- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097626
The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will complete an InBody test, demographic and physical activity survey, and food-frequency questionnaire via Qualtrics. Also, subjects may participate in a focus group and an individual interview.
A minimum of 150 minutes of moderate exercise required each week and must be spread out in at least 2 days.
Over the course of the study, subjects will complete InBody assessments, Food Frequency Questionnaire (items subjects are eating before, during, and after the investigator's study), and possible focus group questions (open-ended questions about thoughts and perceptions on exercise, nutrition knowledge, and health and nutrition history).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Loma Linda, California, United States, 92350
- Loma Linda University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and Women between 20 and 50 years.
- Previously sedentary for at least 6 months but have been exercising between one week and three months.
- Must be able to perform moderate intensity exercise at least two days per week in at least 30-minute sessions.
Exclusion Criteria:
- Pregnant women (self-reported).
- Currently injured that would prevent subjects from exercising.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental
This group will receive nutrition education during the first week of the study.
This group will perform a minimum of 150 minutes of moderate exercise each week and must be spread out in at least 2 days.
|
The experimental group will receive nutrition education once during the study.
It will occur at the beginning of the second week.
This will consist of a 30-minute interactive lecture and a 15-minute question-and-answer session.
The information covered will be basic nutrition principles for good health and to support regular exercise.
|
Active Comparator: control
This group will receive no nutrition education.
This group will perform a minimum of 150 minutes of moderate exercise each week and must be spread out in at least 2 days.
|
This group will not receive nutrition education.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Fat Percentage
Time Frame: change between baseline and visit 5 (six weeks after date of enrollment)
|
Body fat percentage will be tested using the InBody 770.
This test will take less than 5 minutes to complete.
The InBody 770 calculates the measured data using bioelectrical impedance.
The testing will be done in the morning around the same time for each participant.
Participants will be asked to refrain from eating or drinking that morning to be able to get the most accurate reading.
|
change between baseline and visit 5 (six weeks after date of enrollment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: JeJe Noval, PhD, Loma Linda University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5190325
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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