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The purpose of this pilot study is to determine the feasibility and acceptability of randomizing adults with overweight and obesity to an exercise intervention of either prescribed morning aerobic exercise (AM-EX) or prescribed evening aerobic exercise (PM-EX) progressing to 2000 kcal/wk.
The purpose of this pilot study is to determine the feasibility and acceptability of randomizing adults with overweight and obesity to an exercise intervention of either prescribed morning aerobic exercise (AM-EX) or prescribed evening aerobic exercise (PM-EX) progressing to 2000 kcal/wk. Specifically, the purpose of this study is to assess recruitment, retention, and adherence to the exercise interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AM-EX | Experimental | Participants in this group will be prescribed morning aerobic exercise. |
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| PM-EX | Experimental | Participants in this group will be prescribed evening aerobic exercise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AM-EX | Behavioral | AM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 6 and 10 AM. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment (Number of contacts) | Feasibility of recruitment will be evaluated by the number of people who contact study staff expressing interest in the study | End of enrollment (estimated between 6 and 12 months) |
| Feasibility of Recruitment (eligibility rate) | Feasibility of recruitment will be evaluated by calculating the number of volunteers who contact study staff to express interest in participation, the eligibility rate (number eligible divided by total volunteers) | End of enrollment (estimated between 6 and 12 months) |
| Feasibility of Recruitment (enrollment rate) | Feasibility of recruitment will be evaluated by calculating the enrollment rate (number enrolled divided by the number of total volunteers) | End of enrollment (estimated between 6 and 12 months) |
| Adherence to Exercise Intervention (session attendance) | Adherence will be calculated as (number of sessions attended/number of sessions prescribed) | Baseline to 15 weeks (reported at Week 15) |
| Adherence to Exercise Intervention (kcal adherence) | Adherence will be calculated as (number of kcals prescribed/ number of kcals of exercise completed) | Baseline to 15 weeks (reported at Week 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change (kg) | Body weight will be measured at baseline and weeks 4, 8, 12, and 15 using a digital scale accurate to ±0.1 kg | Baseline to 15 weeks |
| Physical Activity Change (min/d) | Physical activity will be measured using the ActivPAL v4 |
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Inclusion Criteria:
Female or Male
Age 18-55 years
Body Mass Index 25-40 kg/m2
Physically inactive: defined as self-reporting <150 minutes per week of physical activity at moderate intensity or greater on a regular basis over the past 3 months.
No self-report of acute or chronic disease (cardiovascular disease (CVD), diabetes, gastrointestinal disorders and orthopedic problems in particular)
No plans to relocate within the next 6 months
No plans for extended travel (> 1weeks) within the next 6 months
No nicotine use
Live or work within 30 minutes of the AHWC (exceptions may be made at the discretion of the Study PI on a case by case basis for highly motivated subjects).
Capable and willing to give informed consent, understand exclusion criteria, accept the randomized group assignment, and complete outcome measures.
Own a smartphone and willing to download and use text messaging for meal intake and other related assessments.
Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions.
For Females
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth A Creasy, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| PM-EX | Behavioral | PM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 3 and 7 PM. |
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| Baseline to 15 weeks |
| Meal Timing Change (clock time of first meal) | Meal timing will be assessed using digital photography paired with a date and time stamp (time of first meal) | Baseline to 15 weeks |
| Meal Timing Change (clock time of last meal) | Meal timing will be assessed using digital photography paired with a date and time stamp (time of last meal) | Baseline to 15 weeks |
| Sleep Timing Change (mid-point of sleep) | Mid-point of sleep will be measured using the Actiwatch 2 (starting sleep time + (sleep duration/2)) | Baseline to 15 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |