ClinicalTrials.gg
CompletedNCT04463407Updated Jul 28, 2026

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

An interventional study of Educational talk about physical activity and nutritional recommendations before a critical period of fat gain in university students in Obesity, sponsored by Pontificia Universidad Catolica de Valparaiso. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Pontificia Universidad Catolica de Valparaiso · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Aug 2017, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

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03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 36 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Pontificia Universidad Catolica de Valparaiso is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • 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.

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

Interventions

  • OtherEducational 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.

06

What researchers measure

Primary outcomes

  1. Body composition measurements

    Changes on fat mass measured by Dual X-ray Absorptiometry (DXA)

    Time frame: 3 weeks

Secondary outcomes

  1. Feeding questionnaires and food guide recommendations

    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.

    Time frame: 3 weeks

  2. Feeding questionnaires and food guide recommendations

    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.

    Time frame: 3 weeks

  3. Feeding questionnaires and food guide recommendations

    Changes on the Food Guide Recommendation

    Time frame: 3 weeks

  4. Physical activity level

    Modification on physical activity level measured by accelerometry

    Time frame: 3 weeks

07

Study locations

1 site
  • School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
    Valparaíso, Valparaiso, Chile
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — All participant data are private.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Sep 2017, 0 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 0 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2020
First posted
Jul 9, 2020
StartActual
Aug 28, 2017
Primary completionActual
Sep 27, 2017
CompletionActual
Sep 28, 2017
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04463407
Lead sponsor
Pontificia Universidad Catolica de Valparaiso
Responsible party
Carlos Cristi Montero (Principal Investigator, Pontificia Universidad Catolica de Valparaiso) — Principal investigator
First posted
Jul 9, 2020
Start date
Aug 28, 2017
Primary completion
Sep 27, 2017
Completion
Sep 28, 2017
Last update
Jul 28, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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