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Toddler Overweight Prevention Study Among Low-Income Families

Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02615158
Acronym
TOPS
Enrollment
277
Registered
2015-11-26
Start date
2006-04-30
Completion date
2014-05-31
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Obesity, Overweight

Keywords

Feeding practices, Diet, Physical activity, Prevention

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.

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.

Interventions

BEHAVIORALMaternal 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.

BEHAVIORALParenting

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.

BEHAVIORALChild 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change of Body Mass Index (BMI) Z-score for ToddlersBaseline to 12-month Follow-upMeasured 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.
Change in Body Mass Index (BMI) Score Among MothersBaseline to 12 month Follow-upChange 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

MeasureTime frameDescription
Change of Diet Quality for MothersBaseline to 12-month Follow-upHealthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal
Change of Child Physical ActivityBaseline to 12-month Follow-upPhysical 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.
Feeding StyleBaseline to 12 month Follow-upThe 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.
Change of Maternal Physical ActivityBaseline-12 month follow upPhysical 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.
Change of Diet Quality for ToddlersBaseline to 12-month Follow-upHealthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality.

Countries

United States

Participant flow

Participants by arm

ArmCount
Maternal Lifestyle (Physical Activity and Nutrition)
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.
94
Responsive Parenting
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.
92
Child Safety
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.
91
Total277

Baseline characteristics

CharacteristicMaternal Lifestyle (Physical Activity and Nutrition)Responsive ParentingChild SafetyTotal
Age, Continuous26.17 years
STANDARD_DEVIATION 5.9
27.53 years
STANDARD_DEVIATION 6.5
28.16 years
STANDARD_DEVIATION 5.99
27.28 years
STANDARD_DEVIATION 6.17
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants3 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
92 Participants92 Participants88 Participants272 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Household Poverty Ratio68 Participants59 Participants58 Participants185 Participants
Location (Urban/Semi-Urban)56 Participants58 Participants53 Participants167 Participants
Maternal age26.17 years
STANDARD_DEVIATION 5.9
27.53 years
STANDARD_DEVIATION 6.5
28.16 years
STANDARD_DEVIATION 5.99
27.28 years
STANDARD_DEVIATION 6.17
Maternal BMI31.98 kg/m^2
STANDARD_DEVIATION 9.48
31.90 kg/m^2
STANDARD_DEVIATION 9.78
31.51 kg/m^2
STANDARD_DEVIATION 9.24
31.80 kg/m^2
STANDARD_DEVIATION 9.47
Maternal dietary intake2281 kcal/day
STANDARD_DEVIATION 745
2214 kcal/day
STANDARD_DEVIATION 1053
2033 kcal/day
STANDARD_DEVIATION 738
2177 kcal/day
STANDARD_DEVIATION 859
Maternal Education74 Participants75 Participants75 Participants224 Participants
Maternal Marital Status24 Participants25 Participants29 Participants78 Participants
Maternal physical activity23.22 Minutes Mod/Vig Activity/Day
STANDARD_DEVIATION 18.07
26.14 Minutes Mod/Vig Activity/Day
STANDARD_DEVIATION 20.36
27.52 Minutes Mod/Vig Activity/Day
STANDARD_DEVIATION 17.82
25.54 Minutes Mod/Vig Activity/Day
STANDARD_DEVIATION 18.76
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
64 Participants67 Participants62 Participants193 Participants
Race (NIH/OMB)
More than one race
7 Participants6 Participants5 Participants18 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants2 Participants4 Participants
Race (NIH/OMB)
White
21 Participants19 Participants22 Participants62 Participants
Region of Enrollment
United States
94 participants92 participants91 participants277 participants
Sex: Female, Male
Female
94 Participants92 Participants91 Participants277 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants
Toddler age19.98 months
STANDARD_DEVIATION 5.55
20.22 months
STANDARD_DEVIATION 5.56
20.14 months
STANDARD_DEVIATION 5.46
20.11 months
STANDARD_DEVIATION 5.5
Toddler Body Mass Index (BMI) Z-score0.49 Body mass index z-scores
STANDARD_DEVIATION 1.1
0.51 Body mass index z-scores
STANDARD_DEVIATION 1.16
0.63 Body mass index z-scores
STANDARD_DEVIATION 1.14
0.54 Body mass index z-scores
STANDARD_DEVIATION 1.13
Toddler dietary intake1282 Total energy kcal/day
STANDARD_DEVIATION 476
1297 Total energy kcal/day
STANDARD_DEVIATION 463
1262 Total energy kcal/day
STANDARD_DEVIATION 419
1281 Total energy kcal/day
STANDARD_DEVIATION 453
Toddler physical activity45.45 Minutes Mod/Vig physical activity/day
STANDARD_DEVIATION 38.53
52.99 Minutes Mod/Vig physical activity/day
STANDARD_DEVIATION 35.87
64.62 Minutes Mod/Vig physical activity/day
STANDARD_DEVIATION 45.16
54.08 Minutes Mod/Vig physical activity/day
STANDARD_DEVIATION 40.43
Toddler race/ethnicity
Hispanic
2 Participants0 Participants3 Participants5 Participants
Toddler race/ethnicity
Mixed
7 Participants6 Participants4 Participants17 Participants
Toddler race/ethnicity
Non-Hispanic African American
64 Participants67 Participants62 Participants193 Participants
Toddler race/ethnicity
Non-Hispanic White
21 Participants19 Participants22 Participants62 Participants
Toddler sex
Females
48 Participants37 Participants45 Participants130 Participants
Toddler sex
Males
46 Participants55 Participants46 Participants147 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 940 / 920 / 91
other
Total, other adverse events
0 / 940 / 920 / 91
serious
Total, serious adverse events
0 / 940 / 920 / 91

