Intervention for the Prevention of Obesity in Preschool

Childhood Obesity Clinical Trial

Official title:

Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539070
• Other study ID #: 2009-785-120
• Secondary ID: HIM/2010/0251R03
• Status: Completed
• Phase: N/A
• First received: February 14, 2012
• Last updated: March 19, 2014
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Mexico	Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.	Mexico	Distrito Federal

Sponsors (7)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Harvard Pilgrim Health Care, Hospital Infantil de Mexico Federico Gomez, Instituto Nacional de Salud Publica, Mexico, Inter-American Development Bank, John E. Fogarty International Center (FIC), University of Guelph

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment	We asked parents about the average number of servings in the week or month the child consumed each food. We constructed grouped diet variables corresponding to food categories : sweet snacks (sugar-sweetened dairy, sugary cereal, cookies, sweet bread, cake, packaged pastries ], caramel pops, candies and chocolates); fast food (hamburgers, pizza, hot dogs, quesadillas, fried tacos, French fries); savory snacks (packaged snack foods, corn or potato chips); fruit (orange, mango, papaya, watermelon, grapes, apple, banana); vegetables (chard, broccoli, jitomate [tomato], nopales [cactus], chayote [squash], spinach, lettuce, zucchini, carrot); sugar-sweetened beverages (soda, flavored milk, homemade [agua fresca] and packaged fruit drinks); and added sugar in beverages (teaspoons sugar or sweet flavoring added to milk, coffee, tea, or fruit juice).	0, 3 months	No
Primary	Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment	Staff assisted parents in reporting the average time the participating child spent in pre-specified active and sedentary activities during the week and on weekends. For each of the pre-specified activities parents reported time spent in open-ended response format. From these responses we derived total hours/week of physical activity composed of active play (e.g. running, jumping, walking, playing ball, playing in the park, biking, swimming, dancing), as well as total hours/week of screen time, composed of television, DVD/video, and video and computer games.	0, 3 months	No
Primary	Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment	In order to calculate children's BMI and age and sex specific BMI z-scores at baseline and 3 month follow-up, study staff assessed child's height in meters and weight in kilograms. BMI was calculated as weight in kilograms divided by the square of height in meters.	0, 3 month	No
Secondary	Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group	We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.	3 months	No