Mobile Health to Enhance Exercise in Type 2 Diabetes (MOTIVATET2D)
2021年4月26日 更新者：Jonathan Little、University of British Columbia
Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial
Being physically active and exercising is important for the treatment of Type 2 diabetes as it helps control blood sugar and improve physical function.
Lots of people find it hard to be physically active and sticking with exercise is difficult for most people.
In this project we will investigate two strategies to support people with Type 2 diabetes to increase and then maintain a physically active lifestyle, which includes exercising regularly.
Participants in one group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular (virtual) contact with an exercise specialist.
Participants in the second group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App).
The fitness watch and mobile App will allow the exercise specialist to provide greater support and feedback throughout the programme.
調査の概要
状態
募集
研究の種類
介入
入学 (予想される)
120
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。
研究連絡先
- 名前：Ali McManus, PhD
- 電話番号：250-807-8192
- メール：ali.mcmanus@ubc.ca
研究連絡先のバックアップ
- 名前：Matthew S Cocks, PhD
- 電話番号：0151 904 6243
- メール：M.S.Cocks@ljmu.ac.uk
研究場所
-
-
British Columbia
-
Kelowna、British Columbia、カナダ、V1V1V7
- 募集
- University of British Columbia
-
コンタクト：
- Jonathan Low
-
-
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
40年～75年 (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:
- Diagnosed with T2D within the previous 5-24 months
- Male or Female
- Aged 40-75
- Treat diabetes with only Metformin or lifestyle modifications (diet and exercise)
- For those prescribed Metformin: have used a stable dose for 3-months or more
Exclusion Criteria:
- Aged under 40 or over 75
- Glycated hemoglobin level (HbA1c) more than 10% (>86mmol/mol)
- Blood pressure higher than 160/110 mmHg
- Treat diabetes with an antidiabetic drug other than Metformin (Sulfonylureas, Thiazolidinedione, dipeptidylpeptidase-4 inhibitors, sodium glucose co-transporter 2 inhibitors, glucagon-like peptide-1 receptor agonist, Acarbose, meglitinides)
- Prescription of Insulin
- Unstable angina (frequent chest pain)
- Myocardial infarction (heart attack) within the previous 3 months
- Transient ischemic attack (TIA) within the previous 6 months
- Heart failure ≥class 2
- Arrhythmia
- Inability to increase activity
- Pregnancy or planning to become pregnant
- Less than 6 months post childbirth or stopped breastfeeding less than 1 month ago
- Not owning a smartphone/ or having no data plan or access to WiFi
- currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week).
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：処理
- 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：mHealth Technology
Participants in this group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App).
|
A 6 month exercise and physical activity programme supported by an exercise specialist
A fitness watch that links to a mobile phone application (App) which enables the exercise specialist to provide greater support and feedback throughout the programme
他の名前：
|
|
アクティブコンパレータ：Exercise Counselling
Participants in this group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular contact with an exercise specialist.
|
A 6 month exercise and physical activity programme supported by an exercise specialist
|
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 |
|---|---|---|
|
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
時間枠：0-12 months
|
Information will be collected on: - The number of patients approached and reasons for not joining the study |
0-12 months
|
|
The number of these adults with newly diagnosed T2D who would be willing to take part in this trial
時間枠：0-12 months
|
Information will be collected on: - The number of patients who actually enroll |
0-12 months
|
|
The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial
時間枠：0-12 months
|
Information will be collected on: - Patient gender, age, and how patients are currently treating their T2D |
0-12 months
|
|
The number and percentage of participants retained at 12-months.
