ObesityFHSNCT03321305
Eating Frequency and Visceral Adipose Tissue, Body Fat, and Obesity Risk in Hispanic College Freshmen
An observational study of Obesity and Metabolic Disease, run by University of Texas at Austin at 1 site in United States.
Trial summary
Due to the increased focus on education and changing lifestyle, college students are particularly susceptible to poor overall health and wellness due to inadequate sleep and poor dietary choices. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Disease, Eating Behavior
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2013to 1 Nov 2016
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: For the survey portion of this study will be general in that participants must be currently enrolled freshmen students at UT Austin. Students can be male or female and of any ethnicity. Participants must be 18 years of age or older. The In-Person Visit inclusion/exclusion criteria will be more extensive and include the following: Ethnicity: This portion of the study will be limited to self-reported Hispanics because of their high risk of visceral adiposity and metabolic disorders. Eating Frequency We will enroll half Infrequent Eaters (≤2 EOs per day) and half Normal Eaters (≥3 EOs per day). Eating frequency groups will be identified via the previous survey data and verified with 24-hour diet recalls. BMI Status: We will include a natural selection of normal, overweight and obese students based on the Centers for Disease Control growth charts.
Who may be able to join
- Male or female;
- Ages 18-24 years;
- Self-reported Hispanics (all four grandparents must be Hispanic)
- 50% of the sample will be self reported infrequent eaters (those who eat less than 2 eating occasions per day), as measured by 24-hr recalls
- 50% of the sample will be self-reported frequent eaters (those who report 3 or more eating occasions per day)
- A natural selection of normal, overweight and obese subjects will be recruited.
Who cannot join
- Subjects with serious medical disease as identified from a health history form;
- Pregnant;
- Taking any medications known to influence body composition or glucose/insulin action or psychoactive medications;
- Are diagnosed with diseases that may influence glucose/insulin indices or body composition;
- Have participated in a weight loss, dietary, or physical activity intervention in the past 6 months;
- Have a learning impairment that would complicate survey administration;
- Have braces, a pacemaker, or any other contraindications to MRI scanning, as visceral adipose tissue is a primary outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Freshman Health Study
Due to the increased focus on education and changing lifestyle, college students are particularly susceptible to poor overall health and wellness due to inadequate sleep and poor dietary choices. This is particularly important because the behavioral choices college students make may affect their risk of chronic disease. This study will research these topics via an online survey, in person visit and stool sample.
Read the detailed description
It is important for college students to establish healthy habits during college because they are likely to stay with them throughout their lives. The transition to college has been identified as a critical period contributing to the rise in obesity rates. Several studies have shown that the initial transition to college is associated with rapid weight gain and the average weight gain in the first year of college ranges from 3.5 to 8.8 pounds. While decreased dietary fiber, fruits and vegetables and junk food consumption are among the dietary factors that have been linked to increased obesity rates in college students, little is known about the effect of eating patterns on health in this population. Furthermore, lack of sleep, smoking, binge drinking, and infrequent eating are all associated with negative health outcomes. Previous work with college age youth has found that several behaviors cluster together. The goal of the Online Survey portion is to expand on current findings, as well as examine the interrelationships of alcohol use, sleep, smoking, and eating patterns with adiposity and metabolic disease risk in a population of freshmen college students.
Eating frequency research has consistently found a negative association between the number of eating occasions (EOs) per day and adiposity, as well as metabolic disease risk in both youth and adult populations. Our group has shown that infrequent eating is linked to increased obesity measures, blunted insulin action, and deleterious lipid parameters in multiple populations of overweight Hispanic youth (8-18y). However, to date, no group has looked at the effect of eating frequency on adiposity and metabolic disease risk in a sample of overweight Hispanic college freshmen. In 2012, for the first time in history Hispanic high school graduates (69%) were more likely to be enrolled in college than Non-Hispanic Whites (NHW; 67%) and Blacks (63%) and last year Hispanic students represented 24% of freshman enrollment at the University of Texas at Austin (UT), Hispanics also showed the largest increase among all minority groups. Thus, the goal of the In-Person Visit is to examine the relationship between eating frequency and adiposity/metabolic disease risk in this extremely high-risk population of Hispanic freshmen and potentially identify interventions that may reduce this risk within such a crucial period of life.
