NCT04463407

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable obesity

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

Study Start

First participant enrolled

August 28, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

June 26, 2020

Last Update Submit

July 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body composition measurements

    Changes on fat mass measured by DXA

    3 weeks

Secondary Outcomes (4)

  • Feeding questionnaires and food guide recommendations

    3 weeks

  • Feeding questionnaires and food guide recommendations

    3 weeks

  • Feeding questionnaires and food guide recommendations

    3 weeks

  • Physical activity level

    3 weeks

Study Arms (2)

Control group

NO INTERVENTION

Participants keep their normal routine without intervention.

Experimental group

EXPERIMENTAL

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

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index \[BMI\] ≥25 kg/m2
  • Not having metal plates
  • Not studying Nutrition and Dietetics or Physical Education
  • Not being pregnant

You may not qualify if:

  • \- Presente gastrointestinal problems (vomit or diarrheas) during the three weeks that last the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Valparaíso, Región de Valparaíso, Chile

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 9, 2020

Study Start

August 28, 2017

Primary Completion

September 27, 2017

Study Completion

September 28, 2017

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

All participant data are private.

Locations