Effect of Consuming "Home Meals" on Body Weight
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Home meals
Healthy meals
Sponsored by

About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI of 25 kg/m2 or above
Exclusion Criteria:
- Presence of chronic disease
Sites / Locations
- Centro de Investigación en Ciencias Médicas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
"Home meals" condition
"Healthy meals" condition
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in weight and body fat
Amount of weight/fat gained or lost during the intervention
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03653559
First Posted
August 9, 2018
Last Updated
November 2, 2020
Sponsor
Universidad Autonoma del Estado de Mexico
1. Study Identification
Unique Protocol Identification Number
NCT03653559
Brief Title
Effect of Consuming "Home Meals" on Body Weight
Official Title
Effect on Weight and Adiposity of "Home Meals" in Women With Overweight or Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma del Estado de Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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".
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial. The model tests a new dietary recommendation ("home meals" condition) against a standard dietary recommendation ("healthy meals" condition)
Masking
Participant
Masking Description
Participants are only aware of the study condition in which they are allocated.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Home meals" condition
Arm Type
Experimental
Arm Description
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.
Arm Title
"Healthy meals" condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home meals
Intervention Description
Adult participants with overweight or obesity are asked to consume "home meals" during 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Healthy meals
Intervention Description
Adult participants with overweight or obesity are asked to consume "healthy meals" during 12 weeks.
Primary Outcome Measure Information:
Title
Change in weight and body fat
Description
Amount of weight/fat gained or lost during the intervention
Time Frame
Every four weeks during 12 weeks
Secondary Outcome Measure Information:
Title
Change in frequency of consumption of energy-dense foods or of exercise
Description
Change in number of times a week in which participants consumed energy dense foods or exercised relative to their baseline levels
Time Frame
Every four weeks during 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI of 25 kg/m2 or above
Exclusion Criteria:
Presence of chronic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Laguna Camacho, PhD
Organizational Affiliation
Universidad Autónoma del Estado de Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigación en Ciencias Médicas
City
Toluca
ZIP/Postal Code
50130
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Materials and dataset is available in the OSF platform
IPD Sharing Time Frame
22 August 2019
IPD Sharing URL
https://osf.io/uk95w/
Learn more about this trial
Effect of Consuming "Home Meals" on Body Weight
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