低所得、II 型糖尿病、ヒスパニック系人口における健康のための mHealth アプリの有効性
低所得、II 型糖尿病、ヒスパニック系の健康に対する mHealth アプリの有効性
The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
California
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San Diego、California、アメリカ、92182
- 募集
- San Diego State University
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コンタクト:
- Robert J Castro, BS
- 電話番号:6193636120
- メール:rcastro0271@sdsu.edu
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主任研究者:
- Mee Young Hong, PhD
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主任研究者:
- Robert J Castro, BS
-
コンタクト:
- Mee Young Hong, PhD
- 電話番号:6195942392
- メール:mhong2@sdsu.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Diagnosed with type II diabetes
- Between the age of 18-64
- BMI ≥ 27
- Individual annual income less than $47,520 [Covered CA income guidelines and salary restrictions]
- Hispanic and/or Latinx origin
- Monitors blood glucose regularly
- Owns or has access to a bathroom weight scale
- Owns a smartphone and willing to download mobile apps
Exclusion Criteria:
- Does not check blood glucose at least once per day
- On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.
Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are okay
研究計画
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:階乗代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし:コントロール
|
|
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実験的:ウェイトウォッチャー (WW)
|
Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites) |
|
実験的:健康アプリ
|
Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites) |
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 |
|---|---|---|
|
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months
時間枠:6 months
|
Determine if mHealth apps-Weight Watchers (WW) and Healthi app-are an effective weight loss modality compared to standard weight loss program (control) |
6 months
|
|
Most effect intervention for weight loss in first 3 months
時間枠:6 months
|
Compare the three interventions, mHealth apps and control, against each other to determine which is most effective at achieving the maximum amount of weight loss within the first three months |
6 months
|
|
Most effective intervention for weight loss by 6 months
時間枠:6 months
|
Compare and determine which intervention leads to the highest weight loss maintenance after six months |
6 months
|
|
Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
時間枠:6 months
|
Compare and determine which intervention promotes self-efficacy in weight management |
6 months
|
|
Long term diabetes improvement via A1c
時間枠:6 months
|
Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
時間枠:6 months
|
Comparing the three interventions to determine which leads to greater quality of life (QOL) |
6 months
|
|
mhealthy app preference assessed by questionnaire
時間枠:6 months
|
Which mHealth app is more economically feasible for the participants and if feasibility changes after app usage. Outcome will be assessed with a questionnaire asking if the participant can afford the app. |
6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。