Energy Expenditure and Weight Loss Maintenance
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|ClinicalTrials.gov Identifier: NCT03422380|
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
|Condition or disease|
|Obesity Weight Change, Body Weight Loss Physical Activity|
|Study Type :||Observational|
|Actual Enrollment :||112 participants|
|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|
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.
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|