TOPS: Toddler Overweight Prevention Study Among Low-Income Families

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT02615158
• Collaborator: Johns Hopkins University (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 277
• Locations: 2
• Arms: 3
• Duration (Months): 97
• Patients Per Site: 138.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in physical activity than toddlers with parents in a placebo (safety) intervention.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity; Depression	Behavioral: Maternal Physical Activity and Nutrition; Behavioral: Parenting; Behavioral: Child Safety	N/A

Detailed Description

Background:

Overweight is a serious public health problem which can begin in early childhood. Factors which contribute to overweight include: overfeeding, excessive intakes of fat and sugar; frequent sedentary activities (i.e. television watching).

Overweight, defined as a BMI > 95th percentile, in early childhood has reached epidemic proportions with 14% of 2-5 year olds overweight and 26.2% "at risk of overweight," defined as a BMI > 85th percentile (Ogden et al., 2006).

Dietary and physical activity patterns established early in life track over time, making the first few years of life an ideal time to help families establish healthy eating and physical activity behaviors and avoid overweight. This project works to identify techniques that could prevent overweight.

Purpose of Study:

The investigators are collaborating with the Anne Arundel County, MD Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and the University of Maryland's Pediatric Ambulatory Center to implement strategies that will prevent overweight among toddlers. The project focuses on the dietary, physical activity, and growth patterns of WIC toddlers. The investigators are conducting a 3-cell randomized trial consisting of: 1) a maternal intervention focusing on healthy diet and physical activity patterns for mothers; 2) a toddler parenting intervention focusing on parenting, limit setting, and development strategies; and 3) an intervention on child safety. The interventions are implemented over 3 months, with 8 sessions.

The investigators hypothesize that altering maternal behavior will have a positive impact on the growth and development of the toddler by preventing behaviors that lead to overweight among children. The parenting intervention will improve parenting skills by offering information on proper approaches to feeding, discipline and educational play. The investigators will compare the growth patterns of toddlers whose mothers were randomized to the maternal and parenting interventions with those in the safety intervention. This study design allows us to examine the mechanisms linking the interventions to improvements in diet, physical activity, and growth.

In addition, the investigators will conduct the safety promotion intervention for the attention control group, considering the high risk of unintentional injuries among the toddlers from low-income families. The investigators also hypothesize that the safety promotion intervention will reduce the safety problems of the toddlers' homes. The underlying mechanisms will be examined, if there is a significant intervention effect.

Study Design

• Study Type: Interventional
• Actual Enrollment: 277 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maternal Physical Activity and Nutrition A maternal intervention focusing on healthy diet and physical activity patterns for mothers.	Behavioral: Maternal Physical Activity and Nutrition; At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.
Experimental: Parenting A toddler parenting intervention focusing on parenting, limit setting, and development strategies.	Behavioral: Parenting; Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.
Experimental: Child Safety Attention control group. The parents received intervention to promote safety among toddlers.	Behavioral: Child Safety; The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.

Outcome Measures

Primary Outcome Measures

1. Change of Body Mass Index (BMI) Z-score for Toddlers [Baseline to 12-month Follow-up]

   Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.

2. Change in Body Mass Index (BMI) Score Among Mothers [Baseline to 12 month Follow-up]

   Change body mass index (BMI, kg/m^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.

Secondary Outcome Measures

1. Change of Diet Quality for Toddlers [Baseline to 12-month Follow-up]

   Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality.

2. Change of Diet Quality for Mothers [Baseline to 12-month Follow-up]

   Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal

3. Change of Child Physical Activity [Baseline to 12-month Follow-up]

   Physical activity is measured by wearing an accelerometer for 7 days. Using standards for toddlers, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.

4. Change of Maternal Physical Activity [Baseline-12 month follow up]

   Physical activity is measured by wearing an accelerometer for 7 days. Using standards for adults, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.

