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Intervention for the Prevention of Obesity in Preschool

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ClinicalTrials.gov Identifier: NCT01539070
Recruitment Status : Completed
First Posted : February 27, 2012
Results First Posted : April 22, 2014
Last Update Posted : April 22, 2014
Hospital Infantil de Mexico Federico Gomez
Harvard Pilgrim Health Care
John E. Fogarty International Center (FIC)
Inter-American Development Bank
Instituto Nacional de Salud Publica, Mexico
University of Guelph
Information provided by (Responsible Party):
Gloria Oliva Martinez Andrade, Coordinación de Investigación en Salud, Mexico

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.

Condition or disease Intervention/treatment
Childhood Obesity Behavioral: Eating and physical activity counseling

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children
Study Start Date : March 2012
Primary Completion Date : April 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
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
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.

Primary Outcome Measures :
  1. Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment [ Time Frame: 0, 3 months ]
    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).

  2. Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment [ Time Frame: 0, 3 months ]
    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.

  3. Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment [ Time Frame: 0, 3 month ]
    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.

Secondary Outcome Measures :
  1. Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group [ Time Frame: 3 months ]
    We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539070

Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.
Mexico, Distrito Federal, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Hospital Infantil de Mexico Federico Gomez
Harvard Pilgrim Health Care
John E. Fogarty International Center (FIC)
Inter-American Development Bank
Instituto Nacional de Salud Publica, Mexico
University of Guelph
Principal Investigator: Gloria Martínez Andrade, Master Instituto Mexicano del Seguro Social
Study Director: Ricardo Pérez Cuevas, Doctor Inter-American Development Bank
Study Director: Elsie Taveras, Doctor Harvard Pilgrim Health Care
Study Chair: Matt Gillman, Doctor Harvard Pilgrim Health Care

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gloria Oliva Martinez Andrade, Investigador Asociado A, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01539070     History of Changes
Other Study ID Numbers: 2009-785-120
HIM/2010/025 ( Other Grant/Funding Number: Hospital Infantil de México )
1R03TW008708 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2012    Key Record Dates
Results First Posted: April 22, 2014
Last Update Posted: April 22, 2014
Last Verified: March 2014

Keywords provided by Gloria Oliva Martinez Andrade, Coordinación de Investigación en Salud, Mexico:
Nutritional intervention
Childhood obesity
Physical activity
Feeding practices

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms