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

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Valparaiso
    • Valparaíso, Valparaiso, Chile
      • School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants keep their normal routine without intervention.
Experimental: Experimental group; 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; 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	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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Valparaiso

Study record dates

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 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• 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