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

Sponsor

Loma Linda University (Other)

Overall Status

Completed

CT.gov ID

NCT04097626

Collaborator

(none)

Enrollment

Location

Arms

3.9

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

6 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 :

Oct 1, 2019

Actual Primary Completion Date :

Jan 28, 2020

Actual Study Completion Date :

Jan 28, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Body Fat Percentage [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University	Loma Linda	California	United States	92350

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator: JeJe Noval, PhD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JeJe Noval, Assistant Professor, Department of Nutrition and Dietitics, Loma Linda University

ClinicalTrials.gov Identifier:

NCT04097626

Other Study ID Numbers:

5190325

First Posted:

Sep 20, 2019

Last Update Posted:

Jan 29, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 29, 2020