ObesityNCT05073042
Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing
A study testing Morning exercise goal, Evening exercise goal and Time of choice exercise goal in people with Obesity, run by The Miriam Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Morning exercise goal, Evening exercise goal and Time of choice exercise goal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Targeting Diurnal Exercise Timing to Increase Exercise Levels Among Adults With Obesity: A Randomized, Crossover Pilot
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Morning exercise goal, Evening exercise goal, Time of choice exercise goal
- Keywords
- physical activity, exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning exercise goalBehavioural
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 goalBehavioural
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 goalBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Morning exercise | Experimental | Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily. Receives: Behavioral: Morning exercise goal |
| Evening exercise | Experimental | Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily. Receives: Behavioral: Evening exercise goal |
| Time of choice exercise | Active comparator | Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily. Receives: Behavioral: Time of choice exercise goal |
| No exercise period | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rates
Percent of eligible individuals electing to enroll in the study
Measured: Pre-intervention
Study completion rates
Percent of consented individuals completing the post-intervention assessment
Measured: At study completion, an average of 14 weeks
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)
Measured: Through study completion, an average of 14 weeks
Acceptability questionnaire
17-item questionnaire assessing satisfaction with and perceived helpfulness of prescribed physical activity timing overall and specifically in the morning and evening
Measured: At study completion, an average of 14 weeks
Secondary outcomes (4)
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
Measured: Through study completion, an average of 14 weeks
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
Measured: Through study completion, an average of 14 weeks
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.
Measured: Through study completion, an average of 14 weeks
Preferred physical activity timing questionnaire
Two self-report questions assessing preferred physical activity timing
Measured: At study completion, an average of 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start6 Oct 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leah Schumacher, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073042
- Sponsor's protocol ID
- 20-01292
- Status last verified
- Aug 2021
- First submitted
- 8 Sep 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Diurnal Exercise Timing to Increase Exercise Levels Among Adults With Obesity: A Randomized, Crossover Pilot
- ClinicalTrials.gov ID
- NCT05073042
- Acronym / sponsor ID
- 20-01292
- Conditions
- Obesity
- Keywords
- physical activity, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Morning exercise | Experimental | Behavioral: Morning exercise goalParticipants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily. |
| Evening exercise | Experimental | Behavioral: Evening exercise goalParticipants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily. |
| Time of choice exercise | Active comparator | Behavioral: Time of choice exercise goalParticipants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily. |
| No exercise period | No intervention | –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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning exercise goalParticipants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 AM and 10 AM each day. | Behavioural | Morning exercise |
| Evening exercise goalParticipants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 PM and 10 PM each day. | Behavioural | Evening exercise |
| Time of choice exercise goalParticipants 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. | Behavioural | Time of choice exercise |
Primary outcome
Consent rates
Time frame: Pre-intervention
Percent of eligible individuals electing to enroll in the study
Study completion rates
Time frame: At study completion, an average of 14 weeks
Percent of consented individuals completing the post-intervention assessment
Physical activity timing adherence rates
Time frame: 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)
Acceptability questionnaire
Time frame: 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
4 secondary outcomes
Average daily physical activity minutes
Time frame: Through study completion, an average of 14 weeks
Average days per week with at least 15 min of physical activity
Time frame: Through study completion, an average of 14 weeks
Barriers and facilitators of physical activity questionnaire
Time frame: Through study completion, an average of 14 weeks
Preferred physical activity timing questionnaire
Time frame: At study completion, an average of 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Schumacher, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning exercise goal, Evening exercise goal and Time of choice exercise goal in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rates (time frame: Pre-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.