search
Back to results

Nutritional Counseling to Change Eating Behavior, Metabolism and Anthropometry in Adults With Abdominal Obesity

Primary Purpose

Obesity, Abdominal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional counseling
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity, Abdominal focused on measuring obesity, nutritional counseling, weight loss, eating behaviors, abdominal obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    nutritional counseling

    Arm Description

    Arm with intervention

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Anthropometric indicators
    Decrease waist circumference
    Decrease triglycerides
    Decrease serum values of triglycerides

    Full Information

    First Posted
    September 3, 2018
    Last Updated
    September 14, 2021
    Sponsor
    University of Guadalajara
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05046626
    Brief Title
    Nutritional Counseling to Change Eating Behavior, Metabolism and Anthropometry in Adults With Abdominal Obesity
    Official Title
    Effect of Intervention Based on Nutritional Counseling on Changes in Eating Behavior and Components of Body Composition and Metabolism in Adult Workers With Abdominal Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 4, 2016 (Actual)
    Primary Completion Date
    August 12, 2017 (Actual)
    Study Completion Date
    January 17, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Guadalajara

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    Detailed Description
    This study is a nutritional intervention in voluntary workers with abdominal obesity (waist circumference ≥102cm and ≥88cm). The intervention is divided into two phases: the intensive one has a duration of 6 months and consisted in a 4 face-to-face sessions with 9 online or telephone contacts based on the use of nutritional counseling [Academy of Nutrition and Dietetics, 2013] and the second phase: consisted in a 3 months' follow-up with 2 telephone contacts and a final visit face-to-face. The investigators used the Cognitive Behavior Therapy process as a theoretical framework, and also used the intervention comprised sessions designed to promote motivation, social support, self-regulation to promote the eating behavior change process. The participants were measured weight loss, waist circumference, and the lipid profile change, pre-intervention, and after six and nice months post-intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Abdominal
    Keywords
    obesity, nutritional counseling, weight loss, eating behaviors, abdominal obesity

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    113 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    nutritional counseling
    Arm Type
    Experimental
    Arm Description
    Arm with intervention
    Intervention Type
    Other
    Intervention Name(s)
    Nutritional counseling
    Intervention Description
    Intervention based on nutritional counseling under Cognitive Behavioral Theory and the used of strategies like self-monitoring, goals, cognitive restructuring and social support.
    Primary Outcome Measure Information:
    Title
    Change in eating behaviors
    Description
    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.
    Time Frame
    6 and 9 months
    Secondary Outcome Measure Information:
    Title
    Anthropometric indicators
    Description
    Decrease waist circumference
    Time Frame
    6 and 9 months
    Title
    Decrease triglycerides
    Description
    Decrease serum values of triglycerides
    Time Frame
    6 and 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: With abdominal obesity: men with waist circumference (CC) ≥102 cm and women with CC ≥88 cm. Literacy. Sign the informed consent Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yolanda Fabiola Marquez Sandoval, PhD
    Organizational Affiliation
    University of Guadalajara
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The investigators will share only the global results to the participants, and company and university authorities for decision making.

    Learn more about this trial

    Nutritional Counseling to Change Eating Behavior, Metabolism and Anthropometry in Adults With Abdominal Obesity

    We'll reach out to this number within 24 hrs