Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing

NCT05073042 | Unknown

• 1 other identifier: 20-01292
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

physical activity; exercise

Outcome Measures

Primary Outcomes (4)

• Consent rates

  Percent of eligible individuals electing to enroll in the study

  Pre-intervention

• Study completion rates

  Percent of consented individuals completing the post-intervention assessment

  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)

  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

  At study completion, an average of 14 weeks

Secondary Outcomes (4)

• Average daily physical activity minutes

  Through study completion, an average of 14 weeks

• Average days per week with at least 15 min of physical activity

  Through study completion, an average of 14 weeks

• Barriers and facilitators of physical activity questionnaire

  Through study completion, an average of 14 weeks

• Preferred physical activity timing questionnaire

  At study completion, an average of 14 weeks

Study Arms (4)

Morning exercise

EXPERIMENTAL

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

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.

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.

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.

Interventions

Morning exercise goal BEHAVIORAL

Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 AM and 10 AM each day.

Morning exercise

Evening exercise goal BEHAVIORAL

Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 PM and 10 PM each day.

Evening exercise

Time of choice exercise goal BEHAVIORAL

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.

Time of choice exercise

Eligibility Criteria

• Age: 35 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Leah Schumacher, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 11, 2021
• Study Start: October 6, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-08

Locations

US (1)