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An Engagement Engine for Fitness Trackers (iTrackFitnes)

2021年2月22日 更新者:Joseph C. Kvedar、Massachusetts General Hospital

Evaluating an Engagement Engine to Support Long Term Use of Fitness Trackers and Sustain Physical Activity

The iTrackFitness study aims to test the "engagement engine" that was developed from activity tracker and survey data gathered during phase I of the study. For the current phase the "engagement engine" will support successful and sustained engagement with health trackers thereby increasing physical activity.

調査の概要

状態

完了

詳細な説明

Due to the growing interest in tracking personal health and wellness information, the use of wearable fitness trackers is becoming a necessary tool in providing the tracking data. However, the potential benefits of the tool can be fully realized only if the adoption and use of the tracker is sustained.

The decision to engage in physical activity (or not) is complex, and therefore, the investigators attempt to engage people in a physical activity program will consider adopting an individualized approach to barrier management which takes into account personal beliefs and perceptions regarding physical activity, setting goals in addition to using an "engagement engine" designed specifically for this study. The primary objective of the phase 2 of this study is to test an "engagement engine" that will support successful and sustained engagement with health trackers thereby increasing physical activity.

The study will be recruiting a total of 138 participants from the general public via Massachusetts General Hospital (MGH) research broadcast e-serve list, the study website, flyers and study informational tables at MGH-affiliated health clinics. Participants can enroll in the study by consenting remotely where the screening and consenting will take place online through the study website.

After the consenting process, enrolled participants will be instructed on how to download the FitBit smartphone application and provide the study staff authorization to collect step data from their tracker. The enrollment process will involve completing a set of enrollment questions related to general health, barriers to physical activity, exercise regulation, Prochaska's stage of change, demographics and technology use via a web link on the study website. Next a research analyst will mail a copy of the consent form, wearable activity tracker (Fitbit Charge) and device instructions via traceable mail to the research participants. For participants who enroll from the informational tables, the research analyst will provide them the FitBit in person. Once confirmed that participants have received their device, the participant will be contacted by the Partners Connected Health (PCH) study staff to conduct a brief phone interview to determine a personalized goal that can be used for targeted, personalized messages as needed.

Participants will be enrolled in the study for (24 weeks) and for the first week the engagement engine will calculate the average step count and use data from the enrollment questionnaire to recommend a physical activity goal. During the study, the engagement engine will recommend a daily physical activity goal and will assess the user's levels of engagement with the activity tracker. At week 12, participants will be sent a midpoint questionnaire and at week 24 the closeout questionnaire will be sent to the participant.

The investigators do not foresee any significant risks for study participants and participants may not directly benefit from this the study. It is hoped that data collected from this study will allow the investigators to assess the engagement engine that could potentially be used to help individuals remain engaged with their physical activity tracker thereby sustaining regular physical activity.

The risk for potential inadvertent release of Protected Health Information is taken very seriously. Investigators have taken several steps to minimize this risk as much as possible. Data collected on paper will be stored in a locked cabinet at PCH, accessible only to research staff. For the purposes of this study, participants will be asked to authorize the PCH database to access and store activity data from the activity tracker server. This is done using a secure, OAUTH procedure in which participants will be asked to enter their account username and password. The OAUTH process does not store this information on the PCH/study website, making this a secure and confidential method for participants to enable the PCH study staff to have access to their activity data.

Activity data retrieved from the FitBit app will be stored on password protected server maintained by PCH Information Systems. At the conclusion of the study participants can change their account user settings on the study website and revoke PCH study database access to their account and data. Participants will be instructed on this process at the close-out of the study.

研究の種類

介入

入学 (実際)

184

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

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Massachusetts General Hospital

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~95年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Ages 18+ years of age
  • Body Mass Index (BMI) 25-40 kg/m2
  • Interest in using a fitness tracker for the duration of the study (24 weeks)
  • Possess a smartphone, tablet or computer with the FiBit app
  • Consent to undergo a phone interview with a member of the study staff
  • Ability to receive text messages on their phone
  • Fluency in English

Exclusion Criteria:

  • Self-reported eating disorder and/or other psychiatric disorders
  • Pregnancy or plans to get pregnant within 6 months of enrollment
  • Disability, dementia or neurological deficits, and other medical or surgical conditions preventing participants from engaging in physical activity
  • Serious co-morbid conditions (e.g., terminal cancers, end-stage renal disease) that preclude safe participation in moderate levels of physical activity

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:他の
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • 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
他の:Machine Learning Algorithm
Single group participants that will use the algorithm to be engaged in using their fitness tracker.
The algorithm will help participants improve physical activity by sustaining long term engagement with their fitness tracker.
他の名前:
  • Engagement Engine

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
Engagement level with the tracker
時間枠:24 weeks
To assess the level of participant's engagement with physical activity tracker
24 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Physical Activity
時間枠:24 weeks
To assess participant's change in physical activity from baseline throughout the remaining 23 weeks in the study via step data collected from the FitBit
24 weeks
Change in Self-efficacy scale for Physical Activity
時間枠:24 weeks
To assess participant's change in self-efficacy to be physically active, this questionnaire will be given at 0 and 24 weeks
24 weeks
Change in Barriers to Being Active Questionnaire
時間枠:24 weeks
To assess participant's change in perception of barriers to physical activity, this questionnaire will be administered at 0 and 24 weeks
24 weeks

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。

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)

2016年1月1日

一次修了 (実際)

2018年4月1日

研究の完了 (実際)

2020年7月1日

試験登録日

最初に提出

2016年9月12日

QC基準を満たした最初の提出物

2016年11月8日

最初の投稿 (見積もり)

2016年11月9日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月24日

QC基準を満たした最後の更新が送信されました

2021年2月22日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2016P001506

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?

未定

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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