Physical Activity and Social Support Prompting Via Phone Messaging
2017年3月8日 更新者：Shinyi Wu、University of Southern California
Phone Messaging for Physical Activity and Social Support Prompting Among Low-Income Latino Patients: A Randomized Pilot Study
The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message intervention to activate 1) physical activity behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by family members or close friends.
調査の概要
詳細な説明
Despite the promise of phone-based interventions to effectively support diabetes self-management (DSM), little is known about their impact on the outcomes of highly vulnerable populations such as low-income, inner-city, racial/ethnic minorities.
And while phone-based interventions have generally been successful at reaching and engaging adults with diabetes, they have failed to do the same with family members/friends (FF) whom are a promising source of ongoing support for DSM.
The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message (ST/VM) intervention to activate 1) physical activity (PA) behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by FF.
The investigators conducted a 12-week pilot study in which participants were randomized into one of three study arms: control, phone messaging (PM), and phone messaging plus social support from FF (PM+FF).
Participants were recruited in person from a diabetes management program at a safety-net ambulatory care clinic.
All participants were given a pedometer and walking log for self-monitoring.
Participants in the PM and PM+FF arms received ST/VMs as reminders to review daily step goals and to self-monitor; explaining the benefits of regular PA, importance of regular PA to daily life, and ways to overcome commonly identified barriers to PA; asking participants to report on PA performance; providing feedback based on responses.
Participants in the PM+FF identified a FF to receive ST/VMs with suggested behaviors that are perceived as supportive by individuals making PA behavior changes.
Participants received semi-structured assessments in person at baseline, 6 weeks, and 12 weeks.
Participants were asked about the extent to which the program enhanced the participant's ability to make PA behavior changes.
The primary outcome measures were daily step counts and perceived FF social support.
研究の種類
介入
入学 (実際)
42
段階
- 適用できない
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:
- Age greater than or equal to 18 years
- Diagnosis of type 2 diabetes
- No medical conditions restricting patient from beginning a walking program
- Preferred language of English or Spanish, self-identifies as a Hispanic
- Ability to walk without the use of assistive devices such as canes or walkers
- Available to attend three interviews at the clinic
- Does not plan to move away from the region or be out of the country during the next three months
- Has a working phone where they can receive regular short text or voice messages for three months
Exclusion Criteria:
- Pregnant or breastfeeding women
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 |
|---|---|
|
他の：Control
Pedometers and walking logs
|
Participants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day.
Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day.
Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day.
|
|
実験的：Phone Messaging
|
Participants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day.
Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day.
Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day.
Participants received short text or voice messages (depending on participant preference) as reminders to review daily step goals and to self-monitor; explaining the benefits of regular physical activity, importance of regular physical activity to daily life, and ways to overcome commonly identified barriers to physical activity; asking participants to report on their physical activity performance; providing feedback based on responses.
|
|
実験的：Phone Messaging + Family/Friend Support
|
Participants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day.
Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day.
Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day.
Participants received short text or voice messages (depending on participant preference) as reminders to review daily step goals and to self-monitor; explaining the benefits of regular physical activity, importance of regular physical activity to daily life, and ways to overcome commonly identified barriers to physical activity; asking participants to report on their physical activity performance; providing feedback based on responses.
Participants identified a family member or close friend (FF) to receive short text or voice messages (depending on FF preference) with suggested behaviors that are perceived as supportive by individuals making physical activity behavior changes.
