Energy ExpenditureNCT02544009
Quantifying the Persistence of Metabolic Adaptation and Weight Regain Following Extreme Weight Loss
An observational study of Energy Expenditure, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Many people regain the weight they lose through diet and exercise. This might happen because the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may cause people to regain weight if they do not keep up high levels of exercise or major caloric restrictions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Energy Expenditure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2015to 19 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This natural history study includes enrollment of 16 adult subjects who previously participated in the Biggest Loser intervention and participated in a study of body composition and metabolic changes [1]. Several years following weight loss intervention, these subjects may have experienced weight regain and either persistence or remission of the previously observed metabolic adaptation. The present study was designed to investigate the persistence of metabolic adaptation and explore whether the degree of metabolic adaptation during the weight loss intervention was correlated with body weight and body fat regain.
Who may be able to join
- 16 subjects who previously participated in the Biggest Loser study (Pennington Biomedical Research Center protocol no. PBRC29008).
- Written informed consent
Who cannot join
- Volunteers unwilling or unable to give informed consent.
- Women who are pregnant or breastfeeding cannot participate in the study. A pregnancy test will be performed during the first day of the inpatient visit. If the pregnancy test is positive, the subject cannot continue to participate in the study.
- Subjects with implantable cardio-defibrillator or pacemaker may not participate in the bioelectric impedance spectroscopy (BIS) testing portion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Quantifying Weight Regain and the Persistence of Metabolic Adaptation Following Extreme Weight Loss
Background:
Many people regain the weight they lose through diet and exercise. This might happen because the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may cause people to regain weight if they do not keep up high levels of exercise or major caloric restrictions. Researchers want to find the long-term effects of metabolic adaptation in the previous Biggest Loser study participants. They hope to learn the body s response to lifestyle changes that result in weight loss. They also want to see if certain changes can lead to longer-term success in maintaining weight loss.
Read more
Objectives:
To better understand the long-term metabolic changes caused by rapid weight loss achieved through diet restriction and vigorous physical activity.
Eligibility:
Former Biggest Loser research study participants (Protocol No. PBRC29008).
Design:
Participants will be screened with a phone interview.
This study has 3 phases.
Phase 1 will last at least 3 weeks. Participants will receive a physical activity monitor and wireless scale. These will send their daily weight and activity back to NIH.
In Phase 2, participants will stay at NIH for 3 days. Their metabolism will be measured through:
Their activity monitor
Urine samples and daily body weight
Medical review and physical exam
Fasting for 12 hours each night for a blood draw the following morning
DEXA: a low-dose x-ray of the body
BIS: Electrodes on the hand/wrist and foot/ankle measure body water content.
Phase 3 will last at least 3 weeks. Participants will:
Continue to monitor their daily weight and activity
Collect urine samples and send them back to NIH
Read the detailed description
Weight loss is accompanied by a slowing of metabolic rate. Metabolic slowing often occurs to a degree greater than predicted by the amount of weight lost, a phenomenon called metabolic adaptation , and is hypothesized to persist over time and promote weight regain. We previously discovered large metabolic adaptations in response to the intensive lifestyle intervention as part of The Biggest Loser weight loss competition. Those subjects rapidly lost massive amounts of weight and their resting energy expenditure decreased by ~500 kcal/d more than was expected based on their body composition at the end of the intervention. The purpose of this study is to investigate whether the metabolic adaptation has persisted in the years following the intervention in the same subjects. Furthermore, we will measure body weight and composition in these subjects and investigate the correlates of weight regain.
- Conditions
- Energy Expenditure
- Keywords
- Energy Expenditure, Obesity, Behavioral Weight Loss Treatment, Natural History
- Medical subject headings
- Obesity
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 |
|---|---|---|
| 1 | 16 subjects who previously participated in the Biggest Loser study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure body composition and REE several years after completion of The Biggest Loser intervention. Metabolic adaptation will be calculated as the difference between the measured REE and the REE predicted from linear regression analysis of baseli...
The primary analysis will use a t-test to test the null hypothesis that this difference is equal to zero. Secondary analyses will explore predictors of metabolic adaptation.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start5 Sep 2015
- Primary completion19 May 2016
- Study completion19 May 2016
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 Energy ExpenditureStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin Hall, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544009
- Sponsor's protocol ID
- 150192
- Other IDs
- 15-DK-0192
- Status last verified
- Apr 2025
- First submitted
- 5 Sep 2015
- Last updated
- 22 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kerns JC, Guo J, Fothergill E, Howard L, Knuth ND, Brychta R, Chen KY, Skarulis MC, Walter PJ, Hall KD. Increased Physical Activity Associated with Less Weight Regain Six Years After "The Biggest Loser" Competition. Obesity (Silver Spring). 2017 Nov;25(11):1838-1843. doi: 10.1002/oby.21986.
PubMed 29086499Fothergill E, Guo J, Howard L, Kerns JC, Knuth ND, Brychta R, Chen KY, Skarulis MC, Walter M, Walter PJ, Hall KD. Persistent metabolic adaptation 6 years after "The Biggest Loser" competition. Obesity (Silver Spring). 2016 Aug;24(8):1612-9. doi: 10.1002/oby.21538. Epub 2016 May 2.
