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Overweight and ObesityTIC-TOCNCT04262115

Morning Versus Evening Exercise for Adults With Overweight and Obesity

A study testing AM-EX and PM-EX in people with Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 56 years
Conditions the study is for
Overweight and Obesity
What is being tested?
AM-EX and PM-EX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
6 Feb 2020to 1 Jul 2021
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 18 to 56 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.
  • Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease.
  • Significant pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.
  • Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
  • Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, sleep, or energy metabolism (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants)
  • Regular use of systemic steroids (other than Oral Contraceptive Pills).
  • Regular use of obesity pharmacotherapeutic agents within the last 6 months.
  • Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening.
  • Current alcohol or substance abuse
  • Irregular sleep/wake patterns that may hinder ability to consistently exercise at a certain time of day (e.g. night shift-work, swing shifts, etc)
  • Currently dieting or planning to alter diet during the exercise intervention
  • Nicotine use (past 6 months)
  • History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Pattern of response on the QEWP-5 suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
  • Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on BDI will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
  • History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary or exercise interventions.
  • Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials.
  • Weight loss >5% in past 3 months for any reason except post-partum weight loss, weight gain >% in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study.
  • Weight loss of >50 lbs in past 3 years for any reason except post-partum weight loss.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Feasibility and Acceptability of Morning Versus Evening Exercise for Adults With Overweight and Obesity: A Randomized Pilot Study

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.

Read the 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.

Being tested
AM-EX, PM-EX
Keywords
exercise, physical activity, weight loss
Medical subject headings
Overweight, Obesity, Motor Activity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AM-EXBehavioural

    AM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 6 and 10 AM.

  • PM-EXBehavioural

    PM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 3 and 7 PM.

Study groups in NCT04262115
Study groupRoleWhat they receive
AM-EXExperimentalParticipants in this group will be prescribed morning aerobic exercise.
Receives: Behavioral: AM-EX
PM-EXExperimentalParticipants in this group will be prescribed evening aerobic exercise.
Receives: Behavioral: PM-EX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: End of enrollment (estimated between 6 and 12 months)

  2. 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)

    Measured: End of enrollment (estimated between 6 and 12 months)

  3. 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)

    Measured: End of enrollment (estimated between 6 and 12 months)

  4. Adherence to Exercise Intervention (session attendance)

    Adherence will be calculated as (number of sessions attended/number of sessions prescribed)

    Measured: Baseline to 15 weeks (reported at Week 15)

  5. Adherence to Exercise Intervention (kcal adherence)

    Adherence will be calculated as (number of kcals prescribed/ number of kcals of exercise completed)

    Measured: Baseline to 15 weeks (reported at Week 15)

Secondary outcomes (5)

  1. 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

    Measured: Baseline to 15 weeks

  2. Physical Activity Change (min/d)

    Physical activity will be measured using the ActivPAL v4

    Measured: Baseline to 15 weeks

  3. 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)

    Measured: Baseline to 15 weeks

  4. 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)

    Measured: Baseline to 15 weeks

  5. Sleep Timing Change (mid-point of sleep)

    Mid-point of sleep will be measured using the Actiwatch 2 (starting sleep time + (sleep duration/2))

    Measured: Baseline to 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start6 Feb 2020
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04262115
Sponsor's protocol ID
19-2676
Acronym
TIC-TOC
Status last verified
Oct 2021
First submitted
6 Feb 2020
Last updated
12 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AM-EX and PM-EX in people with Overweight and Obesity, run by University of Colorado, Denver 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 16 inclusion and 26 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: finished, as of the sponsor's last update on 12 Oct 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility of Recruitment (Number of contacts) (time frame: End of enrollment (estimated between 6 and 12 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04262115.

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 12 Oct 2021.

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