Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing

Obesity Clinical Trial

Official title:

Targeting Diurnal Exercise Timing to Increase Exercise Levels Among Adults With Obesity: A Randomized, Crossover Pilot

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05073042
• Other study ID #: 20-01292
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2021
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study seeks to learn more about people's experiences with being asked to exercise consistently at a specific time of the day (e.g., in the morning) and whether a certain exercise time is most helpful for becoming more active. All participants will be asked to walk for at least 15 minutes per day at a specified time of day (morning, evening, or time of choice) for 3 weeks each (9 weeks of walking total). Each 3-week exercise period will be separated by 2 weeks with no exercise goal. Participants will be emailed a brief survey about barriers/facilitators to exercise each night during the exercise periods and will receive a weekly email that provides support and encouragement for increasing physical activity. Participants will also wear a physical activity monitor on their waist each day during the study to measure physical activity. Participants will complete questionnaires about their experiences at the end of the study.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Morning exercise goal
Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 AM and 10 AM each day.
• Evening exercise goal
Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 PM and 10 PM each day.
• Time of choice exercise goal
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.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consent rates	Percent of eligible individuals electing to enroll in the study	Pre-intervention
Primary	Study completion rates	Percent of consented individuals completing the post-intervention assessment	At study completion, an average of 14 weeks
Primary	Physical activity timing adherence rates	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
Primary	Acceptability questionnaire	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
Secondary	Average daily physical activity minutes	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
Secondary	Average days per week with at least 15 min of physical activity	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
Secondary	Barriers and facilitators of physical activity questionnaire	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
Secondary	Preferred physical activity timing questionnaire	Two self-report questions assessing preferred physical activity timing	At study completion, an average of 14 weeks