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Completed

NCT Number: NCT01539070

Intervention for the Prevention of Obesity in Preschool

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.

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Key information

Conditions

Childhood Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

24 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mexico City, 06720, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eating and physical activity counseling

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.

Other names: Nutritional intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Fogarty International Center of the National Institute of Health
  • Harvard Pilgrim Health Care
  • Hospital Infantil de Mexico Federico Gomez
  • Instituto Nacional de Salud Publica, Mexico
  • Inter-American Development Bank
  • University of Guelph

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2012
Registry last updated
Apr 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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