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Intervention for the Prevention of Obesity in Preschool

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Eating and physical activity counseling
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Nutritional intervention, Childhood obesity, Physical activity, Feeding practices

Eligibility Criteria

24 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Eating and physical activity counseling

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 14, 2012
Last Updated
March 19, 2014
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Hospital Infantil de Mexico Federico Gomez, Harvard Pilgrim Health Care, Fogarty International Center of the National Institute of Health, Inter-American Development Bank, Instituto Nacional de Salud Publica, Mexico, University of Guelph
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1. Study Identification

Unique Protocol Identification Number
NCT01539070
Brief Title
Intervention for the Prevention of Obesity in Preschool
Official Title
Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Hospital Infantil de Mexico Federico Gomez, Harvard Pilgrim Health Care, Fogarty International Center of the National Institute of Health, Inter-American Development Bank, Instituto Nacional de Salud Publica, Mexico, University of Guelph

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Nutritional intervention, Childhood obesity, Physical activity, Feeding practices

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eating and physical activity counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eating and physical activity counseling
Other Intervention Name(s)
Nutritional intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment
Description
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).
Time Frame
0, 3 months
Title
Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment
Description
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.
Time Frame
0, 3 months
Title
Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment
Description
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.
Time Frame
0, 3 month
Secondary Outcome Measure Information:
Title
Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group
Description
We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Martínez Andrade, Master
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo Pérez Cuevas, Doctor
Organizational Affiliation
Inter-American Development Bank
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elsie Taveras, Doctor
Organizational Affiliation
Harvard Pilgrim Health Care
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Matt Gillman, Doctor
Organizational Affiliation
Harvard Pilgrim Health Care
Official's Role
Study Chair
Facility Information:
Facility Name
Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24649831
Citation
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.
Results Reference
derived

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Intervention for the Prevention of Obesity in Preschool

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