ObesityNCT03422380
Energy Expenditure and Weight Loss Maintenance
An observational study of Obesity and Weight Change, Body, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Obesity is reaching epidemic proportions and threatens both health and quality of life of people around the world. While many individuals succeed at short term weight loss, weight loss maintenance is the greatest barrier to successful treatment of obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Weight Change, Body, Weight Loss
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 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 to 65 years
- All sexes
- Adult, Older adult
Study population: The proposed study design is aimed at collecting additional data on previously enrolled adult study subjects in the NWCR, which does not include children. The NWCR contains approximately 70% women and 30% men. We anticipate studying equal numbers of men and women in this study. Minorities comprise approximately 7% of total subjects in the NWCR. In the proposed studies, there will be no exclusions for racial or ethnic background.
Who may be able to join
- Men or women
- Age 18-65
- Weight stable (<10 lb fluctuation in body weight over previous 6 months) or
- NWCR subjects successful at weight loss maintenance (maintaining a loss of ≥ 30 pounds for at least 2 years)
- Non-Reduced Weight Matched Controls: Individuals matched to NWCR subjects' current body weight. These individuals will be normal weight (BMI 18-25, BMI up to 27 allowed in men with waist circumference < 40 cm), and have no history of overweight or obesity (BMI >25) and will not be maintaining a weight loss ≥ 30 pounds.
- Non-Reduced Obese Controls: Individuals matched to NWCR subjects' maximum pre-weight loss body weight. These individuals will be overweight or obese (BMI ≥ 26-45).
Who cannot join
- Diabetes
- Uncontrolled HTN (>160/100)
- History of cardiac disease: CHF or angina, atrial fibrillation or ventricular tachycardia, or significant abnormality on resting EKG
- Symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, dizziness, syncope.
- History of neurological disease: stroke, TIA or seizure disorder
- Current treatment for cancer (except skin)
Show all 20Show fewer
- Severe pulmonary, liver or kidney disease
- Untreated thyroid disorder
- Severe arthritis or other musculoskeletal disorder
- Alcohol or drug abuse
- Active psychiatric illness
- Positive response to PAR-Q indicating requirement for monitored physical activity
- Other serious medical condition as determined by the investigator which would limit physical activity or require monitored activity.
- Pregnant and lactating women, and women actively trying to become pregnant (post-menopausal women on a stable dose of HRT and pre-menopausal women on a stable OCP regimen will be allowed to participate)
- Smoking within the past 6 months
- Subjects using prescription or over the counter medication which may affect RMR including beta blockers, stimulants such as Ritalin and appetite suppressants.
- Subjects who have undergone bariatric surgery or who are currently maintaining their weight loss with prescription weight loss drugs or supplements.
- Severe claustrophobia
- Moderate or high levels of physical activity at the workplace and unable to reduce workplace activity, work from home or take time off from work to participate in Study 2.
- We will exclude controls if they are weight reduced (maintaining a weight loss of ≥ 30 pounds).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Energy Expenditure in Subjects Successful at Weight Loss Maintenance
Obesity is reaching epidemic proportions and threatens both health and quality of life of people around the world. While many individuals succeed at short term weight loss, weight loss maintenance is the greatest barrier to successful treatment of obesity. High levels of physical activity are consistently associated with success in weight loss maintenance. The major goal of this proposal is to understand how and why high levels of physical activity are critical for long term maintenance of weight loss. This project takes advantage of the National Weight Control Registry (NWCR), which follows over 6000 individuals who have maintained a weight loss of ≥30 pounds for ≥1 year. Understanding how individuals successful at weight loss maintenance achieve energy balance will provide important insight into strategies to help more people sustain a weight loss.
