Assessment of Energy Balance
Condition: Caloric Intake and Energy Metabolism
Study type: Interventional

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.
    

Intervention name(s): Digital Photography of Foods; doubly labeled water; IDEEA; low-calorie diet; Actical; Sensewear Armband
Intervention type(s): Behavioral; Other; Device; Behavioral; Device; Device
Intervention description(s): 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.; 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.; 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.; 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.; The Actical will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.; The Sensewear armband will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
Other intervention name(s): digital photography; Doubly labeled water (DLW); Intelligent Device for Energy Expenditure and Activity; LCD
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment