NCT05309044

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

Evaluation of the Efficacy of the Planetary Health Diet Included in an Intensive Lifestyle Change Program on Weight and Body Fat at 4 Months in Mexican Adults With Overweight or Obesity in an Online Modality: Randomized Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universidad de Sonora · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2022-04-04
• Last updated: 2022-04-28

Locations

1 site across 1 country: Mexico