5. Feeding Style [Baseline to 12 month Follow-up]

   The Emotional Availability Scales (EAS) include 4 maternal scales (sensitivity, structuring, non-intrusiveness, and non-hostile) and 2 child scales (responsiveness and involvement), each rated on 7-point Likert scales, with high scores optimal. The maternal and child sub-scale scores were averaged for a total mealtime interaction score. The total score ranges from 1-7. Coders were trained until they demonstrated inter-rater reliability >0.80 based on intraclass correlation coefficients with 10 observations from the scale creator and 10 observations with the faculty coordinator. Inter-rater reliability was reviewed through weekly reliability checks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• At least 18 yrs old

• Has child between 12-32 months

• Child able to walk

• Birth weight of child at least 5lbs. 8oz.

Exclusion Criteria:

• Mom cannot be pregnant

• No known congenital problems or disabilities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland, School of Medicine	Baltimore	Maryland	United States	21201
2	University of Maryland	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore
• Johns Hopkins University
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Maureen M Black, PhD, University of Maryland, College Park

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study Website

Publications

• Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55.

• Responsible Party: Maureen Black, Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT02615158
• Other Study ID Numbers: H-27980; R01HD056099; R03HD077156
• First Posted: Nov 26, 2015
• Last Update Posted: May 12, 2020
• Last Verified: May 1, 2020

• Keywords provided by Maureen Black, Professor, University of Maryland, Baltimore: Feeding practices; Diet; Physical activity; Prevention
• Additional relevant MeSH terms: Overweight

Study Results

Participant Flow

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Period Title: Overall Study
STARTED	94	92	91
COMPLETED	73	76	75
NOT COMPLETED	21	16	16

Baseline Characteristics

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety	Total
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.	Total of all reporting groups
Overall Participants	94	92	91	277
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.17 (5.9)	27.53 (6.5)	28.16 (5.99)	27.28 (6.17)
Sex: Female, Male (Count of Participants)
Female	94 100%	92 100%	91 100%	277 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 2.1%	0 0%	3 3.3%	5 1.8%
Not Hispanic or Latino	92 97.9%	92 100%	88 96.7%	272 98.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	64 68.1%	67 72.8%	62 68.1%	193 69.7%
White	21 22.3%	19 20.7%	22 24.2%	62 22.4%
More than one race	7 7.4%	6 6.5%	5 5.5%	18 6.5%
Unknown or Not Reported	2 2.1%	0 0%	2 2.2%	4 1.4%
Region of Enrollment (participants) [Number]
United States	94 100%	92 100%	91 100%	277 100%
Maternal age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.17 (5.9)	27.53 (6.5)	28.16 (5.99)	27.28 (6.17)
Household Poverty Ratio (Count of Participants)
Count of Participants [Participants]	68 72.3%	59 64.1%	58 63.7%	185 66.8%
Maternal Education (Count of Participants)
Count of Participants [Participants]	74 78.7%	75 81.5%	75 82.4%	224 80.9%
Maternal Marital Status (Count of Participants)
Count of Participants [Participants]	24 25.5%	25 27.2%	29 31.9%	78 28.2%
Location (Urban/Semi-Urban) (Count of Participants)
Count of Participants [Participants]	56 59.6%	58 63%	53 58.2%	167 60.3%
Maternal BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.98 (9.48)	31.90 (9.78)	31.51 (9.24)	31.80 (9.47)
Maternal dietary intake (kcal/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kcal/day]	2281 (745)	2214 (1053)	2033 (738)	2177 (859)
Maternal physical activity (Minutes Mod/Vig Activity/Day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Minutes Mod/Vig Activity/Day]	23.22 (18.07)	26.14 (20.36)	27.52 (17.82)	25.54 (18.76)
Toddler age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	19.98 (5.55)	20.22 (5.56)	20.14 (5.46)	20.11 (5.50)
Toddler sex (Count of Participants)
Females	48 51.1%	37 40.2%	45 49.5%	130 46.9%
Males	46 48.9%	55 59.8%	46 50.5%	147 53.1%
Toddler race/ethnicity (Count of Participants)
Non-Hispanic African American	64 68.1%	67 72.8%	62 68.1%	193 69.7%
Non-Hispanic White	21 22.3%	19 20.7%	22 24.2%	62 22.4%
Hispanic	2 2.1%	0 0%	3 3.3%	5 1.8%
Mixed	7 7.4%	6 6.5%	4 4.4%	17 6.1%
Toddler Body Mass Index (BMI) Z-score (Body mass index z-scores) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Body mass index z-scores]	0.49 (1.10)	0.51 (1.16)	0.63 (1.14)	0.54 (1.13)
Toddler dietary intake (Total energy kcal/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Total energy kcal/day]	1282 (476)	1297 (463)	1262 (419)	1281 (453)
Toddler physical activity (Minutes Mod/Vig physical activity/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Minutes Mod/Vig physical activity/day]	45.45 (38.53)	52.99 (35.87)	64.62 (45.16)	54.08 (40.43)

