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

NCT ID: NCT05309044

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2022-08-31

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.

Detailed Description

The present study is a randomized controlled trial of parallel groups and superiority. The sample will consist of 60 participants (20 participants for each arm of the study), calculated from previous studies of our research group. The intervention groups will be 1) planetary health diet, 2) waiting list group, and 3) low-fat diet.

Participants will be measured at the start of the study and at 4 months. The participants of the two diets will follow the Diabetes Prevention Program (DPP) adapted to the Mexican population and its online application. It has also been adapted for the planetary health diet group.

Participants will receive 13 online group educational sessions over 4 months (1 per week) and at least one individual session per week. They will receive a meal plan according to the dietary group to which they belong, with a calorie range from 1200 to 1800 kcal.

Participants in the waiting list group will receive digital information on healthy eating. Upon completion of the study, they will be invited to participate in the "Lifestyle Balance Program" offered at the Nutritional Health Promotion Center, which is an adaptation of the DPP. During the 4 months, there won't be any contact with this group.

The analysis of the primary and secondary outcomes will be carried out in a conservative way by intention to treat and also by completers analysis.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Planetary Health Diet Group

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

Group Type: ACTIVE_COMPARATOR

Planetary Health Diet Group

Intervention Type: 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).

Low-fat diet group

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

Group Type: ACTIVE_COMPARATOR

Low-fat diet group

Intervention Type: OTHER

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

Waiting list group

Waiting list group

Group Type: PLACEBO_COMPARATOR

Waiting list group

Intervention Type: 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.

Interventions

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).

Intervention Type: BEHAVIORAL

Low-fat diet group

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Sonora

OTHER

Sponsor Role: lead

Responsible Party

Rolando Giovanni Díaz Zavala

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolando G Diaz Zavala, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Sonora

Locations

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, Mexico

Countries

Mexico

Central Contacts

Rolando G Diaz Zavala, Ph.D.

Role: CONTACT

giovanni.diaz@unison.mx

6622893793 ext. 4632

Other Identifiers

DSP-ONLINE-MX

Identifier Type: -

Identifier Source: org_study_id