ObesityNCT02043457
Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance
An observational study of Obesity, run by University of Michigan at 1 site in United States.
Trial summary
The Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. Read more about this study
- Who is it for?
- Ages 15 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- phenotyping
- Type of treatment
- Pill or oral medicine
- How many people
- 3,200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 3000 obese participating in a 2 year clinical weight loss and weight maintenance program and 200 lean controls may opt-in to participate in a number of evaluations including depression inventory and HRQOL questionnaires, assessing hunger and appetite, work performance (including presenteeism and absenteeism), pain survey, oral glucose tolerance testing, mixed meal tolerance testing with metabolomics, DNA, RNA, with or without muscle and adipose tissue biopsies, body composition by DEXA or BodPod, measurements of REE and V02 max before at baseline, at 10-15% weight loss and after the 2 year clinical program.
Who may be able to join
- Obese males and females: age >20 years; Obese population defined as BMI > or = 27 kg/m2
- Lean population BMI < 27 but > 17 kg/m2
- Able and willing to provide written informed consent for the trial
Who cannot join
- Evidence of inherited disorders of lipid metabolism.
- History of Cancer within the last 5 years
- Human immunodeficiency virus (HIV) antibody positive.
- Patients with solid organ transplants.
- Participation in any other clinical trial within 90 days of entry into this trial.
- Pregnant or lactating females.
Show all 18Show fewer
- Uncontrolled thyroid disease
- Unstable angina or NY heart association class II failure or above
- Gastrointestinal disease specifically GI motility disorders
- Unstable neuropsychiatric disease including major depression/anxiety, eating disorder such as binge eating, bulimia or anorexia
- End stage renal or hepatic disease
- Autoimmune disorders (e.g. SLE)
- Body weight fluctuation of more than 5 kg in the previous 3 months
- Prior bariatric surgery
- A history or current alcohol/substance abuse and change in smoking habits or cessation in the past 6 months.
- Women of childbearing age must use a reliable form of contraception.
- Any medical condition, which in the opinion of the investigator would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol.
- Unwilling or unable to consent for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48106
Amy E Rothberg, MD, PhD, 734-647-5871, arothber@med.umich.edu
Nicole Miller, MPH, RD, 734-232-3587, npiazza@med.umich.edu
About this study
The Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size fits all' philosophy is untenable with a complex disease such as obesity. The clinic will serve as a portal for patients to choose standard clinical care or to explore alternatives from a variety of clinical studies offered through the clinic. These studies will include further investigations into nutrition, the biological basis of weight and weight management and protocols using approved and experimental pharmaceuticals as well as technologies that aid in self-management of weight.
- Conditions
- Obesity
- Being tested
- phenotyping
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenotypingOther
Also called Phentoyping includes:, Health related quality of life questionnaires, Depression Inventory, Work Performance
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Opt-in intervention to include the following procedures, called 'phenotyping' performed at baseline, after 10-15% weight loss from baseline weight or 6 months (whichever comes first) and at end of 2 years while in weight maintenance: oral glucose tolerance test, mixed meal tolerance test, with fasting leptin, biased and unbiased metabolomic profiling, DNA, RNA, muscle and adipose tissue biopsies: measurement of resting energy expenditure by indirect calorimetry; oxidative capacity (V02 peak/max); body composition by Dual Energy X-ray Absorptiometry (DEXA) or air displacement plethysmograph (Bod Pod); inventories of depression and health related quality of life instruments, measures of impulsivity, measures of hunger and appetite, work performance (including presenteeism and absenteeism) and pain survey. Receives: Other: phenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic factors related to weight loss and long-term weight maintenance
Phenotypic factors include:
blood glucose levels, lipomic/metabolomic measurements, genetic analysis, body fat percentage, maximal oxygen consumption, respiratory quotient, resting metabolic rate, physical/emotional health
Measured: Change in phenotypic factors from baseline to 3-6 months and at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startAug 2009
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy E Rothberg, University of Michigan
- Investigators
- Charles Burant, MD, PhD, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043457
- Sponsor's protocol ID
- HUM00030088
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2014
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Rothberg AE, Marriott DJ, Miller NM, Herman WH. Retention and weight outcomes after transitioning an intensive behavioral weight management program from an in-person to a virtual format. Obes Sci Pract. 2023 Apr 20;9(5):452-458. doi: 10.1002/osp4.673. eCollection 2023 Oct.
