Intervention for the Prevention of Obesity in Preschool

Coordinación de Investigación en Salud, Mexico

Status: Completed

Conditions: Childhood Obesity

Treatments: Behavioral: Eating and physical activity counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01539070

1R03TW008708 (U.S. NIH Grant/Contract)

2009-785-120

HIM/2010/025 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: All

Ages: 24 to 59 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

Eating and physical activity counseling

Experimental group

Description:

Participants randomized to intervention received a 6 week curriculum focused on obesity awareness and prevention. A trained nutritionist led diet, healthy growth and physical activity workshops, while a health educator led workshops on instilling healthy habits and routines in childhood. The nurse provided child care and developed relevant games and activities for children while parents attended the workshops.

Treatment:

Behavioral: Eating and physical activity counseling

Usual care

No Intervention group

Description:

According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.