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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Rhode Island
-
Providence, Rhode Island, États-Unis, 02903
- Weight Control and Diabetes Research Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Consent rates
Délai: Pre-intervention
|
Percent of eligible individuals electing to enroll in the study
|
Pre-intervention
|
|
Study completion rates
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Average daily physical activity minutes
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Leah Schumacher, PhD, The Miriam Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20-01292
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .