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

Obesity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05309044
• Other study ID #: DSP-ONLINE-MX
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: August 2022

Study information

• Verified date: April 2022
• Source: Universidad de Sonora
• Contact: Rolando G Diaz Zavala, Ph.D.
• Phone: 6622893793
• Email: giovanni.diaz[@]unison.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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
• 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.

Locations

Country	Name	City	State
Mexico	Centro de Promoción de Salud Nutricional (CPSN)	Hermosillo	Sonora

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Sonora

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	To obtain weight (kg), a SECA mBCA model 514 digital scale will be used.	baseline and 4 months
Primary	Change in body fat	Kilograms of total body fat will be obtained by SECA mBCA model 514 digital scale.	baseline and 4 months
Secondary	Change in waist circumference	The umbilical scar will be taken as reference and a Lufkin metallic anthropometric tape (Lufkin Executive. Thinline with scale from 0 to 200 cm. Model: W606PMMX) will be used.	baseline and 4 months
Secondary	Change in the Short Form-36 Health Survey score	The SF-36 Health Survey evaluates dimensions of health-related quality of life in the adult population (over 16 years of age). It should preferably be self-administered, and it provides eight scales or concepts related to disease and treatment. These scales are: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health. The SF-36 Health Survey consists of 36 questions (items) that assess both positive and negative health status. The answers to each question are coded and decoded (10 questions), and the result is interpreted on a scale from 0 to 100.	baseline and 4 months
Secondary	Change in systolic and diastolic blood pressure	Blood pressure will be measured using an Omron digital blood pressure monitor (model HEM-907XL, Omron Healthcare Co., Ltd, USA). The technique for obtaining blood pressure will be that proposed by the International Society of Hypertension. Three measurements will be taken at 1-minute intervals, and the mean of the last 2 measurements will be used.	baseline and 4 months
Secondary	Adherence to intervention	To measure adherence to the interventions, a numerical self-assessment scale from 1 to 5 will be used, where 1 is the lowest score and 5 is the highest, to indicate how adherent they were to the meal plans.	up to 16 weeks
Secondary	Retention / desertion	The retention percentage will be obtained by dividing the number of people that finished the intervention (i.e. participated in the measurements at 4 months) by the number that started the intervention, multiplied by 100. The dropout percentage will be obtained by the difference in the number of subjects who started and finished the intervention, multiplied by 100.	4 months
Secondary	Change in body mass index	body mass index is obtained by dividing the weight in kg by the height in meters squared and will be classified in different global BMI cut-off points for adults	baseline and 4 months