Read the detailed description
Participants were recruited in three groups: weight loss maintainers (WLM: maintaining ≥13.6 kg weight loss for ≥1 year), normal weight controls (NC: Body Mass Index (BMI) matched to current BMI of WLM), and controls with overweight/obesity (Overweight Controls (OC): BMI matched to pre-weight loss maximum BMI of WLM). The investigators hypothesize that total daily energy expenditure (TDEE) in WLM is similar to OC but is significantly higher then NC. High levels of volitional physical activity may compensate for the reduction in energy expenditure ("energy gap") that is the expected result of weight loss. This allows WLM to maintain a high level of "energy flux", which may facilitate optimal body weight regulation over time. The investigators will use doubly labeled water to compare TDEE in WLM and both NC and OC. The investigators will also compare individual components of TDEE including resting energy expenditure (REE), thermic effect of food (TEF), physical activity energy expenditure (PAEE), and physical activity level (PAL) between groups. The investigators also hypothesize that REE in WLM is similar to controls of both types under free living conditions, but will decrease following a period of physical inactivity and be significantly less than controls. Studies in rodents have consistently shown evidence of an increase in metabolic efficiency in the reduced obese state manifested by a lower than predicted REE. Studies in humans have shown mixed results, however few studies have controlled for habitual level of physical activity. Recent evidence suggests REE is greater in adults who perform regular exercise than their sedentary peers; this difference can be attributed in part to greater tonic sympathetic nervous system stimulation of REE that occurs in habitually exercising adults. The investigators believe there is an increase in metabolic efficiency in the reduced obese state manifested by a lower than predicted REE, and that high levels of physical activity function to "mask" or "correct" this metabolic efficiency. The investigators will compare REE under free living conditions and during an experimentally imposed period of reduced energy flux (restricted physical activity matched by an equivalent reduction in energy intake) in WLM and controls.
- Conditions
- Obesity, Weight Change, Body, Weight Loss, Physical Activity
- Keywords
- energy expenditure, adaptive thermogenesis, metabolic adaptation, weight loss maintenance
- Medical subject headings
- Obesity, Body Weight Changes, Weight Loss, 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 |
|---|---|---|
| Weight Loss Maintainers (WLM) | Individuals maintaining ≥13.6 kg (30 lb) weight loss for ≥1 year | |
| Normal Weight Controls (NC) | Individuals with normal weight whose BMI was matched to the current BMI of the WLM. NC had to be weight stable and not maintaining a weight loss of ≥13.6kg | |
| Controls with Overweight/Obesity (OC) | Individuals with overweight/obesity whose BMI was matched to the pre-weight loss maximum BMI of WLM. OC had to be weight stable and not maintaining a weight loss of ≥13.6kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Daily Energy Expenditure (TDEE)
After a 12-hour overnight fast, participants provided a baseline urine sample on day 1. Participants were then administered an oral dose of doubly labeled water (DLW) containing 1.8g 10% 18O/kg total body water (TBW) and 0.12 g/kg TBW of 99.9% deuterium. TBW was estimated as 73% of FFM from DXA. The dosing cup was rinsed twice with 30 mL of water and the rinsing dose consumed. Exact time of dosing was recorded. Additional urine samples were collected after a 4hr and 5hr post-dose equilibrium period and then again at the same times on day 8. TDEE over days 1-8 was determined using a single DLW dose and the two-point method according to Schoeller and colleagues.
Measured: At 8 days
Secondary outcomes (4)
Physical Activity Energy Expenditure (PAEE)
PAEE was calculated as TDEE - TEF - REE. In addition, because the energy cost of PA is proportional to body weight for a given intensity and duration, PAEE was also calculated as relative to body weight (kg).
Measured: At 8 days
Resting Energy Expenditure (REE)
REE was measured using standard indirect calorimetry (Truemax 2400, ParvoMedics, Salt Lake City, UT) with the ventilated hood technique. Study participants arrived at 7am after a 12-hour overnight fast. Participants rested supine, awake, and lightly clothed in a thermoneutral (68-74 ˚F), dimly lit, quite room for 30 minutes. Respiratory gas exchange was measured for 15 minutes, using the last 10 minutes to average REE. Tests were examined for validity to confirm a) average RQ was 0.7-0.9, and b) average Metabolic Equivalents (METs) <1.10. If the averaged data fell outside of these ranges, the test was considered invalid and excluded from the analysis. REE was collected on days 1 and 8 of the free-living monitoring period, and averaged to produce a single value for REE (intraclass correlation coefficient = 0.96).
Measured: Day 1 and Day 8 over a 1 week period
Thermic Effect of Food (TEF)
The thermic effect of food (TEF) was calculated as 10% of TDEE.
Measured: At 8 days
Physical Activity Level (PAL)
PAL was calculated as TDEE/REE.
