Morning Versus Evening Exercise for Adults With Overweight and Obesity

NCT04262115 | Completed

• 1 other identifier: 19-2676
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

exercise; physical activity; weight loss

Outcome Measures

Primary Outcomes (5)

• 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)

Secondary Outcomes (5)

• Weight Change (kg)

  Baseline to 15 weeks

• Physical Activity Change (min/d)

  Baseline to 15 weeks

• Meal Timing Change (clock time of first meal)

  Baseline to 15 weeks

• Meal Timing Change (clock time of last meal)

  Baseline to 15 weeks

• Sleep Timing Change (mid-point of sleep)

  Baseline to 15 weeks

Study Arms (2)

AM-EX

EXPERIMENTAL

Participants in this group will be prescribed morning aerobic exercise.

Behavioral: AM-EX

PM-EX

EXPERIMENTAL

Participants in this group will be prescribed evening aerobic exercise.

Behavioral: PM-EX

Interventions

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.

AM-EX

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.

PM-EX

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Diastolic blood pressure \> 100 mm HG or systolic blood pressure \> 160 mm HG.
• Resting heart rate \>100
• Diabetes (fasting glucose ≥126 mg/dL or Hemoglobin A1C ≥6.5%)
• Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.
• Hematocrit, white blood cell count or platelets significantly outside the normal reference range.
• Triglycerides \> 400 mg/dL
• LDL cholesterol \>200 mg/dL
• Abnormal resting electrocardiogram (ECG): serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects.
• Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to optimally participate in the exercise component including: CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection, significant gastrointestinal disorders (described below), significant pulmonary disorders (described below), significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Seth A Creasy, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: February 6, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)