Effect of Consuming "Home Meals" on Body Weight
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|ClinicalTrials.gov Identifier: NCT03653559|
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : September 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Behavioral: Home meals Behavioral: Healthy meals||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised controlled trial. The model tests a new dietary recommendation ("home meals" condition) against a standard dietary recommendation ("healthy meals" condition)|
|Masking Description:||Participants are only aware of the study condition in which they are allocated.|
|Official Title:||Effect on Weight and Adiposity of "Home Meals" in Women With Overweight or Obesity|
|Actual Study Start Date :||January 15, 2018|
|Actual Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: "Home meals" condition
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.
Behavioral: Home meals
Adult participants with overweight or obesity are asked to consume "home meals" during 12 weeks.
Active Comparator: "Healthy meals" condition
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.
Behavioral: Healthy meals
Adult participants with overweight or obesity are asked to consume "healthy meals" during 12 weeks.
- Change in weight and body fat [ Time Frame: Every four weeks during 12 weeks ]Amount of weight/fat gained or lost during the intervention
- Change in frequency of consumption of energy-dense foods or of exercise [ Time Frame: Every four weeks during 12 weeks ]Change in number of times a week in which participants consumed energy dense foods or exercised relative to their baseline levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653559
|Centro de Investigación en Ciencias Médicas|
|Toluca, Mexico, 50130|
|Principal Investigator:||Antonio Laguna Camacho, PhD||Universidad Autónoma del Estado de Mexico|