Measured: At 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startOct 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Colorado, DenverThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Victoria Catenacci, MD, Principal investigator, University of CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422380
- Sponsor's protocol ID
- 07-0584
- Other IDs
- 1K23DK078913
- Status last verified
- Jan 2018
- First submitted
- 30 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dahle JH, Ostendorf DM, Zaman A, Pan Z, Melanson EL, Catenacci VA. Underreporting of energy intake in weight loss maintainers. Am J Clin Nutr. 2021 Jul 1;114(1):257-266. doi: 10.1093/ajcn/nqab012.
PubMed 33742193Ostendorf DM, Caldwell AE, Creasy SA, Pan Z, Lyden K, Bergouignan A, MacLean PS, Wyatt HR, Hill JO, Melanson EL, Catenacci VA. Physical Activity Energy Expenditure and Total Daily Energy Expenditure in Successful Weight Loss Maintainers. Obesity (Silver Spring). 2019 Mar;27(3):496-504. doi: 10.1002/oby.22373.
PubMed 30801984Ostendorf DM, Melanson EL, Caldwell AE, Creasy SA, Pan Z, MacLean PS, Wyatt HR, Hill JO, Catenacci VA. No consistent evidence of a disproportionately low resting energy expenditure in long-term successful weight-loss maintainers. Am J Clin Nutr. 2018 Oct 1;108(4):658-666. doi: 10.1093/ajcn/nqy179.
PubMed 30321282
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure in Subjects Successful at Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT03422380
- Acronym / sponsor ID
- 07-0584
- Conditions
- Obesity, Weight Change, Body, Weight Loss, Physical Activity
- Keywords
- energy expenditure, adaptive thermogenesis, metabolic adaptation, weight loss maintenance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2009 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Feb 2018 (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.
Obesity is reaching epidemic proportions and threatens both health and quality of life of people around the world. While many individuals succeed at short term weight loss, weight loss maintenance is the greatest barrier to successful treatment of obesity. High levels of physical activity are consistently associated with success in weight loss maintenance. The major goal of this proposal is to understand how and why high levels of physical activity are critical for long term maintenance of weight loss. This project takes advantage of the National Weight Control Registry (NWCR), which follows over 6000 individuals who have maintained a weight loss of ≥30 pounds for ≥1 year. Understanding how individuals successful at weight loss maintenance achieve energy balance will provide important insight into strategies to help more people sustain a weight loss.
Detailed description
Participants were recruited in three groups: weight loss maintainers (WLM: maintaining ≥13.6 kg weight loss for ≥1 year), normal weight controls (NC: Body Mass Index (BMI) matched to current BMI of WLM), and controls with overweight/obesity (Overweight Controls (OC): BMI matched to pre-weight loss maximum BMI of WLM). The investigators hypothesize that total daily energy expenditure (TDEE) in WLM is similar to OC but is significantly higher then NC. High levels of volitional physical activity may compensate for the reduction in energy expenditure ("energy gap") that is the expected result of weight loss. This allows WLM to maintain a high level of "energy flux", which may facilitate optimal body weight regulation over time. The investigators will use doubly labeled water to compare TDEE in WLM and both NC and OC. The investigators will also compare individual components of TDEE including resting energy expenditure (REE), thermic effect of food (TEF), physical activity energy expenditure (PAEE), and physical activity level (PAL) between groups. The investigators also hypothesize that REE in WLM is similar to controls of both types under free living conditions, but will decrease following a period of physical inactivity and be significantly less than controls. Studies in rodents have consistently shown evidence of an increase in metabolic efficiency in the reduced obese state manifested by a lower than predicted REE. Studies in humans have shown mixed results, however few studies have controlled for habitual level of physical activity. Recent evidence suggests REE is greater in adults who perform regular exercise than their sedentary peers; this difference can be attributed in part to greater tonic sympathetic nervous system stimulation of REE that occurs in habitually exercising adults. The investigators believe there is an increase in metabolic efficiency in the reduced obese state manifested by a lower than predicted REE, and that high levels of physical activity function to "mask" or "correct" this metabolic efficiency. The investigators will compare REE under free living conditions and during an experimentally imposed period of reduced energy flux (restricted physical activity matched by an equivalent reduction in energy intake) in WLM and controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Maintainers (WLM) | – | –Individuals maintaining ≥13.6 kg (30 lb) weight loss for ≥1 year |
| Normal Weight Controls (NC) | – | –Individuals with normal weight whose BMI was matched to the current BMI of the WLM. NC had to be weight stable and not maintaining a weight loss of ≥13.6kg |
| Controls with Overweight/Obesity (OC) | – | –Individuals with overweight/obesity whose BMI was matched to the pre-weight loss maximum BMI of WLM. OC had to be weight stable and not maintaining a weight loss of ≥13.6kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The proposed study design is aimed at collecting additional data on previously enrolled adult study subjects in the NWCR, which does not include children. The NWCR contains approximately 70% women and 30% men. We anticipate studying equal numbers of men and women in this study. Minorities comprise approximately 7% of total subjects in the NWCR. In the proposed studies, there will be no exclusions for racial or ethnic background.
