Intervention for the Prevention of Obesity in Preschool | NCT01539070

ID	Type	Description	Link
HIM/2010/025	Other Grant/Funding Number	Hospital Infantil de México
1R03TW008708	U.S. NIH Grant/Contract		View source

Intervention for the Prevention of Obesity in Preschool | NCT01539070 | Trialant

Sponsor/Collaborators Module

Name	Class
Hospital Infantil de Mexico Federico Gomez	OTHER
Harvard Pilgrim Health Care	OTHER
Fogarty International Center of the National Institute of Health	NIH

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.		Mexico City	Mexico City	06720	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24649831	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000168 subjects FG001138 subjects
COMPLETED		FG000109 subjects FG00199 subjects
NOT COMPLETED		FG00059 subjects FG00139 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
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).	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	Posted		Mean	Standard Error	servings/week		0, 3 months

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
MPH. Gloria Oliva Martínez Andrade	Instituto Mexicano del Seguro Social	5556059862	21075	gloria_olivam@hotmail.com

Condition Browse Module

ID	Term
D063766	Pediatric Obesity
D009043	Motor Activity

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Intervention Browse Module

ID	Term
D004435	Eating

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D004068	Digestive System Physiological Phenomena

ID	Title	Description
OG000	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.
OG001	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.

Title

Denominators

Categories

Vegetables

Title	Measurements
	OG000-0.8± 0.2 OG001-5.5± 0.2

Fruit

Title	Measurements
	OG0000.1± 0.2 OG001-1.9± 0.4

Water

Title	Measurements
	OG000-0.6± 0.2 OG001-3.5± 0.2

Sweet snacks

Title	Measurements
	OG000-9.7± 0.2 OG001-6.4± 0.3

Fast food

Title	Measurements
	OG000-0.4± 0.0 OG001-0.2± 0.0

Savory snacks

Title	Measurements
	OG000-0.7± 0 OG001-0.5± 0

Sugar-sweetened beverages

Title	Measurements
	OG000-6.0± 0.2 OG001-3.2± 0.2

Added sugar in beverages

Title	Measurements
	OG000-4.0± 0.2 OG001-1.7± 0.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	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.	Regression, Linear	All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season	<0.05	Mean Difference (Final Values)	6.3	2-Sided	95	1.8	10.8	The change in the average vegetable consumption from baseline to 3 months, the intervention group compared with the usual care group	No	Superiority or Other
OG000 OG001	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.	Regression, Linear		<0.05	Mean Difference (Final Values)	-1.6	2-Sided	95	-13.6	10.3	The change in the average fruit consumption from baseline to 3 months, the intervention group compared with the usual care group	No	Superiority or Other
OG000 OG001	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.	Regression, Linear		<0.05	Mean Difference (Final Values)	0.6	2-Sided	95	-5.4	6.5	The change in the average water consumption from baseline to 3 months, the intervention group compared with the usual care group	No	Superiority or Other
OG000 OG001	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.	Regression, Linear		<0.05	Mean Difference (Final Values)	-3.9	2-Sided	95	-8.9	1.1	The change in the average sweet snacks consumption from baseline to 3 months, the intervention group compared with the usual care group	No	Superiority or Other
OG000 OG001	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.	Regression, Linear		<0.05	Mean Difference (Final Values)	0.3	2-Sided	95	-0.5	1.1	The change in the average fast food consumption from baseline to 3 months, the intervention group compared with the usual care group	No	Superiority or Other
OG000 OG001	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.	Regression, Linear		<0.05	Mean Difference (Final Values)	-0.3	2-Sided	95	-0.5	0.0	The change in the average savory snacks consumption from baseline to 3 months, the intervention group compared with the usual care group	No	Superiority or Other
OG000 OG001	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.	Regression, Linear		<0.05	Mean Difference (Final Values)	-0.7	2-Sided	95	-4.9	3.4	The change in the average sugar-sweetened beverage consumption from baseline to 3 months, the intervention group compared with the usual care group	No	Superiority or Other
OG000 OG001	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.	Regression, Linear		<0.05	Mean Difference (Final Values)	-2.2	2-Sided	95	-8.4	4.1	The change in the average added sugar in beverage consumption from baseline to 3 months, the intervention group compared with the usual care group	No	Superiority or Other

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.

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.

Posted

Mean

Standard Deviation

hours/week

0, 3 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000168 OG001138

Title

Denominators

Categories

Physical activiy

Title	Measurements
	OG0002.9± 0.2 OG0019.5± 0.4

Sleep time

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Regression, Linear	All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season	<0.05		Mean Difference (Final Values)	-11.8			2-Sided	95	-29.1	5.5			The change in mean physical activity between the baseline measurement and 3 months, the intervention group compared with the control group

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.

Posted

Number

participants

3 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000168 OG001138

Title

Denominators

Categories

Title	Measurements
	OG00099 OG00199

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.

Posted

Mean

Standard Error

z score

0, 3 month

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000168 OG001138

Title

Denominators

Categories

Title	Measurements
	OG000-0.26± 0.01 OG001-0.44± 0.01

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Regression, Linear		<0.05		Mean Difference (Final Values)	0.15			2-Sided	95	-0.04	0.35				No	Superiority or Other