Study Stopped
The investigators hadn't got funding to support the study
Clinical Trial Comparing Two Health Education Programs for Obese Patients (HEPO-TRIAL)
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
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Started Oct 2019
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedStudy Start
First participant enrolled
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedFebruary 6, 2020
February 1, 2019
1.9 years
December 7, 2016
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss
6 months
Secondary Outcomes (1)
Weight loss
Visits at 12, 18 and 24 months (to complete a total study time period of 24 months)
Study Arms (2)
Education Program with cooking lessons
EXPERIMENTALStructured 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.
Education without cooking
ACTIVE COMPARATORStructured 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Obese patients attending our center
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2016
First Posted
December 23, 2016
Study Start
October 30, 2019
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
February 6, 2020
Record last verified: 2019-02