NCT02258802

Brief Summary

The purpose of this study is to develop, implement and evaluate a psychoeducational intervention focused to improve nutritional status, specifically micronutrients, of mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

September 30, 2014

Last Update Submit

May 11, 2016

Conditions

Keywords

psychoeducational interventionnutrition interventionmalnutritionmicronutrient deficiencynutrition transition

Outcome Measures

Primary Outcomes (1)

  • Change in food knowledge and behaviour

    questionnaire

    baseline, 6 months, 1 year

Secondary Outcomes (7)

  • Change in vegetable intake

    baseline, 1 year

  • Change in dietary practices

    baseline, 6 months, 1 year

  • Change in food waste

    baseline, 6 months, 1 year

  • Change in cognitive development in children

    baseline, 1 year

  • Change in anthropometry

    baseline, 6 months, 1 year

  • +2 more secondary outcomes

Study Arms (2)

Psychoeducational intervention

EXPERIMENTAL

Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.

Behavioral: Psychoeducational intervention

Usual food practices

NO INTERVENTION

These are participants from the communities where the intervention is active but are not attending the cooking lessons.

Interventions

A mobile kitchen visits the 5 selected communities every 2 weeks for a period of 1 year. A 30 minute cooking lesson is given by a trained instructor, the recipes have been designed to be quick and easy to make, use local and inexpensive ingredients, contain mostly vegetables and have a good taste. During the lesson, healthy habit and cooking tips are mentioned. A printed version of the recipe is given to every participant. Every lesson a different participant is encouraged to help prepare the recipe. At the end of the lesson all the participants get to taste the meal and express their opinion.

Also known as: Psychoeducational intervention in nutrition
Psychoeducational intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 60 years
  • Premenopausal
  • BMI \< 45 during enrollment
  • Apparently healthy
  • With a child in her care between the ages of 5 and 13 years

You may not qualify if:

  • Pregnant or breastfeeding
  • With a hysterectomy in the past 3 months
  • Alcohol consumption \> 14 drinks a week
  • Use of vitamin supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Child Nutrition DisordersMalnutrition

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Ana Carla Cepeda-Lopez, PhD

    Universidad de Monterrey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 7, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share