- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT05073042
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
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Rhode Island
-
Providence, Rhode Island, Egyesült Államok, 02903
- Weight Control and Diabetes Research Center
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: Morning exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
|
Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 AM and 10 AM each day.
|
Kísérleti: Evening exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
|
Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 PM and 10 PM each day.
|
Aktív összehasonlító: Time of choice exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
|
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.
|
Nincs beavatkozás: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Consent rates
Időkeret: Pre-intervention
|
Percent of eligible individuals electing to enroll in the study
|
Pre-intervention
|
Study completion rates
Időkeret: At study completion, an average of 14 weeks
|
Percent of consented individuals completing the post-intervention assessment
|
At study completion, an average of 14 weeks
|
Physical activity timing adherence rates
Időkeret: Through study completion, an average of 14 weeks
|
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)
|
Through study completion, an average of 14 weeks
|
Acceptability questionnaire
Időkeret: At study completion, an average of 14 weeks
|
17-item questionnaire assessing satisfaction with and perceived helpfulness of prescribed physical activity timing overall and specifically in the morning and evening
|
At study completion, an average of 14 weeks
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Average daily physical activity minutes
Időkeret: Through study completion, an average of 14 weeks
|
Average daily minutes of moderate-to-vigorous physical activity per week per each 3-week timing condition as measured by a hip-worn accelerometer
|
Through study completion, an average of 14 weeks
|
Average days per week with at least 15 min of physical activity
Időkeret: Through study completion, an average of 14 weeks
|
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
|
Through study completion, an average of 14 weeks
|
Barriers and facilitators of physical activity questionnaire
Időkeret: Through study completion, an average of 14 weeks
|
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.
|
Through study completion, an average of 14 weeks
|
Preferred physical activity timing questionnaire
Időkeret: At study completion, an average of 14 weeks
|
Two self-report questions assessing preferred physical activity timing
|
At study completion, an average of 14 weeks
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Leah Schumacher, PhD, The Miriam Hospital
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 20-01292
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Morning exercise goal
-
Boston University Charles River CampusBefejezveTérd OsteoarthritisEgyesült Államok
-
Rehaklinik Zihlschlacht AGLuzerner KantonsspitalIsmeretlen
-
University of RochesterToborzás
-
University of California, BerkeleyBefejezveA fizikai aktivitás | Mozgásszegény életmódEgyesült Államok
-
University of British ColumbiaLaval University; Université de MontréalToborzásObstruktív alvási apnoeKanada
-
Brigham and Women's HospitalNational Institute on Aging (NIA); Cambia Health FoundationBefejezveMotivációs interjú | Sürgősségi osztály | Előzetes gondozási tervezésEgyesült Államok
-
Gazi UniversityBefejezveCerebrális bénulásPulyka
-
University of RochesterBefejezveAkut mieloid leukémiaEgyesült Államok
-
Northwestern UniversityBefejezve
-
University of California, BerkeleyBefejezveA fizikai aktivitás | Mozgásszegény életmódEgyesült Államok