Assessment of Energy Balance
EnergyBalanc
1 other identifier
interventional
87
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 31, 2012
CompletedFirst Posted
Study publicly available on registry
September 5, 2012
CompletedResults Posted
Study results publicly available
September 22, 2014
CompletedMay 31, 2017
February 1, 2017
2.6 years
August 31, 2012
December 20, 2012
May 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Weight Change
1 year
Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
1 week
Device Predictions of % Weight Change During and After an 8-week LCD
8 weeks
Study Arms (2)
Sub-study 1, Dig Photo, Actical & IDEEA
EXPERIMENTALDuring 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.
Sub-study 2 - Dig Photo & Sensewear
EXPERIMENTALDuring 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study included a 2-week doubly labeled water phase; hence, the activity and energy intake assessments were limited this period.
Results Point of Contact
- Title
- Corby Martin, Ph.D.
- Organization
- Pennington Biomedical Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
Corby K Martin, Ph.D.
Pennington Biomedical Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 31, 2012
First Posted
September 5, 2012
Study Start
May 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 31, 2017
Results First Posted
September 22, 2014
Record last verified: 2017-02