Completed
EnergyBalancAssessment of Energy Balance
What is being tested
Digital Photography of Foods
+ doubly labeled water
+ IDEEA
BehavioralOtherDevice
Who is being recruted
From 18 to 65 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: May 2007
Summary
Principal SponsorPennington Biomedical Research Center
Last updated: May 31, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2007
Actual date on which the first participant was enrolled.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.
Principal SponsorPennington Biomedical Research Center
Last updated: May 31, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
87 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
7 inclusion criteria required to participate
18-65 years
Body Mass Index 25-40
Willing to eat foods provided for two days
Willing to undergo an 8 week weight loss diet, consisting of supplement or powdered shakes, portion-controlled entrees, or home-cooked meals
Show More Criteria
3 exclusion criteria prevent from participating
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
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.
Group II
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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Pennington Biomedical Research Center
Baton Rouge, United StatesOpen Pennington Biomedical Research Center in Google MapsCompletedOne Study Center