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Assessment of Energy Balance

This study has been completed.
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center Identifier:
First received: August 31, 2012
Last updated: September 19, 2014
Last verified: September 2014
The purpose of this study is to test different methods of measuring energy balance, including food intake and energy expenditure. Another purpose of this study is to see if energy expenditure predicts weight and change after a weight loss diet.

Condition Intervention
Caloric Intake and Energy Metabolism
Behavioral: Digital Photography of Foods
Other: doubly labeled water
Device: IDEEA
Behavioral: low-calorie diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Energy Balance

Further study details as provided by Corby K. Martin, Pennington Biomedical Research Center:

Primary Outcome Measures:
  • ENERGY BALANCE EQUATION [ Time Frame: 2 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. 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 Outcome Measures:
  • Weight Change [ Time Frame: 1 year ]
    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

Enrollment: 40
Study Start Date: May 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baseline then Followup
During the first week of the doubly labeled water (DLW) period, participants in group 1 will use digital photography of foods. During the second week of the DLW phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the DLW period and digital photography of foods during the second week. 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
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.
Other Name: digital photography
Other: doubly labeled water
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.
Other Name: Doubly labeled water (DLW)
Device: IDEEA
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.
Other Name: Intelligent Device for Energy Expenditure and Activity
Behavioral: low-calorie diet
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.
Other Name: 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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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.
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Please refer to this study by its identifier: NCT01678885

United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Principal Investigator: Corby K Martin, Ph.D. Pennington Biomedical Research Center
  More Information

Responsible Party: Corby K. Martin, Principal Investigator, Pennington Biomedical Research Center Identifier: NCT01678885     History of Changes
Other Study ID Numbers: PBRC27007 Energy Balance
Study First Received: August 31, 2012
Results First Received: December 20, 2012
Last Updated: September 19, 2014 processed this record on May 25, 2017