Energy Expenditure and Weight Loss Maintenance
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03422380 |
Recruitment Status :
Completed
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Obesity Weight Change, Body Weight Loss Physical Activity |
Study Type : | Observational |
Actual Enrollment : | 112 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Energy Expenditure in Subjects Successful at Weight Loss Maintenance |
Actual Study Start Date : | October 2009 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Group/Cohort |
---|
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
|
- 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.
- Physical Activity Energy Expenditure (PAEE) [ Time Frame: At 8 days ]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).
- Resting Energy Expenditure (REE) [ Time Frame: Day 1 and Day 8 over a 1 week period ]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).
- Thermic Effect of Food (TEF) [ Time Frame: At 8 days ]The thermic effect of food (TEF) was calculated as 10% of TDEE.
- Physical Activity Level (PAL) [ Time Frame: At 8 days ]PAL was calculated as TDEE/REE.
- Physical Activity Patterns [ Time Frame: At 8 days ]PA patterns were assessed using the activPALTM activity monitor (PAL Technologies, Glasgow, Scotland). The activPALTM is a small (23x43x5 mm) and lightweight (10 grams) device that uses accelerometer-derived information about thigh position to estimate time spent sitting/lying, standing, and stepping. The device is attached to the anterior thigh and is waterproofed by wrapping it in a nitrile sleeve, allowing for 24-hour measurement. Participants were asked to wear the device continuously for seven days.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422380
United States, Colorado | |
University of Colorado Anschutz Medical Campus | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Victoria Catenacci, MD | University of CO |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT03422380 |
Other Study ID Numbers: |
07-0584 1K23DK078913 ( U.S. NIH Grant/Contract ) |
First Posted: | February 5, 2018 Key Record Dates |
Last Update Posted: | February 5, 2018 |
Last Verified: | January 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
energy expenditure adaptive thermogenesis metabolic adaptation weight loss maintenance |
Body Weight Weight Loss Body Weight Changes |