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
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
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
NCT ID
NCT05046626
First Posted
September 3, 2018
Last Updated
September 14, 2021
Sponsor
University of Guadalajara
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
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