Outcome Measures

1. Primary Outcome

Title	Change of Body Mass Index (BMI) Z-score for Toddlers
Description	Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.
Time Frame	Baseline to 12-month Follow-up

Outcome Measure Data

Analysis Population Description

Toddlers in low-income families, defined as WIC-eligible (income < 185% of poverty index). WIC=Special Supplementary Program for Women, Infants, and Children.

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Measure Participants	94	92	91
Toddlers BMI z-score at baseline	0.49 (0.12)	0.50 (0.12)	0.62 (0.12)
Toddler BMI z-score12-month follow-up	0.52 (0.12)	0.61 (0.12)	0.57 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maternal Lifestyle (Physical Activity and Nutrition), Child Safety
	Comments	H0: There are no differences between the maternal lifestyle and child safety groups in the change in BMI z-score over time. Mixed models included the interaction between time and intervention, accounting for clustering of the repeated measures within each individual.
	Type of Statistical Test	Equivalence
	Comments	If the 95% confidence interval of the difference in the change over time does not include 0, it means that there is a significant difference in the change over time between the two groups.
Statistical Test of Hypothesis	p-Value	0.555
	Comments	The alpha for statistical significance is set at 0.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -0.17 to 0.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments	This is to compare change in maternal lifestyle group to child safety group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Responsive Parenting, Child Safety
	Comments
	Type of Statistical Test	Equivalence
	Comments	95% CI
Statistical Test of Hypothesis	p-Value	0.200
	Comments	Two-side test
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 95%; -0.08 to 0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments	This is to compare the Responsive Parenting to the safety intervention group.

2. Primary Outcome

Title	Change in Body Mass Index (BMI) Score Among Mothers
Description	Change body mass index (BMI, kg/m^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.
Time Frame	Baseline to 12 month Follow-up

Outcome Measure Data

Analysis Population Description

Mothers of toddlers participating in study, low-income, defined as WIC-eligible.

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Measure Participants	94	92	91
Maternal BMI at baseline	31.98 (0.98)	31.90 (0.99)	31.51 (0.99)
Maternal BMI at 12-month follow-up	32.22 (0.99)	32.21 (0.99)	31.85 (1.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maternal Lifestyle (Physical Activity and Nutrition), Child Safety
	Comments	H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.
	Type of Statistical Test	Equivalence
	Comments	95% confidence interval (CI) was estimated. If the 95% CI does not include 0, it means there is significant difference in the change over time between the two groups.
Statistical Test of Hypothesis	p-Value	0.739
	Comments	The alpha for statistical significance is set at 0.05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.74 to 0.52
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments	This is to compare maternal lifestyle to child safety group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Responsive Parenting, Child Safety
	Comments	H0: There are no differences in the change over time between responsive parenting and child safety groups.
	Type of Statistical Test	Equivalence
	Comments	The 95% CI was estimated. If it does not include 0, it means that there is a statistically significant difference in the change over time between the two groups.
Statistical Test of Hypothesis	p-Value	0.904
	Comments	The alpha for statistical significance was set at 0.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95%; -0.66 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments	This is to compare the responsive parenting group to the child safety group.

