ObesityNCT03155880
Obesity Heterogeneity Study
An observational study of Obesity, run by Unity Health Toronto.
Trial summary
The investigators will assess the heterogeneity of obese individuals in the United States to help researchers, clinicians and policymakers to establish goals for obesity treatment and identify whether differing interventions may be needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- How many people
- 1,685 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The analyses presented in this report included obese adult participants >=20 years of age, giving a sample size of 1,873 (90% of obese participants). Due to missing data in the covariates, the final analytical sample size was 1,685 (90 % of intended sample).
Who may be able to join
- All
Who cannot join
- Pregnant
About this study
Official title: National Health and Nutrition Examination Survey (NHANES), Obesity Heterogeneity Study
The investigators will assess the heterogeneity of obese individuals in the United States to help researchers, clinicians and policymakers to establish goals for obesity treatment and identify whether differing interventions may be needed.
Read the detailed description
Guidelines for obesity set common targets for interventions and goals around weight loss, and randomized trials and epidemiologic studies of obesity tend to consider obesity to be a homogeneous entity . The investigators will analyze data from the 2011-2012 wave of the NHANES. Obesity will be defined as having a body mass index greater than or equal to 30 Kg/m2. The investigators aim to identify obese sub-groups according to demographic factors, clinical conditions and behavioral characteristics. Results of this type of analysis will shed light on an important gap in the way that obesity interventions and guidelines are developed and will be an important step in beginning the discussion towards this important area.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity
: NHANES collects objective physical examination data for each respondent in the sample, in mobile examination centers for standardization purposes. Body Mass Index (BMI) was calculated as weight in kilograms divided by height in meters squared, and then rounded to one decimal place. Participants were classified as obese using World Health Organization cut-offs for BMI (i.e. ≥30 kg/m2).
Measured: One day. The body measures data were collected, in the Mobile Examination Center (MEC), by trained health technicians.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
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 Unity Health TorontoThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,685 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155880
- Sponsor's protocol ID
- 000001
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 18 May 2017
- 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 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Health and Nutrition Examination Survey (NHANES), Obesity Heterogeneity Study
- ClinicalTrials.gov ID
- NCT03155880
- Acronym / sponsor ID
- 000001
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,685 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 May 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.
The investigators will assess the heterogeneity of obese individuals in the United States to help researchers, clinicians and policymakers to establish goals for obesity treatment and identify whether differing interventions may be needed.
Detailed description
Guidelines for obesity set common targets for interventions and goals around weight loss, and randomized trials and epidemiologic studies of obesity tend to consider obesity to be a homogeneous entity . The investigators will analyze data from the 2011-2012 wave of the NHANES. Obesity will be defined as having a body mass index greater than or equal to 30 Kg/m2. The investigators aim to identify obese sub-groups according to demographic factors, clinical conditions and behavioral characteristics. Results of this type of analysis will shed light on an important gap in the way that obesity interventions and guidelines are developed and will be an important step in beginning the discussion towards this important area.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The analyses presented in this report included obese adult participants >=20 years of age, giving a sample size of 1,873 (90% of obese participants). Due to missing data in the covariates, the final analytical sample size was 1,685 (90 % of intended sample).
Key inclusion criteria (1 listed)
- All
Key exclusion criteria (1 listed)
- Pregnant
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
Obesity
Time frame: One day. The body measures data were collected, in the Mobile Examination Center (MEC), by trained health technicians.
: NHANES collects objective physical examination data for each respondent in the sample, in mobile examination centers for standardization purposes. Body Mass Index (BMI) was calculated as weight in kilograms divided by height in meters squared, and then rounded to one decimal place. Participants were classified as obese using World Health Organization cut-offs for BMI (i.e. ≥30 kg/m2).
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 May 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Unity Health Toronto.
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 1 inclusion and 1 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Obesity (time frame: One day. The body measures data were collected, in the Mobile Examination Center (MEC), by trained health technicians.). 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 May 2017.