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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 in average daily steps assessed by pedometers
時間枠：Baseline, 6 weeks, 12 weeks
|
Change in average daily steps assessed using pedometer 7-day data storage
|
Baseline, 6 weeks, 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in body mass index
時間枠：Baseline, 6 weeks, 12 weeks
|
Change in Body Mass Index, which was calculated as weight (in kilograms) over height squared (in centimeters)
|
Baseline, 6 weeks, 12 weeks
|
|
Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
時間枠：Baseline, 6 weeks, 12 weeks
|
Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
|
Baseline, 6 weeks, 12 weeks
|
|
Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
時間枠：Baseline, 6 weeks, 12 weeks
|
Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
|
Baseline, 6 weeks, 12 weeks
|
|
Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
時間枠：Baseline, 6 weeks, 12 weeks
|
Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
|
Baseline, 6 weeks, 12 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in perceived usefulness assessed using patient interviews
時間枠：6 weeks, 12 weeks
|
At the 6- and 12-week follow-up interviews, participants were asked a series of unstructured questions regarding the extent to which the program enhanced a participant's ability to make physical activity behavior changes.
These questions inquired about participants' thoughts on setting PA goals, self-monitoring, educational and feedback ST/VMs, and the idea of using ST/VMs to communicate with patients about PA behavior change.
For participants in the PM+FF arms, the questions also inquired about supportive behaviors exhibited by FF since the start of the program and participants' thoughts on the idea of using ST/VMs to communicate with FF about patients' PA behavior changes.
Investigators also asked if participants would be willing to participate in a similar program in the future and if participants would be willing to recommend the program to other patients.
The latter two were yes/no questions.
|
6 weeks, 12 weeks
|
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Change in perceived usability of pedometers assessed via patient interviews
時間枠：Baseline, 6 weeks, 12 weeks
|
Semi-structured patient interview questions inquiring about the degree to which participants perceived the pedometers to be easy to use
|
Baseline, 6 weeks, 12 weeks
|
|
Change in perceived barriers to receipt of and engagement with ST/VMs assessed via patient interviews
時間枠：6 weeks, 12 weeks
|
Semi-structured patient interview questions inquiring about participants' perceived barriers to the receipt of and engagement with ST/VMs
|
6 weeks, 12 weeks
|
|
Change in engagement with ST/VMs requiring a response assessed via call logs
時間枠：6 weeks, 12 weeks
|
Percentage of times that participants responded to ST/VMs requiring a response
|
6 weeks, 12 weeks
|
|
Change in receipt of ST/VMs assessed via self-report and call logs
時間枠：6 weeks, 12 weeks
|
Percentage of short text messages delivered that were received assessed via self-report, and percentage of voice messages that were received assessed via call logs
|
6 weeks, 12 weeks
|
|
Change in non-compliance with wearing pedometer assessed via pedometer and walking log
時間枠：Baseline, 6 weeks, 12 weeks
|
Percentage of patients that did not wear the pedometer for a minimum of three consecutive days for at least 10 hours per day.
This data will be obtained using the pedometer 7-day memory storage and participants' self-reported hours of use.
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Baseline, 6 weeks, 12 weeks
|
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Recruitment and retention rates assessed via recruitment and follow-up logs
時間枠：1 day (Recruitment), 6 weeks, 12 weeks
|
Percentage of patients that were screened, were eligible to participate, and enrolled in the study.
Percentage of patients who completed the 6-week and 12-week follow-up assessments.
|
1 day (Recruitment), 6 weeks, 12 weeks
|
|
Sufficiency or restrictiveness of eligibility criteria assessed via recruitment logs
時間枠：1 day (Recruitment)
|
Percentage of patients that were screened, but were ineligible to participate and the reasons why
|
1 day (Recruitment)
|
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。
協力者
捜査官
- 主任研究者：Shinyi Wu, Ph.D.、University of Southern California
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
2015年4月1日
一次修了 (実際)
2015年11月1日
研究の完了 (実際)
2015年11月1日
試験登録日
最初に提出
2016年4月12日
QC基準を満たした最初の提出物
2016年7月29日
最初の投稿 (見積もり)
2016年8月1日
学習記録の更新
投稿された最後の更新 (実際)
2017年3月13日
QC基準を満たした最後の更新が送信されました
2017年3月8日
最終確認日
2017年3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
- HS-13-00471
- 3U54NS081764-03S1 (米国 NIH グラント/契約)
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
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