Overweight and ObesityNCT03653559
Effect of Consuming "Home Meals" on Body Weight
A study testing Home meals and Healthy meals in people with Overweight and Obesity, run by Universidad Autonoma del Estado de Mexico at 1 site in Mexico.
Trial summary
The current epidemic of obesity relates to the transition from traditional to industrialised diets. The present project investigates the effect on body energy of recommending the consumption of traditional "home meals", which may be a useful recommendation against obesity. Read more about this study
- Who is it for?
- Ages 18 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Home meals and Healthy meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jan 2018to 30 Jun 2019
- 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 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 25 kg/m2 or above
Who cannot join
- Presence of chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Weight and Adiposity of "Home Meals" in Women With Overweight or Obesity
The current epidemic of obesity relates to the transition from traditional to industrialised diets. The present project investigates the effect on body energy of recommending the consumption of traditional "home meals", which may be a useful recommendation against obesity. A randomized controlled trial design is applied assigning participants to a recommendation of consuming during 12 weeks either "home meals" or "healthy meals." Frequency of consumption of energy-dense foods and of exercise is monitored throughout the intervention; weight and body fat are measured at baseline and at four-week intervals. The hypothesis is that consuming more frequently "home meals" reduces at least as much weight and adiposity as "healthy meals".
Read the detailed description
Obesity is a global health problem that requires effective intervention. In Mexico, 2 out of 3 adults are classed as overweight or obese. Weight gain from frequent consumption of energy dense food impairs the metabolism of lipids and glucose which causes the inflammatory state that underlies development of chronic illnesses such as cardiovascular disease. Mexican women with overweight or obesity consume on average 12 times per week food rich in sugar or fat. This indicates a high prevalence of unhealthy eating habits.
Such unhealthy habits are however determined by the modern environment. The raise in food availability is associated with increase in body weight at population level. Diverse studies indicate also an increase in the number of fast food outlets together with an increase in the frequency of eating out of the home. Therefore, people are exposed to abundance of unhealthy food that leads to acquire the habit of consuming them.
The informative education on "healthy" eating is a main intervention to abate obesity levels in the population. However, the prevalence of overweight and obesity is still increasing. In fact, if this trend continues, in 2025, 32 million of Mexican adults will achieve the diagnosis of obesity.
New perspectives for intervention are needed against obesity. We propose "home meals" as a novel strategy to enhance the effectivity of educative messages on "healthy" eating that generally presents food out of their cultural context. Our definition of "home meal" considers not only the physical space where foods are consumed but also a typical socially accepted preparation based on local foods. This proposal about "home meals" is partly made because the raise of obesity in the population coincides with the replacement of traditional diet by consumption of industrialised unhealthy food.
The present project develops an intervention that compares "home meals" vs. "healthy meals" with regards to their effect on weight and body fat. The aim is to test if the recommendation of eating "home meals" has a slimming effect and how it compares to that of the standard isocaloric recommendation of eating "healthy meals." The hypothesis is that because "home meals" are culturally tailored, they would be easier to practice, and so a similar weight/body fat loss to the "healthy meals" would be at least achieved.
- Conditions
- Overweight and Obesity
- Being tested
- Home meals, Healthy meals
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home mealsBehavioural
Adult participants with overweight or obesity are asked to consume "home meals" during 12 weeks.
Healthy mealsBehavioural
Adult participants with overweight or obesity are asked to consume "healthy meals" during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| "Home meals" condition | Experimental | The recommendation consists of menus with examples of breakfast, lunch and dinner based on typical preparations plus a prescription of the number of portions of the food groups that provides 1200 kcal with a distribution of 50-60% carbohydrates, 15-20% protein and < 30% lipids. Receives: Behavioral: Home meals |
| "Healthy meals" condition | Active comparator | The recommendation consists of the educative graphic tool "Eatwell plate" plus a prescription of the same number of portions of the food groups for a isocaloric diet with the same macronutrient distribution as the "home meals" condition. Receives: Behavioral: Healthy meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight and body fat
Amount of weight/fat gained or lost during the intervention
Measured: Every four weeks during 12 weeks
Secondary outcomes (1)
Change in frequency of consumption of energy-dense foods or of exercise
Change in number of times a week in which participants consumed energy dense foods or exercised relative to their baseline levels
Measured: Every four weeks during 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start15 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Model description
- Randomised controlled trial. The model tests a new dietary recommendation ("home meals" condition) against a standard dietary recommendation ("healthy meals" condition)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma del Estado de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Laguna Camacho, Universidad Autonoma del Estado de Mexico
- Investigators
- Antonio Laguna Camacho, PhD, Principal investigator, Universidad Autónoma del Estado de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653559
- Sponsor's protocol ID
- 15CI1506014
- Status last verified
- Nov 2020
- First submitted
- 9 Aug 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Materials and dataset is available in the OSF platform
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Weight and Adiposity of "Home Meals" in Women With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT03653559
- Acronym / sponsor ID
- 15CI1506014
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Autonoma del Estado de MexicoUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 31 Aug 2018 (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 current epidemic of obesity relates to the transition from traditional to industrialised diets. The present project investigates the effect on body energy of recommending the consumption of traditional "home meals", which may be a useful recommendation against obesity. A randomized controlled trial design is applied assigning participants to a recommendation of consuming during 12 weeks either "home meals" or "healthy meals." Frequency of consumption of energy-dense foods and of exercise is monitored throughout the intervention; weight and body fat are measured at baseline and at four-week intervals. The hypothesis is that consuming more frequently "home meals" reduces at least as much weight and adiposity as "healthy meals".