The human body contains 100 trillion microbes, and microbial genes outnumber human genes 100:110. Over the past decade, interest in the complex ecosystem of gut microbiota has increased immensely and research has uncovered a relationship between gut microbiota, metabolic disease, and obesity. Both diet and obesity have been shown to alter the gut microbiota12,13. However, few studies have investigated how individual dietary components can affect the gut microbiota in humans. The Stool Sample portion of the study is an exploratory investigation of the relationship between dietary components and gut microbiota composition in college-aged Hispanic freshmen.
- Conditions
- Obesity, Metabolic Disease, Eating Behavior, Adiposity, Sleep, Physical Activity
- Medical subject headings
- Obesity, Metabolic Diseases, Feeding Behavior, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
College Students Habits and Obesity Risk
Examine the interrelationships of alcohol use, sleep, smoking, eating patterns, and physical activity with obesity (i.e., BMI parameters as measured by height in meters and weight in kilograms) in a population of freshmen college students
Measured: 2013-2017
College student habits and type 2 diabetes risk factors
Examine the interrelationships of alcohol use, sleep, smoking, eating patterns, and physical activity with type 2 diabetes risk factors (i.e., glucose, insulin, insulin resistance as measured by fasting blood glucose) in a population of freshmen college students
Measured: 2013-2017
College student habits and adiposity
Examine the interrelationship of alcohol use, sleep, smoking,eating patterns, and physical activity on adiposity (i.e., total body fat as measured by BodPod and visceral fat and liver fat as measured by MRI).
Measured: 2013-2017
Secondary outcomes (2)
Stool Samples and Gut Microbiome
Exploratory investigation of the relationship between dietary components and gut microbiota composition (specifically microbial diversity) in college-aged Hispanic freshmen
Measured: 2013-2017
College Habits and Circulating lipids
Examine the interrelationship of alcohol use, sleep, smoking, eating patterns and physical activity levels on lipids (i.e., total cholesterol, triglycerides, and very low-density lipoprotein as measured by fasting blood draw).
Measured: 2013-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start13 Nov 2013
- Primary completion1 Jun 2016
- Study completion1 Nov 2016
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.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaimie N Davis, PhD,RD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321305
- Sponsor's protocol ID
- 2013-11-0017
- Acronym
- FHS
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared. Only aggregate data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freshman Health Study
- ClinicalTrials.gov ID
- NCT03321305
- Acronym / sponsor ID
- FHS / 2013-11-0017
- Conditions
- Obesity, Metabolic Disease, Eating Behavior, Adiposity, Sleep, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 13 Nov 2013 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 25 Oct 2017 (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.
Due to the increased focus on education and changing lifestyle, college students are particularly susceptible to poor overall health and wellness due to inadequate sleep and poor dietary choices. This is particularly important because the behavioral choices college students make may affect their risk of chronic disease. This study will research these topics via an online survey, in person visit and stool sample.
Detailed description
It is important for college students to establish healthy habits during college because they are likely to stay with them throughout their lives. The transition to college has been identified as a critical period contributing to the rise in obesity rates. Several studies have shown that the initial transition to college is associated with rapid weight gain and the average weight gain in the first year of college ranges from 3.5 to 8.8 pounds. While decreased dietary fiber, fruits and vegetables and junk food consumption are among the dietary factors that have been linked to increased obesity rates in college students, little is known about the effect of eating patterns on health in this population. Furthermore, lack of sleep, smoking, binge drinking, and infrequent eating are all associated with negative health outcomes. Previous work with college age youth has found that several behaviors cluster together. The goal of the Online Survey portion is to expand on current findings, as well as examine the interrelationships of alcohol use, sleep, smoking, and eating patterns with adiposity and metabolic disease risk in a population of freshmen college students.
