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Evaluation of the Planetary Health Diet Included in a Lifestyle Program in Overweight or Obese Mexican Adults.

NCT05309044 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-28

No results posted yet for this study

Summary

The EAT-Lancet Commission proposed the planetary health diet as a strategy to achieve health and sustainability goals. Currently, its effect in the treatment of obesity has not been evaluated. The main aim is to evaluate the efficacy of the planetary health diet included in an intensive lifestyle change program compared to a waiting list group, on weight and body fat at 4 months, in Mexican adults with overweight or obesity, in an online modality. This study is a 4-month randomized controlled trial, in an online modality in individuals with overweight or obesity randomly assigned 1:1:1 to one of three groups: 1) planetary health diet, 2) waiting list and 3) low fat-diet. The primary outcome is the difference in change in weight (kg) and body fat (kg) at 4 months between the planetary health diet group and the waiting list group. Comparison with the low-fat diet group will be an exploratory analysis. Secondary variables include changes in waist circumference, BMI, blood pressure, and health-related quality of life. Between group comparisons will be analyzed by intention-to-treat. The protocol was approved by a Research Bioethics Committee.

Conditions

Interventions

BEHAVIORAL

Planetary Health Diet Group

This group includes a diet proportional to the EAT-Lancet reference diet (2500 kcal), with a caloric intake of 1200 to 1800 kcal, in addition to a behavioral change protocol during the time of the study (4 months).

OTHER

Low-fat diet group

This group includes a low-fat, low-calorie diet (1200-1800 kcal), in addition to a behavioral change protocol

OTHER

Waiting list group

This group will only receive digital information with recommendations on healthy eating. When the study has finished, this group will receive a behavioral change protocol with a low-fat, low-calorie diet.

Sponsors & Collaborators

  • Universidad de Sonora

    lead OTHER

Principal Investigators

  • Rolando G Diaz Zavala, Ph.D. · Universidad de Sonora

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309044 on ClinicalTrials.gov