3. Secondary Outcome

Title	Change of Diet Quality for Toddlers
Description	Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality.
Time Frame	Baseline to 12-month Follow-up

Outcome Measure Data

Analysis Population Description

Change in HEI 2015 score for toddlers from baseline to 12 months

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Measure Participants	94	92	91
Toddler HEI total at baseline	52.44 (1.18)	54.58 (1.20)	55.1 (1.19)
Toddler HEI total at 12-month follow-up	52.84 (1.38)	52.49 (1.36)	52.19 (1.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maternal Lifestyle (Physical Activity and Nutrition), Child Safety
	Comments	H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.
	Type of Statistical Test	Equivalence
	Comments	The 95% confidence interval (CI) for the difference in the change over time was estimated. If it does not include 0, it indicates significant difference in the change over time.
Statistical Test of Hypothesis	p-Value	0.168
	Comments	Alpha is set at 0.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	3.31
	Confidence Interval	(2-Sided) 95%; -1.4 to 8.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.40
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Responsive Parenting, Child Safety
	Comments	H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time
	Type of Statistical Test	Equivalence
	Comments	95% CI was estimated. If it does not include 0, it indicates that there is a significant difference in the change between the two groups.
Statistical Test of Hypothesis	p-Value	0.733
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; -3.88 to 5.52
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.39
	Estimation Comments	This is to compare the responsive feeding group to child safety group.

4. Secondary Outcome

Title	Change of Diet Quality for Mothers
Description	Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal
Time Frame	Baseline to 12-month Follow-up

Outcome Measure Data

Analysis Population Description

Mothers of toddlers

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Measure Participants	94	92	91
Baseline HEI 2015	46.88 (1.32)	48.71 (1.35)	48.52 (1.34)
12-month HEI 2015	48.39 (1.52)	46.90 (1.53)	46.74 (1.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maternal Lifestyle (Physical Activity and Nutrition), Child Safety
	Comments	Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.
	Type of Statistical Test	Equivalence
	Comments	The 95% CI was estimated. If it does not include 0, it indicates that there is significant difference in the change over time between the two groups.
Statistical Test of Hypothesis	p-Value	0.186
	Comments	Alpha is set at 0.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	3.30
	Confidence Interval	(2-Sided) 95%; -1.6 to 8.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.49
	Estimation Comments	This is to compare the maternal lifestyle group to the child safety group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Responsive Parenting, Child Safety
	Comments	H0 is there is no difference in the change of maternal HEI score over time between the two groups.
	Type of Statistical Test	Equivalence
	Comments	95% CI for the difference in change over time was estimated. If it does not include 0, it indicates that there is significant difference between the two groups.
Statistical Test of Hypothesis	p-Value	0.990
	Comments	Alpha is set to 0.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -4.97 to 4.91
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.51
	Estimation Comments	This is to compare the responsive parenting group to child safety group.

5. Secondary Outcome

Title	Change of Child Physical Activity
Description	Physical activity is measured by wearing an accelerometer for 7 days. Using standards for toddlers, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.
Time Frame	Baseline to 12-month Follow-up

Outcome Measure Data

Analysis Population Description

Toddlers who participated in the trial, from low-income families, defined as WIC-eligible

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Measure Participants	94	92	91
Toddler MVPA at baseline	44.56 (4.92)	52.39 (4.98)	64.18 (5.11)
Toddler MVPA at 12-month follow	73.10 (7.37)	71.05 (7.13)	69.05 (7.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maternal Lifestyle (Physical Activity and Nutrition), Child Safety
	Comments	Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.
	Type of Statistical Test	Equivalence
	Comments	A 95% CI was estimated. If it does not include 0, it indicates significant difference in change over time between the two groups.
Statistical Test of Hypothesis	p-Value	0.034
	Comments	Alpha is set at 0.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	23.67
	Confidence Interval	(2-Sided) 95%; 1.88 to 45.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 11.03
	Estimation Comments	This is for maternal lifestyle group compared to safety control group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Responsive Parenting, Child Safety
	Comments
	Type of Statistical Test	Equivalence
	Comments	H0 is that there is no difference between the change of MVPA over time between the two groups.
Statistical Test of Hypothesis	p-Value	0.216
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	13.52
	Confidence Interval	(2-Sided) 95%; -7.98 to 35.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 10.89
	Estimation Comments	This is to compare the responsive parenting group to child safety group.

