Intervention for the Prevention of Obesity in Preschool

NCT ID: NCT01539070

Last Updated: 2014-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-06-30

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.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Eating and physical activity counseling

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.

Group Type: EXPERIMENTAL

Eating and physical activity counseling

Intervention Type: BEHAVIORAL

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.

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Nutritional intervention

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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil de Mexico Federico Gomez

OTHER

Sponsor Role: collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Inter-American Development Bank

OTHER

Sponsor Role: collaborator

Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role: collaborator

University of Guelph

OTHER

Sponsor Role: collaborator

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gloria Oliva Martinez Andrade

Investigador Asociado A

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gloria Martínez Andrade, Master

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Ricardo Pérez Cuevas, Doctor

Role: STUDY_DIRECTOR

Inter-American Development Bank

Elsie Taveras, Doctor

Role: STUDY_DIRECTOR

Harvard Pilgrim Health Care

Matt Gillman, Doctor

Role: STUDY_CHAIR

Harvard Pilgrim Health Care

Locations

Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.

Mexico City, Mexico City, Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 24649831 (View on PubMed)

Other Identifiers

HIM/2010/025

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R03TW008708

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009-785-120

Identifier Type: -

Identifier Source: org_study_id