Childhood Obesity Prevention
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.
|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|
- 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 ]
- Feasibility of the intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Feasibility will be evaluated through:
- level of mother's participation in the study,
- mother's attrition rate
- percentage of attendance to the sessions.
|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)|
|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|
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:
- 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.
- 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.
|Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.|
|Mexico, Distrito Federal, Mexico, 06720|
|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|