Primary Care-Based Physical Activity for Diabetic Latinas
2020年1月9日 更新者：Britta Larsen、University of California, San Diego
Camino a La Salud: Adapting and Testing a Primary Care-Delivered Physical Activity Intervention for Latinas With Type II Diabetes
The goal of this proposal is to test the efficacy of a primary care-delivered, print-based physical activity intervention for Latinas with type II diabetes.
The investigators will test the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited through UCSD Health System primary care to either the adapted web-based physical activity intervention or standard of care, and assessing physical activity gains at six and 12 months.
The ultimate goal is to develop a print-based physical activity intervention for diabetic Latinas that could be widely disseminated through primary care.
調査の概要
詳細な説明
Studies show that adoption of regular physical activity (PA) can greatly enhance diabetes management and prevention.
Individuals who adopt a PA routine show significant improvements in clinical markers of diabetes, including HbA1c, glucose tolerance, insulin sensitivity, weight and waist circumference, and significant reductions in medication use, and also show reductions in cardiovascular risk factors and other related co-morbidities.
Incorporation of cost-effective PA interventions into primary care for diabetes treatment could therefore enhance overall health and quality of life and significantly reduce healthcare costs.
The primary aim of this study is to conduct a small randomized trial (N=80) to test the efficacy of an individually tailored culturally adapted print-based physical activity intervention integrated into primary care to increase weekly moderate-to-vigorous physical activity in Latinas with type II diabetes, compared to those receiving standard of care.
研究の種類
介入
入学 (実際)
25
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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California
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La Jolla、California、アメリカ、92093-0628
- University of California, San Diego
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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～70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:
- Have received a physician's diagnosis of type II diabetes and are currently being seen by a primary care physician
- Currently inactive, defined as participating in at least moderate intensity physical activity for less than 60 minutes per week
Exclusion Criteria:
- Medical condition that may make exercise unsafe, including congestive heart failure, severe musculoskeletal problems or pulmonary conditions, or other conditions determined by the referring physician to preclude unsupervised exercise
- Unable to receive mailed materials (do not have a mailing address)
- Unable to engage in physical activity for at least 30 minutes
- Have a current or planned pregnancy
- Planning to move from the area within the next year
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Tailored Physical Activity Intervention
Intervention group will receive Spanish-language physical activity print intervention based on SCT and Transtheoretical Model, (TTM) that emphasizes behavioral strategies for increasing activity levels.
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The Tailored Internet intervention is based on constructs of the Transtheoretical Model (TTM) and Social Cognitive Theory (SCT).
During the 6-month intervention period, participants will receive monthly mailed questionnaires that assess current motivational readiness for physical activity and other TTM and SCT constructs (e.g., process of change, self-efficacy) and monthly logs to record their current activity.
他の名前：
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アクティブコンパレータ：Standard of Care Control Group
Control group will receive standard of care through the Family Medicine clinic as well as monthly questionnaires on topics other than physical activity (e.g.
diet) to complete.
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Those assigned to the control group will continue to receive standard of care through the Family Medicine clinic.
This currently entails commonly accepted medication treatment strategies, educational materials and counseling for self-management and medication adherence, screening for depression or other conditions that would impair self-management, and national and state quality of care guidelines for lab testing and control targets (HbA1c, lipids, blood pressure).
Participants in the control group will also receive monthly questionnaires on topics other than physical activity (e.g.
diet) to fill out and return in order to have the same opportunities for compensation as those in the intervention condition.
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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 |
|---|---|---|
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Objective Changes in Physical Activity from Baseline to 6 Months
時間枠：Baseline, 6 Months (MO)
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The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from baseline to 6 months.
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Baseline, 6 Months (MO)
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Self-Report Changes in Physical Activity from Baseline to 6 Months
時間枠：Baseline, 6 Months (MO)
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The 7-Day Physical Activity Recall (PAR) will also assess self-reported changes in physical activity from baseline to 6 months.
The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities.
The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
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Baseline, 6 Months (MO)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective Changes in Physical Activity from 6 Months to 12 Months
時間枠：6 Months (MO), 12 Months (MO)
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The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from 6 to 12 months.
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6 Months (MO), 12 Months (MO)
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Self-Report Changes in Physical Activity from 6 Months to 12 Months
時間枠：6 Months (MO), 12 Months (MO)
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The 7-Day Physical Activity Recall (PAR) will also assess self-reported changes in physical activity from 6 to 12 months.
The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities.
The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
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6 Months (MO), 12 Months (MO)
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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。
捜査官
- 主任研究者：Britta Larsen, PhD、UC, San Diego Department of Family Medicine and Public Health
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8月1日
一次修了 (実際)
2019年10月1日
研究の完了 (実際)
2019年10月1日
試験登録日
最初に提出
2016年4月5日
QC基準を満たした最初の提出物
2016年4月12日
最初の投稿 (見積もり)
2016年4月18日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月13日
QC基準を満たした最後の更新が送信されました
2020年1月9日
最終確認日
2020年1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
- K01DK101650 (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?
いいえ
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