Eating frequency research has consistently found a negative association between the number of eating occasions (EOs) per day and adiposity, as well as metabolic disease risk in both youth and adult populations. Our group has shown that infrequent eating is linked to increased obesity measures, blunted insulin action, and deleterious lipid parameters in multiple populations of overweight Hispanic youth (8-18y). However, to date, no group has looked at the effect of eating frequency on adiposity and metabolic disease risk in a sample of overweight Hispanic college freshmen. In 2012, for the first time in history Hispanic high school graduates (69%) were more likely to be enrolled in college than Non-Hispanic Whites (NHW; 67%) and Blacks (63%) and last year Hispanic students represented 24% of freshman enrollment at the University of Texas at Austin (UT), Hispanics also showed the largest increase among all minority groups. Thus, the goal of the In-Person Visit is to examine the relationship between eating frequency and adiposity/metabolic disease risk in this extremely high-risk population of Hispanic freshmen and potentially identify interventions that may reduce this risk within such a crucial period of life.
The human body contains 100 trillion microbes, and microbial genes outnumber human genes 100:110. Over the past decade, interest in the complex ecosystem of gut microbiota has increased immensely and research has uncovered a relationship between gut microbiota, metabolic disease, and obesity. Both diet and obesity have been shown to alter the gut microbiota12,13. However, few studies have investigated how individual dietary components can affect the gut microbiota in humans. The Stool Sample portion of the study is an exploratory investigation of the relationship between dietary components and gut microbiota composition in college-aged Hispanic freshmen.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- For the survey portion of this study will be general in that participants must be currently enrolled freshmen students at UT Austin. Students can be male or female and of any ethnicity. Participants must be 18 years of age or older. The In-Person Visit inclusion/exclusion criteria will be more extensive and include the following: Ethnicity: This portion of the study will be limited to self-reported Hispanics because of their high risk of visceral adiposity and metabolic disorders. Eating Frequency We will enroll half Infrequent Eaters (≤2 EOs per day) and half Normal Eaters (≥3 EOs per day). Eating frequency groups will be identified via the previous survey data and verified with 24-hour diet recalls. BMI Status: We will include a natural selection of normal, overweight and obese students based on the Centers for Disease Control growth charts.
Key inclusion criteria (6 listed)
- Male or female;
- Ages 18-24 years;
- Self-reported Hispanics (all four grandparents must be Hispanic)
- 50% of the sample will be self reported infrequent eaters (those who eat less than 2 eating occasions per day), as measured by 24-hr recalls
- 50% of the sample will be self-reported frequent eaters (those who report 3 or more eating occasions per day)
Key exclusion criteria (7 listed)
- Subjects with serious medical disease as identified from a health history form;
- Pregnant;
- Taking any medications known to influence body composition or glucose/insulin action or psychoactive medications;
- Are diagnosed with diseases that may influence glucose/insulin indices or body composition;
- Have participated in a weight loss, dietary, or physical activity intervention in the past 6 months;
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
College Students Habits and Obesity Risk
Time frame: 2013-2017
Examine the interrelationships of alcohol use, sleep, smoking, eating patterns, and physical activity with obesity (i.e., BMI parameters as measured by height in meters and weight in kilograms) in a population of freshmen college students
College student habits and type 2 diabetes risk factors
Time frame: 2013-2017
Examine the interrelationships of alcohol use, sleep, smoking, eating patterns, and physical activity with type 2 diabetes risk factors (i.e., glucose, insulin, insulin resistance as measured by fasting blood glucose) in a population of freshmen college students
College student habits and adiposity
Time frame: 2013-2017
Examine the interrelationship of alcohol use, sleep, smoking,eating patterns, and physical activity on adiposity (i.e., total body fat as measured by BodPod and visceral fat and liver fat as measured by MRI).
2 secondary outcomes
Stool Samples and Gut Microbiome
Time frame: 2013-2017
College Habits and Circulating lipids
Time frame: 2013-2017
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 25 Oct 2017.
- Individual participant dataSharing planned: No. No individual data will be shared. Only aggregate data.
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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.
Jaimie N Davis, PhD,RD principal investigator
University of Texas at Austin
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 Metabolic Disease, run by University of Texas at Austin 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 6 inclusion and 7 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 25 Oct 2017. 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?
College Students Habits and Obesity Risk (time frame: 2013-2017). The study lists 3 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 25 Oct 2017.