Effect of Consuming "Home Meals" on Body Weight

NCT ID: NCT03653559

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-06-30

Brief Summary

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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

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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

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial. The model tests a new dietary recommendation ("home meals" condition) against a standard dietary recommendation ("healthy meals" condition)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants are only aware of the study condition in which they are allocated.

Study Groups

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"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.

Group Type EXPERIMENTAL

Home meals

Intervention Type BEHAVIORAL

Adult participants with overweight or obesity are asked to consume "home meals" during 12 weeks.

"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.

Group Type ACTIVE_COMPARATOR

Healthy meals

Intervention Type BEHAVIORAL

Adult participants with overweight or obesity are asked to consume "healthy meals" during 12 weeks.

Interventions

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Home meals

Adult participants with overweight or obesity are asked to consume "home meals" during 12 weeks.

Intervention Type BEHAVIORAL

Healthy meals

Adult participants with overweight or obesity are asked to consume "healthy meals" during 12 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI of 25 kg/m2 or above

Exclusion Criteria

* Presence of chronic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

58 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma del Estado de Mexico

OTHER

Sponsor Role lead

Responsible Party

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Antonio Laguna Camacho

Full-time Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Laguna Camacho, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Autónoma del Estado de Mexico

Locations

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Centro de Investigación en Ciencias Médicas

Toluca, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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15CI1506014

Identifier Type: -

Identifier Source: org_study_id