Trial Outcomes & Findings for Intervention for the Prevention of Obesity in Preschool (NCT NCT01539070)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

306 participants

Primary outcome timeframe

0, 3 months

Results posted on

2014-04-22

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	168	138
Overall Study COMPLETED	109	99
Overall Study NOT COMPLETED	59	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intervention for the Prevention of Obesity in Preschool

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eating and Physical Activity Counseling n=168 Participants 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.	Usual Care n=138 Participants 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.	Total n=306 Participants Total of all reporting groups
Age, Categorical <=18 years	168 Participants n=5 Participants	138 Participants n=7 Participants	306 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	3.34 years STANDARD_DEVIATION 0.84 • n=5 Participants	3.42 years STANDARD_DEVIATION 0.82 • n=7 Participants	3.38 years STANDARD_DEVIATION 0.83 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	64 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	74 Participants n=7 Participants	161 Participants n=5 Participants
Region of Enrollment Mexico	168 participants n=5 Participants	138 participants n=7 Participants	306 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Eating and Physical Activity Counseling n=168 Participants 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.	Usual Care n=138 Participants 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.
Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment Vegetables	-0.8 servings/week Standard Error 0.2	-5.5 servings/week Standard Error 0.2
Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment Fruit	0.1 servings/week Standard Error 0.2	-1.9 servings/week Standard Error 0.4
Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment Water	-0.6 servings/week Standard Error 0.2	-3.5 servings/week Standard Error 0.2
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	-6.4 servings/week Standard Error 0.3
Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment Fast food	-0.4 servings/week Standard Error 0.0	-0.2 servings/week Standard Error 0.0
Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment Savory snacks	-0.7 servings/week Standard Error 0	-0.5 servings/week Standard Error 0
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	-3.2 servings/week Standard Error 0.2
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	-1.7 servings/week Standard Error 0.2

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Eating and Physical Activity Counseling n=168 Participants 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.	Usual Care n=138 Participants 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.
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	9.5 hours/week Standard Deviation 0.4
Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment Sleep time	-0.3 hours/week Standard Deviation 0.0	-0.1 hours/week Standard Deviation 0.0
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	-1.97 hours/week Standard Deviation 0.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Eating and Physical Activity Counseling n=168 Participants 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.	Usual Care n=138 Participants 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.
Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment	-0.26 z score Standard Error 0.01	-0.44 z score Standard Error 0.01

SECONDARY outcome

Timeframe: 3 months

We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.

Outcome measures

Outcome measures
Measure	Eating and Physical Activity Counseling n=168 Participants 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.	Usual Care n=138 Participants 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.
Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group	99 participants	99 participants

Adverse Events

Eating and Physical Activity Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MPH. Gloria Oliva Martínez Andrade

Instituto Mexicano del Seguro Social

Phone: 5556059862

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place