ObesityNCT01645956
Consistency in Individual Differences in Energy Intake Following Acute Exercise
An observational study of Obesity and Sedentary, run by The Miriam Hospital at 1 site in United States.
Trial summary
The importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen. This study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2014
- Phase
- Observational
- 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
Study population: Relatively sedentary (exercising less than 60 minutes/week over the past 6 months) overweight and obese (BMI: 25.0 to <35.0 kg/m2) women between the ages of 18 and 45.
Who may be able to join
- Age 18-45 years
- BMI between 25.0 and <35.0 kg/m2
- Female
- Sedentary, defined as exercising at a moderate-intensity for less than 60 minutes/week over the past 6 months.
Who cannot join
- Presence of any condition that would limit one's ability from exercising (i.e., orthopedic limitations)
- Recent weight gain or weight loss (± 10 pounds within the past 6 months)
- Currently enrolled in a weight loss program
- History of heart disease or diabetes
- Currently taking any medication that would alter heart rate (e.g., beta blocker) or metabolism
- Women who are pregnant, planning on becoming pregnant in the next 2 months, or those pregnant within the past 6 months
Show all 10Show fewer
- Uncontrolled hypertension (currently taking blood pressure medication or having a resting systolic blood pressure ≥140/90 mmHg
- Get an average of <6 hours of sleep/night
- Does not currently eat breakfast regularly
- Known food allergies to test foods or states a disliking or unwillingness to eat more than 25% of the buffet foods.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
The importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen. This study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also examines whether these responses are consistent over time. Participants in this study will be asked to come to our center on 7 different occasions over a 3-4 month period. The first visit will be an assessment visit where body weight and body composition will be measured, questionnaires will be completed, and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions with visits in each pair separated by 48-96 hours) the procedures will be nearly identical. Upon arrival at our center, participants will consume a meal replacement, complete a series of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be resting and 3 will be exercising). One hour following the exercise/resting session, individuals will be given access to a buffet of food, unaware that their food intake will be monitored. All food will be weighed and measured before and after the eating period and the amount of food consumed after each pair of exercise and resting conditions will be compared to one another. It is hypothesized that the difference in food intake will be consistent across pairs of testing sessions. Findings from this study will help us to better understand the relationship between exercise and food intake and may ultimately lead to future studies that can address the clinically significant question of why some individuals gain weight and others lose weight when engaging in exercise training programs. Findings from this study may also help to develop exercise programs that maximize the beneficial effect of exercise on body weight.
- Keywords
- obesity, exercise, energy intake, physical activity
- Medical subject headings
- Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy intake
Measured: 1 hour post exercise/rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica L Unick, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645956
- Sponsor's protocol ID
- 400012
- Other IDs
- 1R03CA162965-01A1
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2012
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency in Individual Differences in Energy Intake Following Acute Exercise
- ClinicalTrials.gov ID
- NCT01645956
- Acronym / sponsor ID
- 400012
- Keywords
- obesity, exercise, energy intake, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Jul 2012 (estimated)
- 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.
The importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen. This study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also examines whether these responses are consistent over time. Participants in this study will be asked to come to our center on 7 different occasions over a 3-4 month period. The first visit will be an assessment visit where body weight and body composition will be measured, questionnaires will be completed, and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions with visits in each pair separated by 48-96 hours) the procedures will be nearly identical. Upon arrival at our center, participants will consume a meal replacement, complete a series of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be resting and 3 will be exercising). One hour following the exercise/resting session, individuals will be given access to a buffet of food, unaware that their food intake will be monitored. All food will be weighed and measured before and after the eating period and the amount of food consumed after each pair of exercise and resting conditions will be compared to one another. It is hypothesized that the difference in food intake will be consistent across pairs of testing sessions. Findings from this study will help us to better understand the relationship between exercise and food intake and may ultimately lead to future studies that can address the clinically significant question of why some individuals gain weight and others lose weight when engaging in exercise training programs. Findings from this study may also help to develop exercise programs that maximize the beneficial effect of exercise on body weight.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Relatively sedentary (exercising less than 60 minutes/week over the past 6 months) overweight and obese (BMI: 25.0 to <35.0 kg/m2) women between the ages of 18 and 45.
Key inclusion criteria (4 listed)
- Age 18-45 years
- BMI between 25.0 and <35.0 kg/m2
- Female
- Sedentary, defined as exercising at a moderate-intensity for less than 60 minutes/week over the past 6 months.
Key exclusion criteria (10 listed)
- Presence of any condition that would limit one's ability from exercising (i.e., orthopedic limitations)
- Recent weight gain or weight loss (± 10 pounds within the past 6 months)
- Currently enrolled in a weight loss program
- History of heart disease or diabetes
- Currently taking any medication that would alter heart rate (e.g., beta blocker) or metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
energy intake
Time frame: 1 hour post exercise/rest
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 19 Feb 2015.
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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.
Jessica L Unick, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Sedentary, run by The Miriam Hospital 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 4 inclusion and 10 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 19 Feb 2015. 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?
energy intake (time frame: 1 hour post exercise/rest). 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 19 Feb 2015.