Assessment of Energy Balance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 87
- Locations
- 2
- Primary Endpoint
- ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY
Study Overview
Brief Summary
The primary purpose of this study is to test different methods of measuring energy balance, including food intake and energy expenditure. Another primary purpose of this study is to see if energy expenditure predicts weight and change after a weight loss diet. A secondary aim will be to test the reliability and validity of the Actical accelerometer, SenseWear Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated energy expenditure or posture allocation from the 3 devices is associated with weight change during and following a low calorie diet (LCD).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-65 years
- •Body Mass Index 25-40
- •Willing to eat foods provided for two days.
- •Willing to wear the IDEEA( Intelligent Device for Energy Expenditure and Activity), which is a device that attaches to the body and records movement and activity.
- •Willing to wear an accelerometer, which is similar to a pager that attaches to belt or clothing and measures activity.
- •Willing to use a cell phone equipped with a digital camera to take pictures of foods for one week.
- •Willing to undergo an 8 week weight loss diet, consisting of supplement or powdered shakes, portion-controlled entrees, or home-cooked meals.
Exclusion Criteria
- •A diagnosis of diabetes, cardiovascular disease, or cancer.
- •Females who are pregnant or planning to become pregnant during the trail.
- •Medications that influence appetite or body weight (weight loss medications such as sibutramine, antipsychotic medications such as olanzapine, or herbal weight loss products) taken during the previous three months.
Outcomes
Primary Outcomes
ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY
Time Frame: ~6 days
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 for 1 week. 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.
Secondary Outcomes
- Weight Change(1 year)
- Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)(1 week)
- Device Predictions of % Weight Change During and After an 8-week LCD(8 weeks)
Investigators
Corby K. Martin
Principal Investigator
Pennington Biomedical Research Center