Childhood Obesity Clinical Trial
Official title:
Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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 |
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 |
Mexico,
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 |
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