Childhood Obesity Prevention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hospital Infantil de Mexico Federico Gomez
Harvard Pilgrim Health Care
Interamerican Development Bank
Instituto Nacional de Salud Publica, Mexico
University of Guelph
Information provided by (Responsible Party):
Gloria Oliva Martinez Andrade, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01539070
First received: February 14, 2012
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to develop, implement and evaluate an intervention focused to change feeding practices and patterns of physical activity of preschool children through providing motivational counseling to the mother. The aim is to prevent obesity in children aged 2 to 4 years 11 months with risk of overweight or with overweight.


Condition Intervention
Childhood Obesity
Behavioral: Eating and physical activity counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Change in children´s consumption of food high in calories [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in children´s time of physical activity [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of the intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Feasibility will be evaluated through:

    1. level of mother's participation in the study,
    2. mother's attrition rate
    3. percentage of attendance to the sessions.


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eating and physical activity counseling Behavioral: Eating and physical activity counseling

The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.

There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity.

Other Name: Nutritional intervention
No Intervention: Usual care

Detailed Description:

Obesity has a multi-causal origin in which participate, in a similar way, the individual behavior and family and community contexts and the social environment.

Participation of primary care services is key to solve the problem. These services have the possibility to detect timely children with high body mass index, and to promote behavior to improve feeding practices and physical activity in both, the child and his family.

The study is divided in two stages:

  1. Design of the intervention. The researchers will use qualitative methods to evaluate feeding practices, physical activity and the environment in which such behaviors are generated. In a similar way the care provided by health professionals to overweight and obese children it will be evaluated; this includes the perception that health providers have about this problem. The information will allow identifying risk behavior and healthy behavior, facilitators and obstacles to receive care. The results will serve to define the contents of the intervention.
  2. Intervention: The study will take place in four family medicine clinics belonging to the Mexican Institute of Social Security. Two clinics will receive the intervention and two will serve as control. In each clinic, fifty children and their mothers will be recruited. At the intervention clinics, the group of mothers will participate in seven weekly sessions and in two individual sessions at 3 and 6 months after the group sessions finish. During the sessions, the researchers will motivate the mothers to change feeding practices and encourage physical exercise of the children and family, this will improve the chance for their children for healthy growing. The control group will receive the usual care that consists only in the recommendations that the family doctor provides.

The evaluation of the study comprise feasibility and acceptability of the intervention and its effect in the behavior of the mothers in terms of changing feeding practices and practicing physical exercise.

  Eligibility

Ages Eligible for Study:   24 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children between 2 and 4 years and 11 months of age at the beginning of the study.
  • Overweight children, defined as a BMI score of z > = 1.5 and < +3 based on the WHO standards.
  • The children's parents accept participation in the study.

Exclusion Criteria:

  • Families who plan on changing their address during the study.
  • Families whose doctor considers them to be inappropriate for participation in the intervention, as with emotional or mental alterations.
  • Children who require a special diet for medical reasons or children with limited motor functioning.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539070

Locations
Mexico
Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.
Mexico, Distrito Federal, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Hospital Infantil de Mexico Federico Gomez
Harvard Pilgrim Health Care
Interamerican Development Bank
Instituto Nacional de Salud Publica, Mexico
University of Guelph
Investigators
Principal Investigator: Gloria Martínez Andrade, Master Instituto Mexicano del Seguro Social
Study Director: Ricardo Pérez Cuevas, Doctor Interamerican Development Bank
Study Director: Elsie Taveras, Doctor Harvard Pilgrim Health Care
Study Chair: Matt Gillman, Doctor Harvard Pilgrim Health Care
  More Information

No publications provided

Responsible Party: Gloria Oliva Martinez Andrade, Investigador Asociado A, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01539070     History of Changes
Other Study ID Numbers: 2009-785-120, HIM/2010/025, 1R03TW008708
Study First Received: February 14, 2012
Last Updated: January 11, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Nutritional intervention
Childhood obesity
Physical activity
Feeding practices

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014