Assessment of Energy Balance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01678885
First received: August 31, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • TEST THE VALIDITY OF BOTH SIDES OF ENERGY BALANCE EQUATION. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    A new method of digital photography of foods to measure the energy intake and macronutrient intake of free-living humans will be tested. Digital photography Energy Intake will be tested against measured food provisions during an in-feeding period and against energy intake measured with doubly labeled water during free-living conditions. Energy Intake 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 doubly labeled water.


Secondary Outcome Measures:
  • Posture allocation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Posture allocation refers to the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities which the secondary aim is to test if posture allocation 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: Phase I Group 1
During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.
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: 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
Experimental: Phase 1 Group 2
Participants in Phase I Group 2 will complete the same procedures as participants in Phase I Group 1, but in the opposite order. They will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer for the first week of the doubly labeled water, and use digital photography of foods during the second week of the doubly labeled water period.
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: 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
Experimental: Phase II
Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan is a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants will complete in a free-living environment. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678885

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

No publications provided

Responsible Party: Corby K. Martin, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01678885     History of Changes
Other Study ID Numbers: Energy Balance
Study First Received: August 31, 2012
Last Updated: August 31, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 20, 2014