Overweight and ObesityNCT04437550
Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females
A study testing Exercise in people with Overweight and Obesity, run by Ohio University at 1 site in United States.
Trial summary
Interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. The benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Aug 2016
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Adult
- apparently healthy
- overweight or class I obese
- eumenorrheic
Who cannot join
- Diabetes
- pregnancy
- cardiovascular disease
- greater than 1 hour of structured physical activity per week
- thyroid disease
- polycystic ovary disease
Trial locations and contacts
1 site in 1 country.
About this study
Interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. The benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance exercise. However how this type of exercise affects appetite and energy intake, particularly in overweight and obese females is not well known.
This study involves two trials of exercise, one at high intensity and one at low intensity, followed by a buffet lunch, in overweight and obese females.
- Conditions
- Overweight and Obesity
- Being tested
- Exercise
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max
| Study group | Role | What they receive |
|---|---|---|
| high-intensity | Experimental | Not described Receives: Other: Exercise |
| low-intensity | Experimental | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy expenditure
caloric expenditure measured via indirect calorimetry
Measured: immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise.
Change in energy intake
measured via standardized lunch
Measured: immediately post exercise
Change in appetite
measured via circulating hormones leptin and acylated ghrelin
Measured: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise and immediately pre-lunch
Change in subjective hunger
via visual analogue scale 100 mm, higher scores indicate greater hunger
Measured: baseline, immediately pre-exercise, immediately post-exercise, immediately pre-lunch, and immediately post-lunch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study startJan 2016
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Marywood University
- Responsible party
- Principal investigator, Angela Hillman, Marywood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437550
- Sponsor's protocol ID
- 801776
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females
- ClinicalTrials.gov ID
- NCT04437550
- Acronym / sponsor ID
- 801776
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Marywood University
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. The benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance exercise. However how this type of exercise affects appetite and energy intake, particularly in overweight and obese females is not well known.
This study involves two trials of exercise, one at high intensity and one at low intensity, followed by a buffet lunch, in overweight and obese females.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity | Experimental | Other: Exercise |
| low-intensity | Experimental | Other: Exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Adult
- apparently healthy
- overweight or class I obese
- eumenorrheic
Key exclusion criteria (6 listed)
- Diabetes
- pregnancy
- cardiovascular disease
- greater than 1 hour of structured physical activity per week
- thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisehigh intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max | Other | high-intensity, low-intensity |
Primary outcome
Change in energy expenditure
Time frame: immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise.
caloric expenditure measured via indirect calorimetry
Change in energy intake
Time frame: immediately post exercise
measured via standardized lunch
Change in appetite
Time frame: immediately pre-breakfast, immediately post-breakfast, immediately post-exercise and immediately pre-lunch
measured via circulating hormones leptin and acylated ghrelin
Change in subjective hunger
Time frame: baseline, immediately pre-exercise, immediately post-exercise, immediately pre-lunch, and immediately post-lunch
via visual analogue scale 100 mm, higher scores indicate greater hunger
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Overweight and Obesity, run by Ohio University 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 5 inclusion and 6 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 18 Jun 2020. 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?
Change in energy expenditure (time frame: immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2020.