Intervention for the Prevention of Obesity in Preschool

NCT01539070 | Completed Results

• 3 other identifiers: 2009-785-120HIM/2010/0251R03TW008708
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Nutritional intervention; Childhood obesity; Physical activity; Feeding practices

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (1)

• Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group

  3 months

Study Arms (2)

Eating and physical activity counseling

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

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.

Also known as: Nutritional intervention

Eating and physical activity counseling

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (1)

• 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.

  PMID: 24649831 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Interventions

Eating

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Limitations and Caveats

35% of families did not complete follow-up at 3 months, our primary endpoint. To address the resulting bias from missing data we performed multiple imputation of missing information on covariates and behavioral and BMI outcomes.

Results Point of Contact

• Title: MPH. Gloria Oliva Martínez Andrade
• Organization: Instituto Mexicano del Seguro Social

gloria_olivam@hotmail.com

5556059862

Study Officials

• Gloria Martínez Andrade, Master

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Ricardo Pérez Cuevas, Doctor

  Inter-American Development Bank

  STUDY DIRECTOR

• Elsie Taveras, Doctor

  Harvard Pilgrim Health Care

  STUDY DIRECTOR

• Matt Gillman, Doctor

  Harvard Pilgrim Health Care

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Asociado A

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 27, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 22, 2014
• Results First Posted: April 22, 2014

Record last verified: 2014-03

Locations

ME (1)