Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Planetary Health Diet Group | Active Comparator | Diet proportional to the EAT-Lancet reference diet, in addition to a behavioral change protocol. |
|
| Low-fat diet group | Active Comparator | Low-fat, low-calorie diet and a behavioral change protocol |
|
| Waiting list group | Placebo Comparator | Waiting list group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in the Short Form-36 Health Survey score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rolando G Diaz Zavala, Ph.D. | Contact | 6622893793 | 4632 | giovanni.diaz@unison.mx |
| Name | Affiliation | Role |
|---|---|---|
| Rolando G Diaz Zavala, Ph.D. | Universidad de Sonora | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Promoción de Salud Nutricional (CPSN) | Hermosillo | Sonora | 83000 | Mexico |
The database and results of the study are available from the corresponding author on reasonable request.
Undefined
Direct communication with the corresponding authors.
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low-fat diet group | Other | This group includes a low-fat, low-calorie diet (1200-1800 kcal), in addition to a behavioral change protocol |
|
| 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. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |