Childhood Obesity
Conditions
Keywords
Nutritional intervention, Childhood obesity, Physical activity, Feeding practices
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: 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.
Interventions
BEHAVIORALEating 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.
Sponsors
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
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 59 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | 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). |
| Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment | 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. |
| Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group | 3 months | We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity. |
Countries
Mexico
Participant flow
Recruitment details
Study staff screened 3095 children from March, 2012 to October, 2012 in Mexican Institute of Social Security (IMSS) clinics (Intervention (Ix) n=2111; Usual Care (UC) n=984). Staff approached parents and caregivers in the waiting rooms of clinics, weighed and measured children and parents completed a baseline questionnaire to determine eligibility.
Pre-assignment details
Of the 3095 (Ix n=2111; UC n=984) children initially screened, 1406 (Ix n=984; UC n=422) were eligible to participate and 306 (Ix n=168; UC n=138) agreed to participate. Of these 306, 189 (Ix n=93; UC n=96 control) participated in both the 3 and 6 month follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Eating and Physical Activity Counseling 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. | 168 |
| 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. | 138 |
| Total | 306 |
Baseline characteristics
| Characteristic | Usual Care | Eating and Physical Activity Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 138 Participants | 168 Participants | 306 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.42 years STANDARD_DEVIATION 0.82 | 3.34 years STANDARD_DEVIATION 0.84 | 3.38 years STANDARD_DEVIATION 0.83 |
| Region of Enrollment Mexico | 138 participants | 168 participants | 306 participants |
| Sex: Female, Male Female | 64 Participants | 81 Participants | 145 Participants |
| Sex: Female, Male Male | 74 Participants | 87 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 168 | 0 / 138 |
| serious Total, serious adverse events | 0 / 168 | 0 / 138 |
Outcome results
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).
Time frame: 0, 3 months
Population: Intent-to-treat analyses with multiple imputation to account for missing data. Were included in the analysis of children between 0 and 3 BMI z score, age between 24 and 59 months and parents signed letter of consent to participate in the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eating and Physical Activity Counseling | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Vegetables | -0.8 servings/week | Standard Error 0.2 |
| Eating and Physical Activity Counseling | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Fruit | 0.1 servings/week | Standard Error 0.2 |
| Eating and Physical Activity Counseling | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Water | -0.6 servings/week | Standard Error 0.2 |
| Eating and Physical Activity Counseling | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Sweet snacks | -9.7 servings/week | Standard Error 0.2 |
| Eating and Physical Activity Counseling | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Fast food | -0.4 servings/week | Standard Error 0 |
| Eating and Physical Activity Counseling | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Savory snacks | -0.7 servings/week | Standard Error 0 |
| Eating and Physical Activity Counseling | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Sugar-sweetened beverages | -6.0 servings/week | Standard Error 0.2 |
| Eating and Physical Activity Counseling | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Added sugar in beverages | -4.0 servings/week | Standard Error 0.2 |
| Usual Care | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Added sugar in beverages | -1.7 servings/week | Standard Error 0.2 |
| Usual Care | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Vegetables | -5.5 servings/week | Standard Error 0.2 |
| Usual Care | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Fast food | -0.2 servings/week | Standard Error 0 |
| Usual Care | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Fruit | -1.9 servings/week | Standard Error 0.4 |
| Usual Care | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Sugar-sweetened beverages | -3.2 servings/week | Standard Error 0.2 |
| Usual Care | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Water | -3.5 servings/week | Standard Error 0.2 |
| Usual Care | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Savory snacks | -0.5 servings/week | Standard Error 0 |
| Usual Care | Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment | Sweet snacks | -6.4 servings/week | Standard Error 0.3 |
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [1.8, 10.8]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-13.6, 10.3]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-5.4, 6.5]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-8.9, 1.1]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-0.5, 1.1]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-0.5, 0]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-4.9, 3.4]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-8.4, 4.1]Regression, Linear
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.
Time frame: 0, 3 months
Population: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 and to 6 months between the intervention and usual care groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eating and Physical Activity Counseling | Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment | Physical activiy | 2.9 hours/week | Standard Deviation 0.2 |
| Eating and Physical Activity Counseling | Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment | Sleep time | -0.3 hours/week | Standard Deviation 0 |
| Eating and Physical Activity Counseling | Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment | Screen time | -2.76 hours/week | Standard Deviation 0.1 |
| Usual Care | Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment | Screen time | -1.97 hours/week | Standard Deviation 0.1 |
| Usual Care | Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment | Physical activiy | 9.5 hours/week | Standard Deviation 0.4 |
| Usual Care | Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment | Sleep time | -0.1 hours/week | Standard Deviation 0 |
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI) are reported.p-value: <0.0595% CI: [-29.1, 5.5]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-0.2, 0.5]Regression, Linear
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-4.4, 1.1]Regression, Linear
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.
Time frame: 0, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eating and Physical Activity Counseling | Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment | -0.26 z score | Standard Error 0.01 |
| Usual Care | Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment | -0.44 z score | Standard Error 0.01 |
Comparison: In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.p-value: <0.0595% CI: [-0.04, 0.35]Regression, Linear
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eating and Physical Activity Counseling | Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group | 99 participants |
| Usual Care | Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group | 99 participants |