NCT05046626

Brief Summary

This study evaluates the impact of changes in eating behavior through nutritional counseling, after nine months of intervention, on body composition and metabolism in adult workers with abdominal obesity

Trial Health

100
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2018

Completed
3 years until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

September 3, 2018

Last Update Submit

September 14, 2021

Conditions

Keywords

obesitynutritional counselingweight losseating behaviorsabdominal obesity

Outcome Measures

Primary Outcomes (1)

  • Change in eating behaviors

    Increase consumption and frequency of healthy foods such as water, fruits and vegetables, healthy fats and fish. Decrease consumption and frequency of fatty foods, processed foods and sweet drinks. Evaluated by the validated tool Mini-ECCA.

    6 and 9 months

Secondary Outcomes (2)

  • Anthropometric indicators

    6 and 9 months

  • Decrease triglycerides

    6 and 9 months

Study Arms (1)

nutritional counseling

EXPERIMENTAL

Arm with intervention

Other: Nutritional counseling

Interventions

Intervention based on nutritional counseling under Cognitive Behavioral Theory and the used of strategies like self-monitoring, goals, cognitive restructuring and social support.

nutritional counseling

Eligibility Criteria

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

You may qualify if:

  • With abdominal obesity: men with waist circumference (CC) ≥102 cm and women with CC ≥88 cm.
  • Literacy.
  • Sign the informed consent

You may not qualify if:

  • Participants with severe alterations of their renal function, hepatic, thyroid and circulatory system (self-reported or found in their laborarotorio analysis)
  • Participants with any serious illness, hospitalization in the 6 months prior to the start of the study.
  • In nutritional treatment for weight loss in the last three months.
  • In psychological and / or psychiatric treatment.
  • Depression or anxiety.
  • History of bariatric surgery.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, AbdominalObesityWeight LossFeeding Behavior

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Yolanda Fabiola Marquez Sandoval, PhD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 16, 2021

Study Start

April 4, 2016

Primary Completion

August 12, 2017

Study Completion

January 17, 2018

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

The investigators will share only the global results to the participants, and company and university authorities for decision making.