Energy Expenditure and Weight Loss Maintenance

NCT ID: NCT03422380

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Weight Change, Body Weight Loss Physical Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Weight Loss Maintainers (WLM)

Individuals maintaining ≥13.6 kg (30 lb) weight loss for ≥1 year

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).

Exclusion Criteria

* 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)
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Victoria Catenacci, MD

Role: PRINCIPAL_INVESTIGATOR

University of CO

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33742193 (View on PubMed)

Ostendorf 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.

Reference Type DERIVED
PMID: 30801984 (View on PubMed)

Ostendorf 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.

Reference Type DERIVED
PMID: 30321282 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1K23DK078913

Identifier Type: NIH

Identifier Source: secondary_id

View Link

07-0584

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise and Weight Control
NCT03413826 COMPLETED NA
Physical Activity Choices Everyday
NCT03824769 COMPLETED NA