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

Sponsor

University of Guadalajara (Other)

Overall Status

Completed

CT.gov ID

NCT05046626

Collaborator

(none)

113

Enrollment

Arm

21.5

Actual Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Obesity, Abdominal	Other: Nutritional counseling	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Apr 4, 2016

Actual Primary Completion Date :

Aug 12, 2017

Actual Study Completion Date :

Jan 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nutritional counseling Arm with intervention	Other: Nutritional counseling Intervention based on nutritional counseling under Cognitive Behavioral Theory and the used of strategies like self-monitoring, goals, cognitive restructuring and social support.

Arm

Intervention/Treatment

Experimental: nutritional counseling

Arm with intervention

Other: Nutritional counseling

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

Outcome Measures

Primary Outcome Measures

Change in eating behaviors [6 and 9 months]
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 [6 and 9 months]
Decrease waist circumference
Decrease triglycerides [6 and 9 months]
Decrease serum values of triglycerides

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.