Obesity, AbdominalNCT05046626
Nutritional Counseling to Change Eating Behavior, Metabolism and Anthropometry in Adults With Abdominal Obesity
A study testing Nutritional counseling in people with Obesity, Abdominal, run by University of Guadalajara.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Nutritional counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2016to 17 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- With abdominal obesity: men with waist circumference (CC) ≥102 cm and women with CC ≥88 cm.
- Literacy.
- Sign the informed consent
Who cannot join
- 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.
About this study
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
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
Read the 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.
- Conditions
- Obesity, Abdominal
- Being tested
- Nutritional counseling
- Keywords
- obesity, nutritional counseling, weight loss, eating behaviors, abdominal obesity
- Medical subject headings
- Obesity, Abdominal, Obesity, Weight Loss, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional counselingOther
Intervention based on nutritional counseling under Cognitive Behavioral Theory and the used of strategies like self-monitoring, goals, cognitive restructuring and social support.
| Study group | Role | What they receive |
|---|---|---|
| nutritional counseling | Experimental | Arm with intervention Receives: Other: Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 and 9 months
Secondary outcomes (2)
Anthropometric indicators
Decrease waist circumference
Measured: 6 and 9 months
Decrease triglycerides
Decrease serum values of triglycerides
Measured: 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start4 Apr 2016
- Primary completion12 Aug 2017
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yolanda Fabiola Márquez Sandoval, University of Guadalajara
- Investigators
- Yolanda Fabiola Marquez Sandoval, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046626
- Sponsor's protocol ID
- Universidad de Guadalajara
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2018
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will share only the global results to the participants, and company and university authorities for decision making.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05046626
- Acronym / sponsor ID
- Universidad de Guadalajara
- Conditions
- Obesity, Abdominal
- Keywords
- obesity, nutritional counseling, weight loss, eating behaviors, abdominal obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nutritional counseling | Experimental | Other: Nutritional counselingArm with intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With abdominal obesity: men with waist circumference (CC) ≥102 cm and women with CC ≥88 cm.
- Literacy.
- Sign the informed consent
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional counselingIntervention based on nutritional counseling under Cognitive Behavioral Theory and the used of strategies like self-monitoring, goals, cognitive restructuring and social support. | Other | nutritional counseling |
Primary outcome
Change in eating behaviors
Time frame: 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.
2 secondary outcomes
Anthropometric indicators
Time frame: 6 and 9 months
Decrease triglycerides
Time frame: 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No. The investigators will share only the global results to the participants, and company and university authorities for decision making.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda Fabiola Marquez Sandoval, PhD principal investigator
University of Guadalajara
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional counseling in people with Obesity, Abdominal, run by University of Guadalajara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eating behaviors (time frame: 6 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.