Clinical trial NCT01539070: Intervention for the Prevention of Obesity in Preschool
Official title: Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Nutritional intervention
Childhood obesity
Physical activity
Feeding practices
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Infantil de Mexico Federico Gomez
name: Harvard Pilgrim Health Care
name: Fogarty International Center of the National Institute of Health
name: Inter-American Development Bank
name: Instituto Nacional de Salud Publica, Mexico
name: University of Guelph
First posted: 2012-02-27
Enrollment: 306
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment
timeFrame: 0, 3 months
measure: Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment
timeFrame: 0, 3 months
measure: Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment
timeFrame: 0, 3 month
Secondary outcomes:
measure: Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group
timeFrame: 3 months
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.
state: Distrito Federal
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Gloria Martínez Andrade, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Inter-American Development Bank
name: Ricardo Pérez Cuevas, Doctor
role: STUDY_DIRECTOR
affiliation: Harvard Pilgrim Health Care
name: Elsie Taveras, Doctor
role: STUDY_DIRECTOR
affiliation: Harvard Pilgrim Health Care
name: Matt Gillman, Doctor
role: STUDY_CHAIR
References:
citation: Martinez-Andrade GO, Cespedes EM, Rifas-Shiman SL, Romero-Quechol G, Gonzalez-Unzaga MA, Benitez-Trejo MA, Flores-Huerta S, Horan C, Haines J, Taveras EM, Perez-Cuevas R, Gillman MW. Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City. BMC Pediatr. 2014 Mar 20;14:77. doi: 10.1186/1471-2431-14-77.