時間枠：0-12 months
|
Information will be collected on: - Number and percentage of patients attending at 12-month follow up and reasons for drop-out. |
0-12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence to exercise
時間枠：0 months, 0-6 months, 0-12 months
|
Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)
|
0 months, 0-6 months, 0-12 months
|
|
Change in glycaemic control
時間枠：0 months, 0-6 months, 0-12 months
|
Glycated hemoglobin (HbA1c), flash glucose monitoring
|
0 months, 0-6 months, 0-12 months
|
|
Change in body composition
時間枠：0 months, 0-6 months, 0-12 months
|
Height (meters) and weight (kilograms) will be aggregated to arrive at one reported BMI value (kg/m^2)
|
0 months, 0-6 months, 0-12 months
|
|
Change in weight
時間枠：0 months, 0-6 months, 0-12 months
|
Weight (kilograms)
|
0 months, 0-6 months, 0-12 months
|
|
Change in waist circumference
時間枠：0 months, 0-6 months, 0-12 months
|
Waist circumference (centimeters)
|
0 months, 0-6 months, 0-12 months
|
|
Change in blood pressure
時間枠：0 months, 0-6 months, 0-12 months
|
Blood pressure taken with a cuff
|
0 months, 0-6 months, 0-12 months
|
|
Change in blood lipids
時間枠：0 months, 0-6 months, 0-12 months
|
Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein
|
0 months, 0-6 months, 0-12 months
|
|
Diabetes related quality of life
時間枠：0 months, 0-6 months, 0-12 months
|
SF-12 Health Survey and Diabetes Treatment Satisfaction Questionnaire used to assess diabetes related quality of life
|
0 months, 0-6 months, 0-12 months
|
|
Behavioural regulation in exercise
時間枠：0 months, 0-6 months, 0-12 months
|
Assessed using the Behavioural Regulation in Exercise Questionnaire
|
0 months, 0-6 months, 0-12 months
|
|
Patient rapport with counsellor
時間枠：0 months, 0-6 months, 0-12 months
|
Assessed using the Patient Rapport with Counsellor Questionnaire
|
0 months, 0-6 months, 0-12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability and feasibility of the wearable intervention to patients
時間枠：0-6 months, 0-12 months
|
Post-intervention patient questionnaire that will assess the acceptability of the wearable intervention and exposure to other wearable technologies
|
0-6 months, 0-12 months
|
|
Acceptability and feasibility of patients continuing the intervention on their own
時間枠：0-6 months, 0-12 months
|
Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention
|
0-6 months, 0-12 months
|
|
Pilot methods for collecting outcome measures
時間枠：Approx. 1 month after baseline
|
Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use.
|
Approx. 1 month after baseline
|
|
Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients
時間枠：0-12 months
|
Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments
|
0-12 months
|
|
Determine availability and completeness of economic data
時間枠：0 months, 0-6 months, 0-12 months
|
5-level EQ-5D Questionnaire
|
0 months, 0-6 months, 0-12 months
|
|
Determine healthcare usage
時間枠：0 months, 0-6 months, 0-12 months
|
Questionnaire assessing healthcare usage in the last 12 weeks
|
0 months, 0-6 months, 0-12 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。
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。
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)
2021年2月1日
一次修了 (予想される)
2022年12月1日
研究の完了 (予想される)
2023年5月1日
試験登録日
最初に提出
2020年11月19日
QC基準を満たした最初の提出物
2020年11月26日
最初の投稿 (実際)
2020年12月4日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月28日
QC基準を満たした最後の更新が送信されました
2021年4月26日
最終確認日
2021年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- H20-01936
- 20/SS/0101 (その他の識別子：South East Scotland Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Pseudonymised data from this study will be made available for sharing with other investigators, after publication of the study's key papers.
Data will be shared through the LJMU Data Repository (http://opendata.ljmu.ac.uk/).
This is a secure institutional data repository, which is searchable on the www, it is managed by Library Services.
A DOI will be generated for datasets as they are deposited to the repository.
Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
IPD 共有時間枠
Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
IPD 共有アクセス基準
Data will be shared through the LJMU Data Repository (http://opendata.ljmu.ac.uk/).
This is a secure institutional data repository, which is searchable on the www, it is managed by Library Services.
A DOI will be generated for datasets as they are deposited to the repository.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。
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