PubMed 37810529Rothberg AE, McEwen LN, Kraftson AT, Fowler CE, Herman WH. Very-low-energy diet for type 2 diabetes: an underutilized therapy? J Diabetes Complications. 2014 Jul-Aug;28(4):506-10. doi: 10.1016/j.jdiacomp.2014.03.014. Epub 2014 Mar 29.
PubMed 24849710
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance
- ClinicalTrials.gov ID
- NCT02043457
- Acronym / sponsor ID
- HUM00030088
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 Jan 2014 (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 Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size fits all' philosophy is untenable with a complex disease such as obesity. The clinic will serve as a portal for patients to choose standard clinical care or to explore alternatives from a variety of clinical studies offered through the clinic. These studies will include further investigations into nutrition, the biological basis of weight and weight management and protocols using approved and experimental pharmaceuticals as well as technologies that aid in self-management of weight.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | – | Other: phenotypingOpt-in intervention to include the following procedures, called 'phenotyping' performed at baseline, after 10-15% weight loss from baseline weight or 6 months (whichever comes first) and at end of 2 years while in weight maintenance: oral glucose tolerance test, mixed meal tolerance test, with fasting leptin, biased and unbiased metabolomic profiling, DNA, RNA, muscle and adipose tissue biopsies: measurement of resting energy expenditure by indirect calorimetry; oxidative capacity (V02 peak/max); body composition by Dual Energy X-ray Absorptiometry (DEXA) or air displacement plethysmograph (Bod Pod); inventories of depression and health related quality of life instruments, measures of impulsivity, measures of hunger and appetite, work performance (including presenteeism and absenteeism) and pain survey. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 3000 obese participating in a 2 year clinical weight loss and weight maintenance program and 200 lean controls may opt-in to participate in a number of evaluations including depression inventory and HRQOL questionnaires, assessing hunger and appetite, work performance (including presenteeism and absenteeism), pain survey, oral glucose tolerance testing, mixed meal tolerance testing with metabolomics, DNA, RNA, with or without muscle and adipose tissue biopsies, body composition by DEXA or BodPod, measurements of REE and V02 max before at baseline, at 10-15% weight loss and after the 2 year clinical program.
Key inclusion criteria (3 listed)
- Obese males and females: age >20 years; Obese population defined as BMI > or = 27 kg/m2
- Lean population BMI < 27 but > 17 kg/m2
- Able and willing to provide written informed consent for the trial
Key exclusion criteria (18 listed)
- Evidence of inherited disorders of lipid metabolism.
- History of Cancer within the last 5 years
- Human immunodeficiency virus (HIV) antibody positive.
- Patients with solid organ transplants.
- Participation in any other clinical trial within 90 days of entry into this trial.
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 |
|---|---|---|
| phenotypingAlso: Phentoyping includes:, Health related quality of life questionnaires, Depression Inventory, Work Performance | Other | Lifestyle intervention |
Primary outcome
Phenotypic factors related to weight loss and long-term weight maintenance
Time frame: Change in phenotypic factors from baseline to 3-6 months and at 2 years
Phenotypic factors include: blood glucose levels, lipomic/metabolomic measurements, genetic analysis, body fat percentage, maximal oxygen consumption, respiratory quotient, resting metabolic rate, physical/emotional health
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 37810529Rothberg AE, Marriott DJ, Miller NM, Herman WH. Retention and weight outcomes after transitioning an intensive behavioral weight management program from an in-person to a virtual format. Obes Sci Pract. 2023 Apr 20;9(5):452-458. doi: 10.1002/osp4.673. eCollection 2023 Oct.
- Derived from this study: PubMed 24849710Rothberg AE, McEwen LN, Kraftson AT, Fowler CE, Herman WH. Very-low-energy diet for type 2 diabetes: an underutilized therapy? J Diabetes Complications. 2014 Jul-Aug;28(4):506-10. doi: 10.1016/j.jdiacomp.2014.03.014. Epub 2014 Mar 29.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Charles Burant, MD, PhD study director
University of Michigan
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, run by University of Michigan 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 3 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy E Rothberg, MD, PhD (734-647-5871, arothber@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypic factors related to weight loss and long-term weight maintenance (time frame: Change in phenotypic factors from baseline to 3-6 months and at 2 years). 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 NCT02043457, which also lists 2 linked publications.
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 13 Jul 2026.