Effect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students With Overweight and Obesity

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Educational talk about physical activity and nutritional recommendations before a critical period of fat gain in university students


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Participants keep their normal routine without intervention. | |
| Experimental: Experimental group<br>Participants receive a single nutritional intervention previous to a critical period. | Other: Educational talk about physical activity and nutritional recommendations before a critical period of fat gain in university students<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition measurements | Changes on fat mass measured by DXA | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding questionnaires and food guide recommendations | Changes on the Global Food Index | 3 weeks | 
| Feeding questionnaires and food guide recommendations | Changes on the KIDMED index (questionnaire establishes the adherence to the Mediterranean diet) | 3 weeks | 
| Feeding questionnaires and food guide recommendations | Changes on the Food Guide Recommendation | 3 weeks | 
| Physical activity level | Modification on physical activity level measured by accelerometry | 3 weeks |