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

NCT05309044 | Unknown

• 1 other identifier: DSP-ONLINE-MX
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Overweight; Obesity

Keywords

Lifestyle intervention; Weight loss; Diet; Planetary health

Outcome Measures

Primary Outcomes (2)

• Change in body weight

  To obtain weight (kg), a SECA mBCA model 514 digital scale will be used.

  baseline and 4 months

• Change in body fat

  Kilograms of total body fat will be obtained by SECA mBCA model 514 digital scale.

  baseline and 4 months

Secondary Outcomes (6)

• Change in waist circumference

  baseline and 4 months

• Change in the Short Form-36 Health Survey score

  baseline and 4 months

• Change in systolic and diastolic blood pressure

  baseline and 4 months

• Adherence to intervention

  up to 16 weeks

• Retention / desertion

  4 months

Study Arms (3)

Planetary Health Diet Group

ACTIVE COMPARATOR

Diet proportional to the EAT-Lancet reference diet, in addition to a behavioral change protocol.

Behavioral: Planetary Health Diet Group

Low-fat diet group

ACTIVE COMPARATOR

Low-fat, low-calorie diet and a behavioral change protocol

Other: Low-fat diet group

Waiting list group

PLACEBO COMPARATOR

Waiting list group

Other: Waiting list group

Interventions

Planetary Health Diet Group BEHAVIORAL

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).

Planetary Health Diet Group

Low-fat diet group OTHER

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

Low-fat diet group

Waiting list group OTHER

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.

Waiting list group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mexican adults (≥18 and ≤60 years).
• Residents of the city of Hermosillo, Sonora.
• BMI ≥ 25 kg/m2 and ≤ 40 kg/m2.
• Availability of time to participate in the study
• Have an electronic device with internet access
• Completion of a dietary record for at least 2 days prior to the intervention.
• Active Facebook account, telephone number, WhatsApp and/or e-mail address
• Basic computer skills

You may not qualify if:

• Illiteracy
• Present health conditions due to previous diagnosis with effect on body weight, or that prevent adherence to the intervention (Diabetes, hypertension with values ≥ 150/95 mm Hg, liver failure)
• Pregnancy or lactation.
• History of weight loss in the last 4 months of \> 5% of total body weight.
• Being 10% below usual weight.
• Surgeries aimed at weight and/or body fat reduction.
• Use of medications or substances with effect on body weight, e.g. metformin, orlistat, corticosteroids, etc.
• Use of addictive substances
• Plan to change residence during the 4 months of the study.
• Other family member who has agreed to participate in the study.
• History of COVID-19 that required hospitalization or needed for supplemental oxygen or developed sequelae that precludes intervention.

Sponsors & Collaborators

• Universidad de Sonora: lead

Study Sites (1)

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, 83000, Mexico

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Rolando G Diaz Zavala, Ph.D.

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rolando G Diaz Zavala, Ph.D.

CONTACT

6622893793; giovanni.diaz@unison.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Undefined
• Access Criteria: Direct communication with the corresponding authors.

Locations

ME (1)