Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing
Targeting Diurnal Exercise Timing to Increase Exercise Levels Among Adults With Obesity: A Randomized, Crossover Pilot
연구 개요
상태
정황
상세 설명
Performing at least 150 minutes of moderate intensity physical activity per week is associated with many health improvements. Some research suggests that people who exercise at the same time day-to-day perform more physical activity than those who exercise at variable times day-to-day, but it is not yet known if asking people to exercise at the same time day-to-day is helpful for becoming more active and whether there is a specific time of day (e.g., morning vs. evening) that is most helpful. Importantly, it is also not yet known whether people are able and willing to exercise at a specific time day-to-day. This study thus seeks to learn more about how feasible, acceptable, and helpful it is to exercise at an assigned time.
The study will last for 4 months total. Interested participants will be asked to attend an orientation visit at the research center to learn more about the study and will wear a physical activity monitor for 1 week to verify eligibility. Participants who enroll in the study will then complete a 45-minute session with study staff (in person or via videoconferencing) to learn strategies for safely increasing physical and will be asked to walk at a moderate intensity for at least 15 consecutive minutes every day during three, 3-week periods (9 weeks total). Each participant will be asked to perform this walking in the morning (5:00-10:00 AM) for one of the 3-week periods, in the evening (5:00-10:00 PM) for one of the 3-week periods, and at a time of their choice for one of the 3-week periods. Between each 3-week period with a daily exercise goal, there will be a 2-week break period with no exercise goal. Participants will be asked to wear a physical activity sensor on an elastic band around their waist during all waking hours for the full study duration to monitor their physical activity levels. They will also be emailed a survey about their physical activity each night during each of the 3-week exercise periods. Participants will receive a weekly email each week to provide support and encouragement for increasing their physical activity, and to report on how many days they wore the physical activity sensor. Lastly, participants will complete a visit at the research center at the end of the study to complete questionnaires about their experiences.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Weight Control and Diabetes Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 35 to 65 years of age
- BMI between 30.0 and 50.0 kg/m2
- Able to read and write English
- Home access to the internet via computer or smart phone
- Ability to walk 10 consecutive min without assistance
- Currently performing <50 min/week of moderate intensity physical activity per week (verified via an accelerometer)
Exclusion Criteria:
- Current participation in another formal weight management or physical activity intervention
- Pregnant, <6 month postpartum, or planning to become pregnant in the next 3 months
- Presence of an uncontrolled mental health condition
- Extended absence (e.g., extended vacation) from the Providence area during the study
- Presence of a medical condition for which increased exercise may be contraindicated
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Morning exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
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Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 AM and 10 AM each day.
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실험적: Evening exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
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Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 PM and 10 PM each day.
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활성 비교기: Time of choice exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
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Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes at a time of their choice each day.
This time can change day-to-day.
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간섭 없음: No exercise period
During the two-week "washout" (i.e., break) periods between the exercise interventions, participants will not have an exercise goal.
Participants will continue to receive weekly emails and wear a physical activity sensor daily.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Consent rates
기간: Pre-intervention
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Percent of eligible individuals electing to enroll in the study
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Pre-intervention
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Study completion rates
기간: At study completion, an average of 14 weeks
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Percent of consented individuals completing the post-intervention assessment
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At study completion, an average of 14 weeks
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Physical activity timing adherence rates
기간: Through study completion, an average of 14 weeks
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Percent of moderate intensity physical activity bouts per 3-week condition completed during the assigned time (i.e., 5-10 AM for the morning condition, 5-10 PM for the evening condition)
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Through study completion, an average of 14 weeks
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Acceptability questionnaire
기간: At study completion, an average of 14 weeks
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17-item questionnaire assessing satisfaction with and perceived helpfulness of prescribed physical activity timing overall and specifically in the morning and evening
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At study completion, an average of 14 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Average daily physical activity minutes
기간: Through study completion, an average of 14 weeks
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Average daily minutes of moderate-to-vigorous physical activity per week per each 3-week timing condition as measured by a hip-worn accelerometer
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Through study completion, an average of 14 weeks
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Average days per week with at least 15 min of physical activity
기간: Through study completion, an average of 14 weeks
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Average number of days per week with at least 15 minutes of moderate-to-vigorous physical activity per each 3-week timing condition as measured by a hip-worn accelerometer
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Through study completion, an average of 14 weeks
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Barriers and facilitators of physical activity questionnaire
기간: Through study completion, an average of 14 weeks
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Questionnaire administered nightly during each 3-week exercise period that assesses the presence and intensity of several barriers to (e.g., fatigue, scheduling conflicts) and facilitators of (e.g., habit, enjoyment) physical activity.
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Through study completion, an average of 14 weeks
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Preferred physical activity timing questionnaire
기간: At study completion, an average of 14 weeks
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Two self-report questions assessing preferred physical activity timing
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At study completion, an average of 14 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Leah Schumacher, PhD, The Miriam Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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