Assessment of Energy Balance
The purpose of this study is to test different methods of measuring energy balance, including food intake and energy expenditure. Another purpose of this study is to see if energy expenditure predicts weight and change after a weight loss diet.
Caloric Intake and Energy Metabolism
Behavioral: Digital Photography of Foods
Other: doubly labeled water
Behavioral: low-calorie diet
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of Energy Balance|
- ENERGY BALANCE EQUATION [ Time Frame: 2 days ] [ Designated as safety issue: No ]A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.
- Weight Change [ Time Frame: 1 year ] [ Designated as safety issue: No ]The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss
|Study Start Date:||May 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Baseline then Followup
During the first week of the doubly labeled water (DLW) period, participants in group 1 will use digital photography of foods. During the second week of the DLW phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the DLW period and digital photography of foods during the second week. Participants who complete the first two weeks and have a BMI over 25kg/m2 will receive a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan is a 1000-1150 kcal/day diet that participants will complete in a free-living environment. All participants will return to follow-up at six and twelve months after they completed the LCD. Anthropometric and questionnaire data will be collected.
Behavioral: Digital Photography of Foods
The digital photography of foods method was developed to unobtrusively measure energy intake in naturalistic settings (e.g., cafeterias). Participants will be provided with cell-phones with digital cameras and cellular network capability. Participants were trained to take pictures of their food selection and plate waste and to send these pictures to the researchers over the cellular network. The participant will collect data in free-living conditions and these data will be collected in near real time.
Other Name: digital photographyOther: doubly labeled water
Doubly labeled water, considered the gold standard for measuring energy intake in humans, was used to measure total daily energy expenditure during free-living conditions. DLW is used to obtain an accurate measure of total daily energy expenditure, which is equal to energy intake during energy balance.
Other Name: Doubly labeled water (DLW)Device: IDEEA
The Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
Other Name: Intelligent Device for Energy Expenditure and ActivityBehavioral: low-calorie diet
Participants will be instructed to consume five packets of Health One per day, which provides 800 kcal and 125% of Recommended Daily Intake of vitamins and minerals. Additionally participants will be instructed to consume a meal consisting of 200 kcal to 350 kcal daily, which could consist of a portion-controlled meal replacement or a home-cooked meal. Participants will meet with a Registered Dietitian at weeks 0, 2, 4, and 6 and receive instructions on adhering to the meal plan.
Other Name: LCD
The study will take place over a period of one year. Participants will spend 3 weeks completing Phase I, and eight weeks completing Phase II (the weight loss phase of the study). Then, participants will return to the center at months 6 and 12 for a follow-up visit. During these visits, body weight, blood pressure, and pulse will be recorded, and questionnaires about eating attitudes and habits will be collected and assessed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678885
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Corby K Martin, Ph.D.||Pennington Biomedical Research Center|