Effect of Consuming "Home Meals" on Body Weight

NCT03653559 | Completed

• 1 other identifier: 15CI1506014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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".

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Change in weight and body fat

  Amount of weight/fat gained or lost during the intervention

  Every four weeks during 12 weeks

Secondary Outcomes (1)

• Change in frequency of consumption of energy-dense foods or of exercise

  Every four weeks during 12 weeks

Study Arms (2)

"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.

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.

Behavioral: Healthy meals

Interventions

Home meals BEHAVIORAL

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

"Home meals" condition

Healthy meals BEHAVIORAL

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

"Healthy meals" condition

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI of 25 kg/m2 or above

You may not qualify if:

• Presence of chronic disease

Sponsors & Collaborators

• Universidad Autonoma del Estado de Mexico: lead

Study Sites (1)

Centro de Investigación en Ciencias Médicas

Toluca, 50130, Mexico

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Laguna Camacho, PhD

  Universidad Autónoma del Estado de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are only aware of the study condition in which they are allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-time Professor

Model Details: Randomised controlled trial. The model tests a new dietary recommendation ("home meals" condition) against a standard dietary recommendation ("healthy meals" condition)

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 31, 2018
• Study Start: January 15, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: 22 August 2019

Locations

ME (1)