Quantifying the Persistence of Metabolic Adaptation and Weight Regain Following Extreme Weight Loss

NCT02544009 | Completed

• 2 other identifiers: 15019215-DK-0192
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Energy Expenditure

Keywords

Energy Expenditure; Obesity; Behavioral Weight Loss Treatment; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Study Arms (1)

1

16 subjects who previously participated in the Biggest Loser study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• subjects who previously participated in the Biggest Loser study (Pennington Biomedical Research Center protocol no. PBRC29008).
• Written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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.

  PMID: 29086499 DERIVED

• Fothergill 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.

  PMID: 27136388 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Hall, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2015
• First Posted: September 9, 2015
• Study Start: September 5, 2015
• Primary Completion: May 19, 2016
• Study Completion: May 19, 2016
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

US (1)