Assessment of Energy Balance (EnergyBalanc)

Pennington Biomedical Research Center

Status: Completed

Conditions: Caloric Intake and Energy Metabolism

Treatments: Device: Sensewear Armband; Behavioral: low-calorie diet; Other: doubly labeled water; Behavioral: Digital Photography of Foods; Device: IDEEA; Device: Actical

Study type: Interventional

Funder types: Other

Identifiers

NCT01678885

PBRC 27007

Details and patient eligibility

About

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).

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Sub-study 1, Dig Photo, Actical & IDEEA

Experimental group

Description:

During one week of the doubly labeled water (DLW), participants will use digital photography of foods. During the other week of the DLW phase, participants will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and Actical monitor. Whether the participants wear the monitors first or complete digital photography first will be randomozed. 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.

Treatment:

Device: IDEEA

Behavioral: Digital Photography of Foods

Other: doubly labeled water

Device: Actical

Behavioral: low-calorie diet

Sub-study 2 - Dig Photo & Sensewear

Experimental group

Description:

During one week of the doubly labeled water (DLW) period, participants will use digital photography of foods. During the other week of the DLW phase, participants will wear the Sensewear armband. Whether the participants wear the monitor first or complete digital photography first will be randomozed. 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.

Treatment:

Device: Sensewear Armband

Behavioral: Digital Photography of Foods

Other: doubly labeled water

Behavioral: low-calorie diet