Key inclusion criteria (6 listed)
- Men or women
- Age 18-65
- Weight stable (<10 lb fluctuation in body weight over previous 6 months) or
- NWCR subjects successful at weight loss maintenance (maintaining a loss of ≥ 30 pounds for at least 2 years)
- Non-Reduced Weight Matched Controls: Individuals matched to NWCR subjects' current body weight. These individuals will be normal weight (BMI 18-25, BMI up to 27 allowed in men with waist circumference < 40 cm), and have no history of overweight or obesity (BMI >25) and will not be maintaining a weight loss ≥ 30 pounds.
Key exclusion criteria (20 listed)
- Diabetes
- Uncontrolled HTN (>160/100)
- History of cardiac disease: CHF or angina, atrial fibrillation or ventricular tachycardia, or significant abnormality on resting EKG
- Symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, dizziness, syncope.
- History of neurological disease: stroke, TIA or seizure disorder
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
Total Daily Energy Expenditure (TDEE)
Time frame: At 8 days
After a 12-hour overnight fast, participants provided a baseline urine sample on day 1. Participants were then administered an oral dose of doubly labeled water (DLW) containing 1.8g 10% 18O/kg total body water (TBW) and 0.12 g/kg TBW of 99.9% deuterium. TBW was estimated as 73% of FFM from DXA. The dosing cup was rinsed twice with 30 mL of water and the rinsing dose consumed. Exact time of dosing was recorded. Additional urine samples were collected after a 4hr and 5hr post-dose equilibrium period and then again at the same times on day 8. TDEE over days 1-8 was determined using a single DLW dose and the two-point method according to Schoeller and colleagues.
4 secondary outcomes
Physical Activity Energy Expenditure (PAEE)
Time frame: At 8 days
Resting Energy Expenditure (REE)
Time frame: Day 1 and Day 8 over a 1 week period
Thermic Effect of Food (TEF)
Time frame: At 8 days
Physical Activity Level (PAL)
Time frame: At 8 days
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 5 Feb 2018.
- Derived from this study: PubMed 33742193Dahle JH, Ostendorf DM, Zaman A, Pan Z, Melanson EL, Catenacci VA. Underreporting of energy intake in weight loss maintainers. Am J Clin Nutr. 2021 Jul 1;114(1):257-266. doi: 10.1093/ajcn/nqab012.
- Derived from this study: PubMed 30801984Ostendorf DM, Caldwell AE, Creasy SA, Pan Z, Lyden K, Bergouignan A, MacLean PS, Wyatt HR, Hill JO, Melanson EL, Catenacci VA. Physical Activity Energy Expenditure and Total Daily Energy Expenditure in Successful Weight Loss Maintainers. Obesity (Silver Spring). 2019 Mar;27(3):496-504. doi: 10.1002/oby.22373.
- Derived from this study: PubMed 30321282Ostendorf DM, Melanson EL, Caldwell AE, Creasy SA, Pan Z, MacLean PS, Wyatt HR, Hill JO, Catenacci VA. No consistent evidence of a disproportionately low resting energy expenditure in long-term successful weight-loss maintainers. Am J Clin Nutr. 2018 Oct 1;108(4):658-666. doi: 10.1093/ajcn/nqy179.
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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.
Victoria Catenacci, MD principal investigator
University of CO
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 Weight Change, Body, run by University of Colorado, Denver 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 20 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 5 Feb 2018. 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?
Total Daily Energy Expenditure (TDEE) (time frame: At 8 days). 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 NCT03422380, which also lists 3 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 5 Feb 2018.