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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03001583
• Other study ID #: GRUCO_2016
• Status: Withdrawn
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: October 2021

Study information

• Verified date: February 2019
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		6 months
Secondary	Weight loss		Visits at 12, 18 and 24 months (to complete a total study time period of 24 months)