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Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

2022年7月18日 更新者：David M. Williams、Brown University

Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT

We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight [25 < BMI < 30]) or obese (30 < BMI <40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (予想される)

240

段階

  • フェーズ2

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

研究場所

  • アメリカ
    • Rhode Island
      • Providence、Rhode Island、アメリカ、02912
        • 募集
        • Brown University
        • コンタクト：

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

50年～64年 (大人)

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 50-64
  • BMI 25-40
  • Sedentary or low-active, defined as participating in < 60 min/week of structured exercise
  • Has a smart phone that can connect to the internet at least once every few days and is compatible with smartphone app

Exclusion criteria:

  • Medical symptoms/conditions that may make unsupervised exercise unsafe (specific exclusion criteria were developed in consultation with a cardiologist and are listed below):

    • Past 3-month overnight hospitalization
    • Past 3-month treatment for heart disease, including bypass or valve surgery, interventional procedure(s) such as angioplasty (stent), or a pacemaker or other implanted device to control your heart rate or rhythm
    • Past 3-month inability to walk without assistance due to stroke, transient ischemic attack (TIA), or neurologic or spinal injury
    • Past 6-month angina, chest pain, or chest discomfort either at rest or with exertion/activity
    • Past 6-month peripheral vascular disease such as claudication which causes pain in the legs when walking briskly
    • Past 6-month seizure
    • Past 6-month overnight hospitalization due to respiratory disease
    • Past 6-month lightheadedness, vertigo, dizziness, or fainting
    • Heart, lung, abdominal, joint, or orthopedic surgeries in the past 12-months, or pending or scheduled in the next 12 months
    • Takes insulin and/or medication that affects the secretion of insulin
    • Exercise-induced asthma that prevents brisk walking
    • Takes anticonvulsant medication or medication to treat/control seizures
    • Diagnosed with cystic fibrosis
    • Bone or joint problems that make you unable to walk for at least 30 minutes
    • Physician has said not to exercise because of bone or joint problems
    • Physician has said a hip or knee replacement will be needed in the next 12 months
    • Anything other medical symptoms/condition that prevents participant from being physical unable to walk without assistance continuously for 30 minutes
  • Currently taking or planning on taking medications that affect HR, such as beta or calcium channel blockers or digoxin, as HR will be used to determine the moderate intensity range for participants assigned to that condition
  • Past 12-month overnight psychiatric hospitalization
  • Currently pregnant or planning to become pregnant in the next year
  • Currently participating in any exercise or weight-loss research studies
  • Household member is participating in this study
  • Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box
  • Unable to receive materials in the mail at residential mailing address
  • Does not plan to live in Rhode Island for the next 12 months
  • Unable to speak, read, and/or write fluently in English
  • Smokers will be eligible, but smoking status will be included as a covariate in analyses

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：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Self-Paced Intensity Physical Activity
行動：Self-Paced Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in self-selected intensity PA.
アクティブコンパレータ：Prescribed Moderate Intensity Physical Activity
行動：Prescribed Moderate Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in moderate intensity PA consistent with national guidelines.

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 total volume of structured PA
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Minutes of PA weighted by intensity, expressed in metabolic equivalent (MET) minutes as determined by accelerometers (Actigraph [model wGT3x-BT]) worn during one-week periods.
Measured at baseline, and months 3, 6, 9, and 12.
Minutes per week of PA
時間枠：Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.
Measured daily from date of randomization for 52 weeks based on participant initiation of exercise

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes in Body Weight
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Assessment of self-reported body weight by study-provided scales
Measured at baseline, and months 3, 6, 9, and 12.

