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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2021-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Education program with cooking lessons

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Education program WITHOUT cooking lessons

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No