Clinical trial NCT01678885: Assessment of Energy Balance
Official title: Assessment of Energy Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caloric Intake and Energy Metabolism
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY
timeFrame: ~6 days
Secondary outcomes:
measure: Weight Change
timeFrame: 1 year
measure: Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
timeFrame: 1 week
measure: Device Predictions of % Weight Change During and After an 8-week LCD
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Corby K Martin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: