Back to resultsEffect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students With Overweight and Obesity
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Educational talk about physical activity and nutritional recommendations before a critical period of fat gain in university students
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Experimental group
Arm Description
Participants keep their normal routine without intervention.
Participants receive a single nutritional intervention previous to a critical period.
Outcomes
Primary Outcome Measures
Body composition measurements
Changes on fat mass measured by DXA
Secondary Outcome Measures
Feeding questionnaires and food guide recommendations
Changes on the Global Food Index
Feeding questionnaires and food guide recommendations
Changes on the KIDMED index (questionnaire establishes the adherence to the Mediterranean diet)
Feeding questionnaires and food guide recommendations
Changes on the Food Guide Recommendation
Physical activity level
Modification on physical activity level measured by accelerometry
Full Information
NCT ID
NCT04463407
First Posted
June 26, 2020
Last Updated
July 8, 2020
Sponsor
Pontificia Universidad Catolica de Valparaiso
1. Study Identification
Unique Protocol Identification Number
NCT04463407
Brief Title
Effect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students With Overweight and Obesity
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontificia Universidad Catolica de Valparaiso
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants keep their normal routine without intervention.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants receive a single nutritional intervention previous to a critical period.
Intervention Type
Other
Intervention Name(s)
Educational talk about physical activity and nutritional recommendations before a critical period of fat gain in university students
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body composition measurements
Description
Changes on fat mass measured by DXA
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Feeding questionnaires and food guide recommendations
Description
Changes on the Global Food Index
Time Frame
3 weeks
Title
Feeding questionnaires and food guide recommendations
Description
Changes on the KIDMED index (questionnaire establishes the adherence to the Mediterranean diet)
Time Frame
3 weeks
Title
Feeding questionnaires and food guide recommendations
Description
Changes on the Food Guide Recommendation
Time Frame
3 weeks
Title
Physical activity level
Description
Modification on physical activity level measured by accelerometry
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
City
Valparaíso
State/Province
Valparaiso
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All participant data are private.
Learn more about this trial
Effect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students With Overweight and Obesity
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