その他の成果指標

結果測定
メジャーの説明
時間枠
Opportunity Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's opportunity to do regular aerobic physical activity
Measured at baseline, and months 3, 6, 9, and 12.
Capability Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's physical and psychological capability to do regular aerobic physical activity
Measured at baseline, and months 3, 6, 9, and 12.
Exercise Motivation Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's motivation on the days they have made a plan to exercise
Measured at baseline, and months 3, 6, 9, and 12.
Habit of Physical Activity Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's habits regarding exercise
Measured at baseline, and months 3, 6, 9, and 12.
Physical Activity Identity Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's personal beliefs regarding exercise
Measured at baseline, and months 3, 6, 9, and 12.
Outcome Expectations for Physical Activity Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about the consequences of exercise
Measured at baseline, and months 3, 6, 9, and 12.
Attitude towards Physical Activity - Affective Attitude Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about exercise
Measured at baseline, and months 3, 6, 9, and 12.
Attitude towards Physical Activity - Instrumental Attitude Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about exercise
Measured at baseline, and months 3, 6, 9, and 12.
Physical Activity Enjoyment Scale (title of questionnaire; not subscale; measuring changes in PA enjoyment)
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures how much a person enjoys exercise; scores range from 18-26 and higher scores mean more physical activity enjoyment
Measured at baseline, and months 3, 6, 9, and 12.
Intention Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's intention to exercise
Measured at baseline, and months 3, 6, 9, and 12.
Chronic Pain Screening Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures how much chronic pain a person had in the past 6 months
Measured at baseline, and months 3, 6, 9, and 12.
Pain Medication Use Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures the medications a person is taking for chronic pain
Measured at baseline, and months 3, 6, 9, and 12.
12 Item Short Form (SF-12) Health Survey
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's views about their health
Measured at baseline, and months 3, 6, 9, and 12.
Quality of Life Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's views about their quality of life and health
Measured at baseline, and months 3, 6, 9, and 12.
Activity Tracker Use Questionnaire
時間枠：Measured at baseline, and months 3, 6, 9, and 12.
Measures of use of physical activity devices, memberships, and equipment
Measured at baseline, and months 3, 6, 9, and 12.
EMA: Affective response to PA
時間枠：Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
Captures the shift in core affective valence (feeling good vs bad) from pre-PA to during-PA.
Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
EMA: Perceived autonomy
時間枠：Measured weekly from date of randomization until the end of the study at week 52
Assesses participant's perceived autonomy over exercise behavior.
Measured weekly from date of randomization until the end of the study at week 52
EMA: Perceived exertion
時間枠：Measured daily from date of randomization until the end of the study at week 52
Assesses participant's perceived exertion during PA.
Measured daily from date of randomization until the end of the study at week 52
EMA: Behavioral intention
時間枠：Measured daily from date of randomization until the end of the study at week 52
Assesses degree to which participant intends to engage in PA.
Measured daily from date of randomization until the end of the study at week 52
EMA: PA setting
時間枠：Measured daily from date of randomization until the end of the study at week 52
Assessed the physical and social setting in which a participant engages in physical activity.
Measured daily from date of randomization until the end of the study at week 52
EMA: Anticipated, remembered, and incidental affect
時間枠：Measured daily from date of randomization until the end of the study at week 52
Will assess how participant expects to feel after engaging in PA, how participant remembers feeling after engaging in PA, and how participant currently feels.
Measured daily from date of randomization until the end of the study at week 52
EMA: Self-Efficacy for Physical Activity
時間枠：Measured daily from date of randomization until the end of the study at week 52
Measures beliefs about capabilities to be physically active
Measured daily from date of randomization until the end of the study at week 52
EMA: Social Support for Exercise
時間枠：Measured daily from date of randomization until the end of the study at week 52
Measures a person's social support available to help them exercise
Measured daily from date of randomization until the end of the study at week 52

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。

スポンサー

Brown University

協力者

National Institute on Aging (NIA)

捜査官

  • 主任研究者：David M Williams, Ph.D.、Brown University School of 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)

2022年3月15日

一次修了 (予想される)

2026年5月1日

研究の完了 (予想される)

2026年5月1日

試験登録日

最初に提出

2022年2月23日

QC基準を満たした最初の提出物

2022年3月15日

最初の投稿 (実際)

2022年3月18日

学習記録の更新

投稿された最後の更新 (実際)

2022年7月20日

QC基準を満たした最後の更新が送信されました

2022年7月18日

最終確認日

2022年7月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • R01AG069349 (米国 NIH グラント/契約)
  • F32AG074680 (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

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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