Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Overweight and Obesity (PASO diet)
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|ClinicalTrials.gov Identifier: NCT03608176|
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : April 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Other: PASO diet group Other: Low-fat diet group Other: Waiting list group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy of Plant-based Approaches to Stop Obesity Diet in Comparison With a Control Group on Body Weight in Mexican Adults With Overweight and Obesity: Randomized Controlled Trial|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
|Experimental: PASO diet group||
Other: PASO diet group
This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol. They will also be instructed to consume green tea (2 cups/day for 3 days/week), black tea (2 cups/day for 2 days/week), coffee (2 cups/day for 2 days/week), cinnamon (1 tsp/day for at least 3 days/week), psyllium fiber (3 tsp/day/week) and water (1.5 L/day/week).
|Active Comparator: Low-fat diet group||
Other: Low-fat diet group
This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol.
|Waiting list group||
Other: Waiting list group
This group will only receive written information with recommendations on healthy eating. When the study finished, this group will receive a behavioral change protocol with a low-fat, low calorie diet.
- Change in body weight [ Time Frame: baseline to 3 months ]
- Change in waist circumference [ Time Frame: baseline to 3 months ]
- Change in body fat percentage [ Time Frame: baseline to 3 months ]
- Change in the Beck Depression Inventory score [ Time Frame: baseline to 3 months ]The Beck Depression Inventory (BDI) is a 21-item questionnaire that assesses mood over the previous week. Total scores range from 0 to 63, with higher values indicating greater symptoms of depression. Scores of 0-9 reflect minimal (subclinical) symptoms, values of 10-18, 19-29, and ≥30 indicate mild, moderate, and severe symptoms of depression, respectively.
- Change in the Short Form-36 Health Survey score [ Time Frame: baseline to 3 months ]The SF-36 Health Survey evaluates aspects of the quality of life in adult populations (over 16 years of age). The result of its application is the generation of eight concepts or scales of health, result of the average of the sum of the questions contained in the questionnaire for each concept. These concepts are: physical function, physical role, corporal pain, general health, vitality, social function, emotional role and mental health. The SF-36 is a self-applied instrument and contains 36 questions. For each scale, the answers to each question are coded and recoded (10 questions), and the results are interpreted on a scale of 0 to 100, lower results indicate poorer health and greater result better health).
- Change in systolic and diastolic blood pressure [ Time Frame: baseline to 3 months ]
- Change in fasting glucose [ Time Frame: baseline to 3 months ]
- Change in total cholesterol [ Time Frame: baseline to 3 months ]
- Change in LDL-cholesterol [ Time Frame: baseline to 3 months ]
- Change in HDL-cholesterol [ Time Frame: baseline to 3 months ]
- Change in triglycerides [ Time Frame: baseline to 3 months ]
- Change in gamma glutamyl transferase [ Time Frame: baseline to 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608176
|Contact: Rolando G Díaz Zavala, Ph.D.||6622893793 ext firstname.lastname@example.org|
|Centro de Promoción de Salud Nutricional (CPSN)||Recruiting|
|Hermosillo, Sonora, Mexico, 83000|
|Contact: Rolando Giovanni Díaz Zavala, Ph.D. 6622893793 ext 4632 email@example.com|
|Principal Investigator: Rolando Giovanni Díaz Zavala, Ph.D.|
|Principal Investigator:||Rolando G Díaz Zavala, Ph.D.||Universidad de Sonora|