Outcome results

Primary

Change in Body Mass Index (BMI) Score Among Mothers

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Maternal Lifestyle (Physical Activity and Nutrition)Change in Body Mass Index (BMI) Score Among MothersMaternal BMI at baseline31.98 kg/m^2Standard Deviation 0.98
Maternal Lifestyle (Physical Activity and Nutrition)Change in Body Mass Index (BMI) Score Among MothersMaternal BMI at 12-month follow-up32.22 kg/m^2Standard Deviation 0.99
Responsive ParentingChange in Body Mass Index (BMI) Score Among MothersMaternal BMI at baseline31.90 kg/m^2Standard Deviation 0.99
Responsive ParentingChange in Body Mass Index (BMI) Score Among MothersMaternal BMI at 12-month follow-up32.21 kg/m^2Standard Deviation 0.99
Child SafetyChange in Body Mass Index (BMI) Score Among MothersMaternal BMI at baseline31.51 kg/m^2Standard Deviation 0.99
Child SafetyChange in Body Mass Index (BMI) Score Among MothersMaternal BMI at 12-month follow-up31.85 kg/m^2Standard Deviation 1
Comparison: H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.p-value: 0.73995% CI: [-0.74, 0.52]Mixed Models Analysis
Comparison: H0: There are no differences in the change over time between responsive parenting and child safety groups.p-value: 0.90495% CI: [-0.66, 0.59]Mixed Models Analysis
Primary

Change of Body Mass Index (BMI) Z-score for Toddlers

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Maternal Lifestyle (Physical Activity and Nutrition)Change of Body Mass Index (BMI) Z-score for ToddlersToddlers BMI z-score at baseline0.49 z-scoreStandard Error 0.12
Maternal Lifestyle (Physical Activity and Nutrition)Change of Body Mass Index (BMI) Z-score for ToddlersToddler BMI z-score12-month follow-up0.52 z-scoreStandard Error 0.12
Responsive ParentingChange of Body Mass Index (BMI) Z-score for ToddlersToddlers BMI z-score at baseline0.50 z-scoreStandard Error 0.12
Responsive ParentingChange of Body Mass Index (BMI) Z-score for ToddlersToddler BMI z-score12-month follow-up0.61 z-scoreStandard Error 0.12
Child SafetyChange of Body Mass Index (BMI) Z-score for ToddlersToddlers BMI z-score at baseline0.62 z-scoreStandard Error 0.12
Child SafetyChange of Body Mass Index (BMI) Z-score for ToddlersToddler BMI z-score12-month follow-up0.57 z-scoreStandard Error 0.12
Comparison: 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.p-value: 0.55595% CI: [-0.17, 0.31]Mixed Models Analysis
p-value: 0.295% CI: [-0.08, 0.39]Mixed Models Analysis
Secondary

Change of Child Physical Activity

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Maternal Lifestyle (Physical Activity and Nutrition)Change of Child Physical ActivityToddler MVPA at baseline44.56 minutes per dayStandard Error 4.92
Maternal Lifestyle (Physical Activity and Nutrition)Change of Child Physical ActivityToddler MVPA at 12-month follow73.10 minutes per dayStandard Error 7.37
Responsive ParentingChange of Child Physical ActivityToddler MVPA at baseline52.39 minutes per dayStandard Error 4.98
Responsive ParentingChange of Child Physical ActivityToddler MVPA at 12-month follow71.05 minutes per dayStandard Error 7.13
Child SafetyChange of Child Physical ActivityToddler MVPA at baseline64.18 minutes per dayStandard Error 5.11
Child SafetyChange of Child Physical ActivityToddler MVPA at 12-month follow69.05 minutes per dayStandard Error 7.14
Comparison: Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.p-value: 0.03495% CI: [1.88, 45.46]Mixed Models Analysis
p-value: 0.21695% CI: [-7.98, 35.03]Mixed Models Analysis
Secondary