Detailed description
Obesity is a global health problem that requires effective intervention. In Mexico, 2 out of 3 adults are classed as overweight or obese. Weight gain from frequent consumption of energy dense food impairs the metabolism of lipids and glucose which causes the inflammatory state that underlies development of chronic illnesses such as cardiovascular disease. Mexican women with overweight or obesity consume on average 12 times per week food rich in sugar or fat. This indicates a high prevalence of unhealthy eating habits.
Such unhealthy habits are however determined by the modern environment. The raise in food availability is associated with increase in body weight at population level. Diverse studies indicate also an increase in the number of fast food outlets together with an increase in the frequency of eating out of the home. Therefore, people are exposed to abundance of unhealthy food that leads to acquire the habit of consuming them.
The informative education on "healthy" eating is a main intervention to abate obesity levels in the population. However, the prevalence of overweight and obesity is still increasing. In fact, if this trend continues, in 2025, 32 million of Mexican adults will achieve the diagnosis of obesity.
New perspectives for intervention are needed against obesity. We propose "home meals" as a novel strategy to enhance the effectivity of educative messages on "healthy" eating that generally presents food out of their cultural context. Our definition of "home meal" considers not only the physical space where foods are consumed but also a typical socially accepted preparation based on local foods. This proposal about "home meals" is partly made because the raise of obesity in the population coincides with the replacement of traditional diet by consumption of industrialised unhealthy food.
The present project develops an intervention that compares "home meals" vs. "healthy meals" with regards to their effect on weight and body fat. The aim is to test if the recommendation of eating "home meals" has a slimming effect and how it compares to that of the standard isocaloric recommendation of eating "healthy meals." The hypothesis is that because "home meals" are culturally tailored, they would be easier to practice, and so a similar weight/body fat loss to the "healthy meals" would be at least achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled trial. The model tests a new dietary recommendation ("home meals" condition) against a standard dietary recommendation ("healthy meals" condition)
| Arm | Type | Receives |
|---|---|---|
| "Home meals" condition | Experimental | Behavioral: Home mealsThe recommendation consists of menus with examples of breakfast, lunch and dinner based on typical preparations plus a prescription of the number of portions of the food groups that provides 1200 kcal with a distribution of 50-60% carbohydrates, 15-20% protein and < 30% lipids. |
| "Healthy meals" condition | Active comparator | Behavioral: Healthy mealsThe recommendation consists of the educative graphic tool "Eatwell plate" plus a prescription of the same number of portions of the food groups for a isocaloric diet with the same macronutrient distribution as the "home meals" condition. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI of 25 kg/m2 or above
Key exclusion criteria (1 listed)
- Presence of chronic disease
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 |
|---|---|---|
| Home mealsAdult participants with overweight or obesity are asked to consume "home meals" during 12 weeks. | Behavioural | "Home meals" condition |
| Healthy mealsAdult participants with overweight or obesity are asked to consume "healthy meals" during 12 weeks. | Behavioural | "Healthy meals" condition |
Primary outcome
Change in weight and body fat
Time frame: Every four weeks during 12 weeks
Amount of weight/fat gained or lost during the intervention
1 secondary outcome
Change in frequency of consumption of energy-dense foods or of exercise
Time frame: Every four weeks during 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: Yes. Materials and dataset is available in the OSF platform
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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.
Antonio Laguna Camacho, PhD principal investigator
Universidad Autónoma del Estado de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home meals and Healthy meals in people with Overweight and Obesity, run by Universidad Autonoma del Estado de Mexico 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Nov 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight and body fat (time frame: Every four weeks during 12 weeks). 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 4 Nov 2020.