Overweight and Obesity
Conditions
Keywords
exercise, physical activity, weight loss
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAM-EX
AM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 6 and 10 AM.
BEHAVIORALPM-EX
PM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 3 and 7 PM.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 56 Years
Healthy volunteers
No
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 * Not currently pregnant or lactating * Not pregnant within the past 6 months * Not planning to become pregnant in the next 6 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Exercise Intervention (kcal adherence) | Baseline to 15 weeks (reported at Week 15) | Adherence will be calculated as (number of kcals prescribed/ number of kcals of exercise completed) |
| Feasibility of Recruitment (Number of contacts) | End of enrollment (estimated between 6 and 12 months) | Feasibility of recruitment will be evaluated by the number of people who contact study staff expressing interest in the study |
| Feasibility of Recruitment (eligibility rate) | End of enrollment (estimated between 6 and 12 months) | 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) |
| Feasibility of Recruitment (enrollment rate) | End of enrollment (estimated between 6 and 12 months) | Feasibility of recruitment will be evaluated by calculating the enrollment rate (number enrolled divided by the number of total volunteers) |
| Adherence to Exercise Intervention (session attendance) | Baseline to 15 weeks (reported at Week 15) | Adherence will be calculated as (number of sessions attended/number of sessions prescribed) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change (kg) | Baseline to 15 weeks | Body weight will be measured at baseline and weeks 4, 8, 12, and 15 using a digital scale accurate to ±0.1 kg |
| Physical Activity Change (min/d) | Baseline to 15 weeks | Physical activity will be measured using the ActivPAL v4 |
| Meal Timing Change (clock time of first meal) | Baseline to 15 weeks | Meal timing will be assessed using digital photography paired with a date and time stamp (time of first meal) |
| Meal Timing Change (clock time of last meal) | Baseline to 15 weeks | Meal timing will be assessed using digital photography paired with a date and time stamp (time of last meal) |
| Sleep Timing Change (mid-point of sleep) | Baseline to 15 weeks | Mid-point of sleep will be measured using the Actiwatch 2 (starting sleep time + (sleep duration/2)) |
Countries
United States
Outcome results
None listed