Sedentary LifestyleNCT04097626
The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program
A study testing nutrition education and no nutrition education in people with Sedentary Lifestyle, run by Loma Linda University at 1 site in United States.
Trial summary
To examine whether starting an exercise program with or without education can influence dietary choices in previously sedentary of 20-40 years. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- nutrition education and no nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 28 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women (self-reported).
- Currently injured that would prevent subjects from exercising.
Trial locations and contacts
1 site in 1 country.
About this study
To examine whether starting an exercise program with or without education can influence dietary choices in previously sedentary of 20-40 years.
Read the 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).
- Conditions
- Sedentary Lifestyle
- Being tested
- nutrition education, no nutrition education
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition educationOther
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.
no nutrition educationOther
This group will not receive nutrition education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: nutrition education |
| control | Active comparator | 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. Receives: Other: no nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat Percentage
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.
Measured: change between baseline and visit 5 (six weeks after date of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Oct 2019
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JeJe Noval, Loma Linda University
- Investigators
- JeJe Noval, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097626
- Sponsor's protocol ID
- 5190325
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program
- ClinicalTrials.gov ID
- NCT04097626
- Acronym / sponsor ID
- 5190325
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine whether starting an exercise program with or without education can influence dietary choices in previously sedentary of 20-40 years.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: nutrition educationThis 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. |
| control | Active comparator | Other: no nutrition educationThis 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant women (self-reported).
- Currently injured that would prevent subjects from exercising.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition educationThe 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. | Other | experimental |
| no nutrition educationThis group will not receive nutrition education. | Other | control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JeJe Noval, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition education and no nutrition education in people with Sedentary Lifestyle, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat Percentage (time frame: change between baseline and visit 5 (six weeks after date of enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.