Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing

Sponsor
The Miriam Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05073042
Collaborator
(none)
15
Enrollment
1
Location
4
Arms
10.8
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Morning exercise goal
  • Behavioral: Evening exercise goal
  • Behavioral: Time of choice exercise goal
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Targeting Diurnal Exercise Timing to Increase Exercise Levels Among Adults With Obesity: A Randomized, Crossover Pilot
Actual Study Start Date :
Oct 6, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Morning exercise

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

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.

Experimental: Evening exercise

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

Behavioral: 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.

Active Comparator: Time of choice exercise

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

Behavioral: 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.

No 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.

Outcome Measures

Primary Outcome Measures

  1. Consent rates [Pre-intervention]

    Percent of eligible individuals electing to enroll in the study

  2. Study completion rates [At study completion, an average of 14 weeks]

    Percent of consented individuals completing the post-intervention assessment

  3. Physical activity timing adherence rates [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)

  4. Acceptability questionnaire [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

Secondary Outcome Measures

  1. Average daily physical activity minutes [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

  2. Average days per week with at least 15 min of physical activity [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

  3. Barriers and facilitators of physical activity questionnaire [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.

  4. Preferred physical activity timing questionnaire [At study completion, an average of 14 weeks]

    Two self-report questions assessing preferred physical activity timing

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Weight Control and Diabetes Research CenterProvidenceRhode IslandUnited States02903

Sponsors and Collaborators

  • The Miriam Hospital

Investigators

  • Principal Investigator: Leah Schumacher, PhD, The Miriam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT05073042
Other Study ID Numbers:
  • 20-01292
First Posted:
Oct 11, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Miriam Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021