OverweightNCT05309044
Evaluation of the Planetary Health Diet Included in a Lifestyle Program in Overweight or Obese Mexican Adults.
A study testing Planetary Health Diet Group, Low-fat diet group and Waiting list group in people with Overweight and Obesity, run by Universidad de Sonora at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Planetary Health Diet Group, Low-fat diet group and Waiting list group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2022to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Promoción de Salud Nutricional (CPSN)
Hermosillo, Sonora, 83000
About this study
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.
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.
Read the 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
- Being tested
- Planetary Health Diet Group, Low-fat diet group, Waiting list group
- Keywords
- Lifestyle intervention, Weight loss, Diet, Planetary health
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planetary Health Diet GroupBehavioural
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 groupOther
This group includes a low-fat, low-calorie diet (1200-1800 kcal), in addition to a behavioral change protocol
Waiting list groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Planetary Health Diet Group | Active comparator | Diet proportional to the EAT-Lancet reference diet, in addition to a behavioral change protocol. Receives: Behavioral: Planetary Health Diet Group |
| Low-fat diet group | Active comparator | Low-fat, low-calorie diet and a behavioral change protocol Receives: Other: Low-fat diet group |
| Waiting list group | Placebo comparator | Waiting list group Receives: Other: Waiting list group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
To obtain weight (kg), a SECA mBCA model 514 digital scale will be used.
Measured: baseline and 4 months
Change in body fat
Kilograms of total body fat will be obtained by SECA mBCA model 514 digital scale.
Measured: baseline and 4 months
Secondary outcomes (6)
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.
Measured: baseline and 4 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Sonora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolando Giovanni Díaz Zavala, Universidad de Sonora
- Investigators
- Rolando G Diaz Zavala, Ph.D., Principal investigator, Universidad de Sonora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309044
- Sponsor's protocol ID
- DSP-ONLINE-MX
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The database and results of the study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05309044
- Acronym / sponsor ID
- DSP-ONLINE-MX
- Conditions
- Overweight, Obesity
- Keywords
- Lifestyle intervention, Weight loss, Diet, Planetary health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de SonoraUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Planetary Health Diet Group | Active comparator | Behavioral: Planetary Health Diet GroupDiet proportional to the EAT-Lancet reference diet, in addition to a behavioral change protocol. |
| Low-fat diet group | Active comparator | Other: Low-fat diet groupLow-fat, low-calorie diet and a behavioral change protocol |
| Waiting list group | Placebo comparator | Other: Waiting list groupWaiting list group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planetary Health Diet GroupThis 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). | Behavioural | Planetary Health Diet Group |
| Low-fat diet groupThis group includes a low-fat, low-calorie diet (1200-1800 kcal), in addition to a behavioral change protocol | Other | Low-fat diet group |
| Waiting list groupThis 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. | Other | Waiting list group |
Primary outcome
Change in body weight
Time frame: baseline and 4 months
To obtain weight (kg), a SECA mBCA model 514 digital scale will be used.
Change in body fat
Time frame: baseline and 4 months
Kilograms of total body fat will be obtained by SECA mBCA model 514 digital scale.
6 secondary outcomes
Change in waist circumference
Time frame: baseline and 4 months
Change in the Short Form-36 Health Survey score
Time frame: baseline and 4 months
Change in systolic and diastolic blood pressure
Time frame: baseline and 4 months
Adherence to intervention
Time frame: up to 16 weeks
Retention / desertion
Time frame: 4 months
Change in body mass index
Time frame: baseline and 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: Yes. The database and results of the study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolando G Diaz Zavala, Ph.D. principal investigator
Universidad de Sonora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planetary Health Diet Group, Low-fat diet group and Waiting list group in people with Overweight and Obesity, run by Universidad de Sonora at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolando G Diaz Zavala, Ph.D. (6622893793 ext. 4632, giovanni.diaz@unison.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: baseline and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.