NCT04097626

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

September 17, 2019

Last Update Submit

January 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    change between baseline and visit 5 (six weeks after date of enrollment)

Study Arms (2)

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

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.

Other: no nutrition education

Interventions

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.

experimental

This group will not receive nutrition education.

control

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant women (self-reported).
  • Currently injured that would prevent subjects from exercising.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • JeJe Noval, PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Nutrition and Dietitics

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 20, 2019

Study Start

October 1, 2019

Primary Completion

January 28, 2020

Study Completion

January 28, 2020

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations