Effect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students With Overweight and Obesity
July 27, 2026 updated by: Carlos Cristi Montero, Pontificia Universidad Catolica de Valparaiso
Efectividad de Una intervención Educativa Preventiva Previa a Vacaciones de Fiestas Patrias Sobre la composición Corporal, hábitos de alimentación y Niveles de Actividad física en Estudiantes Universitarios: Estudio Aleatorizado Controlado
The present study aimed to investigate the effects of a single nutritional preventive session previous to a critical period linked to fat gain in university students with overweight and obesity, emulating a nutritional session of a public health system.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Valparaiso
-
Valparaíso, Valparaiso, Chile
- School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Body mass index [BMI] ≥25 kg/m2
- Not having metal plates
- Not studying Nutrition and Dietetics or Physical Education
- Not being pregnant
Exclusion Criteria:
- Presente gastrointestinal problems (vomit or diarrheas) during the three weeks that last the experiment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Routine - No Counseling
Participants keep their habitual lifestyle and receive no preventive counseling before the Chilean National Holidays.
|
|
|
Experimental: Single 20-min Nutrition & PA Counseling
One 20-min face-to-face session (DXA feedback, nutritional assessment, education on healthy eating & physical activity + 6 tailored recommendations) delivered ≈ 2 wk before National Holidays.
|
An intervention was performed emulating a traditional nutritional session from a primary healthcare center (public health system).
Traditionally, this session lasts around 20 minutes and includes a body composition measurement, nutritional assessment, and a brief educational talk about healthy eating.
Just the intervention group received a series of healthy recommendations specially focused on the National Holiday.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition measurements
Time Frame: 3 weeks
|
Changes on fat mass measured by Dual X-ray Absorptiometry (DXA)
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feeding questionnaires and food guide recommendations
Time Frame: 3 weeks
|
Changes on the Food Guide Recommendation
|
3 weeks
|
|
Physical activity level
Time Frame: 3 weeks
|
Modification on physical activity level measured by accelerometry
|
3 weeks
|
|
Feeding questionnaires and food guide recommendations
Time Frame: 3 weeks
|
Changes on the Global Food Index.
The Global Food Index is a 12-item frequency questionnaire assessing adherence to the Chilean Food Guide.
Each item is scored from 1 (least healthy) to 10 (most healthy); total score range = 12 - 120.
Higher scores indicate a healthier diet.
Change is calculated as Week 3 minus Baseline.
|
3 weeks
|
|
Feeding questionnaires and food guide recommendations
Time Frame: 3 weeks
|
Changes on the KIDMED index (questionnaire establishes the adherence to the Mediterranean diet).
The Mediterranean Diet Quality Index (KIDMED) contains 16 yes/no items (12 positive = +1; 4 negative = -1).
Total score range = 0 - 12; higher scores denote better adherence to the Mediterranean diet (0-3 poor, 4-7 average, 8-12 good).
Change is calculated as Week 3 minus Baseline.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2017
Primary Completion (Actual)
September 27, 2017
Study Completion (Actual)
September 28, 2017
Study Registration Dates
First Submitted
June 26, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2026
Last Update Submitted That Met QC Criteria
July 27, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIOEPUCV-H145-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All participant data are private.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.