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The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program

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ClinicalTrials.gov Identifier: NCT04097626
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
JeJe Noval, Loma Linda University

Brief Summary:
To examine whether starting an exercise program with or without education can influence dietary choices in previously sedentary of 20-40 years.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Other: nutrition education Other: no nutrition education Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.
Other: nutrition education
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.
Other: no nutrition education
This group will not receive nutrition education.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097626


Contacts
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Contact: JeJe Noval, PhD 9095584000 ext 87462 jnoval@llu.edu

Locations
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United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92350
Contact: JeJe Noval, PhD         
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: JeJe Noval, PhD Loma Linda University

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Responsible Party: JeJe Noval, Assistant Professor, Department of Nutrition and Dietitics, Loma Linda University
ClinicalTrials.gov Identifier: NCT04097626     History of Changes
Other Study ID Numbers: 5190325
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No