Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Consuming "Home Meals" on Body Weight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653559
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Laguna Camacho, Universidad Autonoma del Estado de Mexico

Brief 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. 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".

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Home meals Behavioral: Healthy meals Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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: Single (Participant)
Masking Description: Participants are only aware of the study condition in which they are allocated.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in weight and body fat [ Time Frame: Every four weeks during 12 weeks ]
    Amount of weight/fat gained or lost during the intervention


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI of 25 kg/m2 or above

Exclusion Criteria:

  • Presence of chronic disease

Information from the National Library of Medicine

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


Locations
Layout table for location information
Mexico
Centro de Investigación en Ciencias Médicas
Toluca, Mexico, 50130
Sponsors and Collaborators
Universidad Autonoma del Estado de Mexico
Investigators
Layout table for investigator information
Principal Investigator: Antonio Laguna Camacho, PhD Universidad Autónoma del Estado de Mexico

Layout table for additonal information
Responsible Party: Antonio Laguna Camacho, Full-time Professor, Universidad Autonoma del Estado de Mexico
ClinicalTrials.gov Identifier: NCT03653559    
Other Study ID Numbers: 15CI1506014
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms