|
介入なし：Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Dietary KAB Score at 6 months
時間枠：Baseline & 6 months
|
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
|
Baseline & 6 months
|
|
Change from Baseline in Dietary KAB Score at 12 months
時間枠：Baseline & 12 months
|
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
|
Baseline & 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in anthropometric measurements at 6 months
時間枠：Baseline & 6 months
|
BMI, body fat percentage, waist circumference
|
Baseline & 6 months
|
|
Change from Baseline in anthropometric measurements at 12 months
時間枠：Baseline & 12 months
|
BMI, body fat percentage, waist circumference
|
Baseline & 12 months
|
|
Change from Baseline in dietary practices at 6 months
時間枠：Baseline & 6 months
|
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
|
Baseline & 6 months
|
|
Change from Baseline in dietary practices at 12 months
時間枠：Baseline & 12 months
|
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
|
Baseline & 12 months
|
|
Change from Baseline in blood biomarkers at 6 months
時間枠：Baseline & 6 months
|
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
|
Baseline & 6 months
|
|
Change from Baseline in blood biomarkers at 12 months
時間枠：Baseline & 12 months
|
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
|
Baseline & 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Kia Fatt Quek, PhD、Monash University (Sunway Campus)
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2010年3月1日
一次修了 (実際)
2011年6月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2010年11月22日
QC基準を満たした最初の提出物
2010年11月22日
最初の投稿 (見積もり)
2010年11月23日
学習記録の更新
投稿された最後の更新 (実際)
2017年12月27日
QC基準を満たした最後の更新が送信されました
2017年12月24日
最終確認日
2017年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。