PubMed 27136388
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Weight Regain and the Persistence of Metabolic Adaptation Following Extreme Weight Loss
- ClinicalTrials.gov ID
- NCT02544009
- Acronym / sponsor ID
- 150192
- Conditions
- Energy Expenditure
- Keywords
- Energy Expenditure, Obesity, Behavioral Weight Loss Treatment, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 5 Sep 2015
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 9 Sep 2015 (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.
Background:
Many people regain the weight they lose through diet and exercise. This might happen because the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may cause people to regain weight if they do not keep up high levels of exercise or major caloric restrictions. Researchers want to find the long-term effects of metabolic adaptation in the previous Biggest Loser study participants. They hope to learn the body s response to lifestyle changes that result in weight loss. They also want to see if certain changes can lead to longer-term success in maintaining weight loss.
Objectives:
To better understand the long-term metabolic changes caused by rapid weight loss achieved through diet restriction and vigorous physical activity.
Eligibility:
Former Biggest Loser research study participants (Protocol No. PBRC29008).
Design:
Participants will be screened with a phone interview.
This study has 3 phases.
Phase 1 will last at least 3 weeks. Participants will receive a physical activity monitor and wireless scale. These will send their daily weight and activity back to NIH.
In Phase 2, participants will stay at NIH for 3 days. Their metabolism will be measured through:
Their activity monitor
Urine samples and daily body weight
Medical review and physical exam
Fasting for 12 hours each night for a blood draw the following morning
DEXA: a low-dose x-ray of the body
BIS: Electrodes on the hand/wrist and foot/ankle measure body water content.
Phase 3 will last at least 3 weeks. Participants will:
Continue to monitor their daily weight and activity
Collect urine samples and send them back to NIH
Detailed description
Weight loss is accompanied by a slowing of metabolic rate. Metabolic slowing often occurs to a degree greater than predicted by the amount of weight lost, a phenomenon called metabolic adaptation , and is hypothesized to persist over time and promote weight regain. We previously discovered large metabolic adaptations in response to the intensive lifestyle intervention as part of The Biggest Loser weight loss competition. Those subjects rapidly lost massive amounts of weight and their resting energy expenditure decreased by ~500 kcal/d more than was expected based on their body composition at the end of the intervention. The purpose of this study is to investigate whether the metabolic adaptation has persisted in the years following the intervention in the same subjects. Furthermore, we will measure body weight and composition in these subjects and investigate the correlates of weight regain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –16 subjects who previously participated in the Biggest Loser study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This natural history study includes enrollment of 16 adult subjects who previously participated in the Biggest Loser intervention and participated in a study of body composition and metabolic changes [1]. Several years following weight loss intervention, these subjects may have experienced weight regain and either persistence or remission of the previously observed metabolic adaptation. The present study was designed to investigate the persistence of metabolic adaptation and explore whether the degree of metabolic adaptation during the weight loss intervention was correlated with body weight and body fat regain.
Key inclusion criteria (2 listed)
- 16 subjects who previously participated in the Biggest Loser study (Pennington Biomedical Research Center protocol no. PBRC29008).
- Written informed consent
Key exclusion criteria (3 listed)
- Volunteers unwilling or unable to give informed consent.
- Women who are pregnant or breastfeeding cannot participate in the study. A pregnancy test will be performed during the first day of the inpatient visit. If the pregnancy test is positive, the subject cannot continue to participate in the study.
- Subjects with implantable cardio-defibrillator or pacemaker may not participate in the bioelectric impedance spectroscopy (BIS) testing portion of the study.
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
Measure body composition and REE several years after completion of The Biggest Loser intervention. Metabolic adaptation will be calculated as the difference between the measured REE and the REE predicted from linear regression analysis of baseli...
Time frame: 2 weeks
The primary analysis will use a t-test to test the null hypothesis that this difference is equal to zero. Secondary analyses will explore predictors of metabolic adaptation.
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 22 Apr 2025.
- Derived from this study: PubMed 29086499Kerns JC, Guo J, Fothergill E, Howard L, Knuth ND, Brychta R, Chen KY, Skarulis MC, Walter PJ, Hall KD. Increased Physical Activity Associated with Less Weight Regain Six Years After "The Biggest Loser" Competition. Obesity (Silver Spring). 2017 Nov;25(11):1838-1843. doi: 10.1002/oby.21986.
- Derived from this study: PubMed 27136388Fothergill E, Guo J, Howard L, Kerns JC, Knuth ND, Brychta R, Chen KY, Skarulis MC, Walter M, Walter PJ, Hall KD. Persistent metabolic adaptation 6 years after "The Biggest Loser" competition. Obesity (Silver Spring). 2016 Aug;24(8):1612-9. doi: 10.1002/oby.21538. Epub 2016 May 2.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Kevin Hall, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Energy Expenditure, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 2 inclusion and 3 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 22 Apr 2025. 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?
Measure body composition and REE several years after completion of The Biggest Loser intervention. Metabolic adaptation will be calculated as the difference between the measured REE and the REE predicted from linear regression analysis of baseli... (time frame: 2 weeks). 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 NCT02544009, 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 22 Apr 2025.