At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomised Controlled Trial to Evaluate Impact of Energy Expenditure Information on the Outcome of Weight Loss During a Standardised Multicomponent Weight Management Intervention
In Brief
A clinical study evaluating ECAL Indirect Calorimeter and Diet, exercise & behaviour modification therapy for Obesity and 2 related conditions. Completed, enrolled 51 participants across 1 site.
Detailed Summary
Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. In some cases, relatively reduced rates of 24h EE predict weight gain in some populations who have high prevalence of obesity. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.
Study Details
Timeline
Interventions
The ECAL is an open-circuit portable indirect calorimeter that measures both volume of CO2 expired and O2 consumed using a small mixing chamber. Participants will breathe through a mouthpiece with a nose clip applied whilst lying in a restful and comfortable position for 15 minutes. ECAL device will provide breath-by-breath measurements of the resting energy expenditure and respiratory quotient which will allow both practitioners and participants to monitor their metabolic health and compare the effect of dietary and physical activity intervention over the course of the structured intensive lifestyle intervention (24-weeks).
Standard care (SC) - participants receive standard care (diet, exercise \& behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention.