N/A
N=87
Assessment of Energy Balance
Caloric Intake and Energy Metabolism
Bottom Line
View on ClinicalTrials.gov: NCT01678885 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY — 2360; 2208; -152 kCal
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Digital Photography of Foods (Behavioral); doubly labeled water (Other); IDEEA (Device); low-calorie diet (Behavioral); Actical (Device); Sensewear Armband (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY |
2360; 2208; -152 | — |
| SECONDARY Weight Change |
-6.3 | — |
| SECONDARY Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day) |
-59.98; 121.72; -111.38; 194.52; -416.95; 108.77 | — |
| SECONDARY Device Predictions of % Weight Change During and After an 8-week LCD |
0.00; 0.00; 0.00; 0.10; .03 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01678885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.