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Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morning exercise goal
Evening exercise goal
Time of choice exercise goal
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring physical activity, exercise

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

Morning exercise

Evening exercise

Time of choice exercise

No exercise period

Arm Description

Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.

Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.

Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.

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.

Outcomes

Primary Outcome Measures

Consent rates
Percent of eligible individuals electing to enroll in the study
Study completion rates
Percent of consented individuals completing the post-intervention assessment
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)
Acceptability questionnaire
17-item questionnaire assessing satisfaction with and perceived helpfulness of prescribed physical activity timing overall and specifically in the morning and evening

Secondary Outcome Measures

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
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
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.
Preferred physical activity timing questionnaire
Two self-report questions assessing preferred physical activity timing

Full Information

First Posted
September 8, 2021
Last Updated
March 28, 2022
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05073042
Brief Title
Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing
Official Title
Targeting Diurnal Exercise Timing to Increase Exercise Levels Among Adults With Obesity: A Randomized, Crossover Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
physical activity, exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morning exercise
Arm Type
Experimental
Arm Description
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
Arm Title
Evening exercise
Arm Type
Experimental
Arm Description
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
Arm Title
Time of choice exercise
Arm Type
Active Comparator
Arm Description
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
Arm Title
No exercise period
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Morning exercise goal
Intervention Description
Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 AM and 10 AM each day.
Intervention Type
Behavioral
Intervention Name(s)
Evening exercise goal
Intervention Description
Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 PM and 10 PM each day.
Intervention Type
Behavioral
Intervention Name(s)
Time of choice exercise goal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Consent rates
Description
Percent of eligible individuals electing to enroll in the study
Time Frame
Pre-intervention
Title
Study completion rates
Description
Percent of consented individuals completing the post-intervention assessment
Time Frame
At study completion, an average of 14 weeks
Title
Physical activity timing adherence rates
Description
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)
Time Frame
Through study completion, an average of 14 weeks
Title
Acceptability questionnaire
Description
17-item questionnaire assessing satisfaction with and perceived helpfulness of prescribed physical activity timing overall and specifically in the morning and evening
Time Frame
At study completion, an average of 14 weeks
Secondary Outcome Measure Information:
Title
Average daily physical activity minutes
Description
Average daily minutes of moderate-to-vigorous physical activity per week per each 3-week timing condition as measured by a hip-worn accelerometer
Time Frame
Through study completion, an average of 14 weeks
Title
Average days per week with at least 15 min of physical activity
Description
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
Time Frame
Through study completion, an average of 14 weeks
Title
Barriers and facilitators of physical activity questionnaire
Description
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.
Time Frame
Through study completion, an average of 14 weeks
Title
Preferred physical activity timing questionnaire
Description
Two self-report questions assessing preferred physical activity timing
Time Frame
At study completion, an average of 14 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah Schumacher, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing

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