Assessment of Energy Balance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Energy Balance

Conditions
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Caloric Intake and Energy Metabolism

Intervention / Treatment
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* Behavioral: Digital Photography of Foods
* Other: doubly labeled water
* Device: IDEEA
* Behavioral: low-calorie diet
* Device: Actical
* Device: Sensewear Armband


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sub-study 1, Dig Photo, Actical & IDEEA<br>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. | Behavioral: Digital Photography of Foods<br>* 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.<br>* Other names: digital photography;Other: doubly labeled water<br>* 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.<br>* Other names: Doubly labeled water (DLW);Device: IDEEA<br>* 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.<br>* Other names: Intelligent Device for Energy Expenditure and Activity;Behavioral: low-calorie diet<br>* 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.<br>* Other names: LCD;Device: Actical<br>* The Actical will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.<br>|
| Experimental: Sub-study 2 - Dig Photo & Sensewear<br>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. | Behavioral: Digital Photography of Foods<br>* 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.<br>* Other names: digital photography;Other: doubly labeled water<br>* 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.<br>* Other names: Doubly labeled water (DLW);Behavioral: low-calorie diet<br>* 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.<br>* Other names: LCD;Device: Sensewear Armband<br>* The Sensewear armband will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY | 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. |  6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | 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. | 1 year | 
| Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day) | Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis. | 1 week | 
| Device Predictions of % Weight Change During and After an 8-week LCD | This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI's < 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis | 8 weeks |