6. Secondary Outcome

Title	Change of Maternal Physical Activity
Description	Physical activity is measured by wearing an accelerometer for 7 days. Using standards for adults, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.
Time Frame	Baseline-12 month follow up

Outcome Measure Data

Analysis Population Description

Change in the number of steps per day from baseline to 12-month follow-up in MVPA

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Measure Participants	94	92	91
Maternal MVPA at baseline	23.10 (2.06)	26.11 (2.17)	27.76 (2.17)
Maternal MVPA at 12-month follow	27.41 (3.07)	20.42 (3.21)	21.09 (3.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maternal Lifestyle (Physical Activity and Nutrition), Child Safety
	Comments	H0 is that there is no difference in the change of maternal MVPA over time between the two groups.
	Type of Statistical Test	Equivalence
	Comments	The 95% CI for the difference in the change between the two groups was estimated. If it does not include 0, it indicates that there is a significant difference by group in the change.
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	10.97
	Confidence Interval	(2-Sided) 95%; 1.46 to 20.48
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.82
	Estimation Comments	This is to compare the maternal lifestyle group to the child safety group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Responsive Parenting, Child Safety
	Comments	H0 is that there is no significant difference in the change of maternal MVPA between the two groups.
	Type of Statistical Test	Equivalence
	Comments	The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.
Statistical Test of Hypothesis	p-Value	0.804
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; -8.76 to 10.72
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.94
	Estimation Comments	This is to compare responsive parenting group to child safety group.

7. Secondary Outcome

Title	Feeding Style
Description	The Emotional Availability Scales (EAS) include 4 maternal scales (sensitivity, structuring, non-intrusiveness, and non-hostile) and 2 child scales (responsiveness and involvement), each rated on 7-point Likert scales, with high scores optimal. The maternal and child sub-scale scores were averaged for a total mealtime interaction score. The total score ranges from 1-7. Coders were trained until they demonstrated inter-rater reliability >0.80 based on intraclass correlation coefficients with 10 observations from the scale creator and 10 observations with the faculty coordinator. Inter-rater reliability was reviewed through weekly reliability checks.
Time Frame	Baseline to 12 month Follow-up

Outcome Measure Data

Analysis Population Description

Change in Emotional Availability Scale scores from baseline to 12-month follow-up

Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)	Responsive Parenting	Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.	A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.	Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Measure Participants	94	92	91
Maternal feeding style at baseline	4.69 (0.11)	4.42 (0.11)	4.71 (0.12)
Maternal feeding style at 12-month	5.07 (0.14)	5.19 (0.14)	5.46 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maternal Lifestyle (Physical Activity and Nutrition), Child Safety
	Comments	The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.
	Type of Statistical Test	Equivalence
	Comments	The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.
Statistical Test of Hypothesis	p-Value	0.056
	Comments	Alpha is set at 0.05 for statistical significance.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -0.78 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.21
	Estimation Comments	This is to compare maternal lifestyle group to the child safety group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Responsive Parenting, Child Safety
	Comments	The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.
	Type of Statistical Test	Equivalence
	Comments	Alpha is set at 0.05 to indicate statistical significance.
Statistical Test of Hypothesis	p-Value	0.896
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; -0.39 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.21
	Estimation Comments	This is to compare responsive parenting group to child safety group.

Adverse Events

Time Frame	Adverse events were monitored over the time period that participants were actively participating in the study and assessments (e.g., 12 months for each participant or until the final assessment was completed).
Adverse Event Reporting Description	Data Safety Monitoring Committee reviewed records and interviewed project coordinator.
Arm/Group Title	Maternal Lifestyle (Physical Activity and Nutrition)		Responsive Parenting		Child Safety
Arm/Group Description	A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers. Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.		A responsive parenting intervention focusing on parenting, limit setting, and development strategies. Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.		Attention control group. The parents received intervention to promote safety among toddlers. Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
All Cause Mortality
	Maternal Lifestyle (Physical Activity and Nutrition)		Responsive Parenting		Child Safety
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		0/92 (0%)		0/91 (0%)
Serious Adverse Events
	Maternal Lifestyle (Physical Activity and Nutrition)		Responsive Parenting		Child Safety
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		0/92 (0%)		0/91 (0%)
Other (Not Including Serious) Adverse Events
	Maternal Lifestyle (Physical Activity and Nutrition)		Responsive Parenting		Child Safety
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		0/92 (0%)		0/91 (0%)

Limitations/Caveats

Data analysis was delayed due to extended period of time for coding the mother-toddler interaction data, related to personnel and funding.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.