Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults
18 июля 2022 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
240
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Lauren C Bohlen, Ph.D.
- Номер телефона: 401-863-6559
- Электронная почта: lauren_bohlen@brown.edu
Места учебы
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02912
- Рекрутинг
- Brown University
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Контакт:
- Lauren Connell Bohlen, PhD
- Номер телефона: 401-863-6559
- Электронная почта: lauren_bohlen@brown.edu
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 50 лет до 64 года (Взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Self-Paced Intensity Physical Activity
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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.
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Активный компаратор: Prescribed Moderate Intensity Physical Activity
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in total volume of structured PA
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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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.
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Measured at baseline, and months 3, 6, 9, and 12.
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Minutes per week of PA
Временное ограничение: Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
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Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.
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Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Changes in Body Weight
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
|
Assessment of self-reported body weight by study-provided scales
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Measured at baseline, and months 3, 6, 9, and 12.
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Opportunity Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's opportunity to do regular aerobic physical activity
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Measured at baseline, and months 3, 6, 9, and 12.
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Capability Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's physical and psychological capability to do regular aerobic physical activity
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Measured at baseline, and months 3, 6, 9, and 12.
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Exercise Motivation Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's motivation on the days they have made a plan to exercise
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Measured at baseline, and months 3, 6, 9, and 12.
|
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Habit of Physical Activity Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's habits regarding exercise
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Measured at baseline, and months 3, 6, 9, and 12.
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Physical Activity Identity Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's personal beliefs regarding exercise
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Measured at baseline, and months 3, 6, 9, and 12.
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Outcome Expectations for Physical Activity Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's beliefs about the consequences of exercise
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Measured at baseline, and months 3, 6, 9, and 12.
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Attitude towards Physical Activity - Affective Attitude Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's beliefs about exercise
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Measured at baseline, and months 3, 6, 9, and 12.
|
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Attitude towards Physical Activity - Instrumental Attitude Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's beliefs about exercise
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Measured at baseline, and months 3, 6, 9, and 12.
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Physical Activity Enjoyment Scale (title of questionnaire; not subscale; measuring changes in PA enjoyment)
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures how much a person enjoys exercise; scores range from 18-26 and higher scores mean more physical activity enjoyment
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Measured at baseline, and months 3, 6, 9, and 12.
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Intention Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's intention to exercise
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Measured at baseline, and months 3, 6, 9, and 12.
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Chronic Pain Screening Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures how much chronic pain a person had in the past 6 months
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Measured at baseline, and months 3, 6, 9, and 12.
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Pain Medication Use Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures the medications a person is taking for chronic pain
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Measured at baseline, and months 3, 6, 9, and 12.
|
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12 Item Short Form (SF-12) Health Survey
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures a person's views about their health
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Measured at baseline, and months 3, 6, 9, and 12.
|
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Quality of Life Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures a person's views about their quality of life and health
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Measured at baseline, and months 3, 6, 9, and 12.
|
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Activity Tracker Use Questionnaire
Временное ограничение: Measured at baseline, and months 3, 6, 9, and 12.
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Measures of use of physical activity devices, memberships, and equipment
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Measured at baseline, and months 3, 6, 9, and 12.
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EMA: Affective response to PA
Временное ограничение: Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
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Captures the shift in core affective valence (feeling good vs bad) from pre-PA to during-PA.
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Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
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EMA: Perceived autonomy
Временное ограничение: Measured weekly from date of randomization until the end of the study at week 52
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Assesses participant's perceived autonomy over exercise behavior.
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Measured weekly from date of randomization until the end of the study at week 52
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EMA: Perceived exertion
Временное ограничение: Measured daily from date of randomization until the end of the study at week 52
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Assesses participant's perceived exertion during PA.
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Measured daily from date of randomization until the end of the study at week 52
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EMA: Behavioral intention
Временное ограничение: Measured daily from date of randomization until the end of the study at week 52
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Assesses degree to which participant intends to engage in PA.
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Measured daily from date of randomization until the end of the study at week 52
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EMA: PA setting
Временное ограничение: Measured daily from date of randomization until the end of the study at week 52
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Assessed the physical and social setting in which a participant engages in physical activity.
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Measured daily from date of randomization until the end of the study at week 52
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EMA: Anticipated, remembered, and incidental affect
Временное ограничение: Measured daily from date of randomization until the end of the study at week 52
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Will assess how participant expects to feel after engaging in PA, how participant remembers feeling after engaging in PA, and how participant currently feels.
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Measured daily from date of randomization until the end of the study at week 52
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EMA: Self-Efficacy for Physical Activity
Временное ограничение: Measured daily from date of randomization until the end of the study at week 52
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Measures beliefs about capabilities to be physically active
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Measured daily from date of randomization until the end of the study at week 52
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EMA: Social Support for Exercise
Временное ограничение: Measured daily from date of randomization until the end of the study at week 52
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Measures a person's social support available to help them exercise
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Measured daily from date of randomization until the end of the study at week 52
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: David M Williams, Ph.D., Brown University School of Public Health
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
15 марта 2022 г.
Первичное завершение (Ожидаемый)
1 мая 2026 г.
Завершение исследования (Ожидаемый)
1 мая 2026 г.
Даты регистрации исследования
Первый отправленный
23 февраля 2022 г.
Впервые представлено, что соответствует критериям контроля качества
15 марта 2022 г.
Первый опубликованный (Действительный)
18 марта 2022 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 июля 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 июля 2022 г.
Последняя проверка
1 июля 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- R01AG069349 (Грант/контракт NIH США)
- F32AG074680 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .