Clinical Trial Comparing Two Health Education Programs for Obese Patients (HEPO-TRIAL)

February 4, 2020 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Clinical Trial Comparing Two Health Education Programs for Obese Patients: Groups With Health Education Plus Cooking Program vs. Only Education Without Cooking

Clinical trial comparing two health education programs for obese patients in order to achieve a substantial and beneficial weight loss, using mediterranean diet. Patients will be allocated to two groups, one will receive education in diet and lifestyle, and the other one the same plus cooking lessons. The intervention period is for 6 months with monthly visits and phone and email contacts in between. An extension observation period of two years is also planned with 6 months contacts in our clinic, also with phone and email contact available.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Eligibility: obese patients attending our center. Exclusion criteria: previous dietary or anti-obesity drugs treatments, previous bariatric surgery, eating disorders, desire for short-term bariatric surgery, active neoplasia, end stage kidney or liver disease, food allergies or celiac disease.

Sample Size: a total of 260 patients (130 patients in each group) are needed for α=0.05 and 1-ß=0.8, to reach a difference of a 5% in weight loss between both groups, with a maximum of a 30% dropouts.

Intervention: structured health education program of Mediterranean diet and lifestyle changes with cooking lessons in monthly sessions, with the aid of phone and email contacts during an induction phase of 6 months, followed by an extension period of 18 months.

Control: same strategy without the cooking lessons. Primary outcome: weight loss in % Secondary outcomes: reversal in obesity associated comorbidities and quality of life.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese patients attending our center

Exclusion Criteria:

  • Previous dietary or pharmacologic treatment for obesity, previous bariatric surgery, desired bariatric surgery in the short-term, eating disorders, end-stage kidney or liver disease, active neoplasia, food allergies, celiac disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education Program with cooking lessons
Structured education program of mediterranean diet and lifestyle changes with cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
Behavioral: Education program with cooking lessons
Structured education program of mediterranean diet and lifestyle changes with cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
Active Comparator: Education without cooking
Structured education program of mediterranean diet and lifestyle changes WITHOUT cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
Behavioral: Education program WITHOUT cooking lessons
Structured education program of mediterranean diet and lifestyle changes WITHOUT cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: Visits at 12, 18 and 24 months (to complete a total study time period of 24 months)
Visits at 12, 18 and 24 months (to complete a total study time period of 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 23, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GRUCO_2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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