Change of Diet Quality for Mothers

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

Population: Mothers of toddlers

ArmMeasureGroupValue (MEAN)Dispersion
Maternal Lifestyle (Physical Activity and Nutrition)Change of Diet Quality for MothersBaseline HEI 201546.88 score on a scaleStandard Error 1.32
Maternal Lifestyle (Physical Activity and Nutrition)Change of Diet Quality for Mothers12-month HEI 201548.39 score on a scaleStandard Error 1.52
Responsive ParentingChange of Diet Quality for MothersBaseline HEI 201548.71 score on a scaleStandard Error 1.35
Responsive ParentingChange of Diet Quality for Mothers12-month HEI 201546.90 score on a scaleStandard Error 1.53
Child SafetyChange of Diet Quality for MothersBaseline HEI 201548.52 score on a scaleStandard Error 1.34
Child SafetyChange of Diet Quality for Mothers12-month HEI 201546.74 score on a scaleStandard Error 1.57
Comparison: Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.p-value: 0.18695% CI: [-1.6, 8.2]Mixed Models Analysis
Comparison: H0 is there is no difference in the change of maternal HEI score over time between the two groups.p-value: 0.9995% CI: [-4.97, 4.91]Mixed Models Analysis
Secondary

Change of Diet Quality for Toddlers

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Maternal Lifestyle (Physical Activity and Nutrition)Change of Diet Quality for ToddlersToddler HEI total at baseline52.44 units on a scaleStandard Error 1.18
Maternal Lifestyle (Physical Activity and Nutrition)Change of Diet Quality for ToddlersToddler HEI total at 12-month follow-up52.84 units on a scaleStandard Error 1.38
Responsive ParentingChange of Diet Quality for ToddlersToddler HEI total at baseline54.58 units on a scaleStandard Error 1.2
Responsive ParentingChange of Diet Quality for ToddlersToddler HEI total at 12-month follow-up52.49 units on a scaleStandard Error 1.36
Child SafetyChange of Diet Quality for ToddlersToddler HEI total at baseline55.1 units on a scaleStandard Error 1.19
Child SafetyChange of Diet Quality for ToddlersToddler HEI total at 12-month follow-up52.19 units on a scaleStandard Error 1.35
Comparison: H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.p-value: 0.16895% CI: [-1.4, 8.02]Mixed Models Analysis
Comparison: H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over timep-value: 0.73395% CI: [-3.88, 5.52]Mixed Models Analysis
Secondary

Change of Maternal Physical Activity

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Maternal Lifestyle (Physical Activity and Nutrition)Change of Maternal Physical ActivityMaternal MVPA at baseline23.10 minutes per dayStandard Error 2.06
Maternal Lifestyle (Physical Activity and Nutrition)Change of Maternal Physical ActivityMaternal MVPA at 12-month follow27.41 minutes per dayStandard Error 3.07
Responsive ParentingChange of Maternal Physical ActivityMaternal MVPA at 12-month follow20.42 minutes per dayStandard Error 3.21
Responsive ParentingChange of Maternal Physical ActivityMaternal MVPA at baseline26.11 minutes per dayStandard Error 2.17
Child SafetyChange of Maternal Physical ActivityMaternal MVPA at baseline27.76 minutes per dayStandard Error 2.17
Child SafetyChange of Maternal Physical ActivityMaternal MVPA at 12-month follow21.09 minutes per dayStandard Error 3.22
Comparison: H0 is that there is no difference in the change of maternal MVPA over time between the two groups.p-value: 0.02495% CI: [1.46, 20.48]Mixed Models Analysis
Comparison: H0 is that there is no significant difference in the change of maternal MVPA between the two groups.p-value: 0.80495% CI: [-8.76, 10.72]Mixed Models Analysis
Secondary

Feeding Style

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Maternal Lifestyle (Physical Activity and Nutrition)Feeding StyleMaternal feeding style at baseline4.69 score on a scaleStandard Error 0.11
Maternal Lifestyle (Physical Activity and Nutrition)Feeding StyleMaternal feeding style at 12-month5.07 score on a scaleStandard Error 0.14
Responsive ParentingFeeding StyleMaternal feeding style at baseline4.42 score on a scaleStandard Error 0.11
Responsive ParentingFeeding StyleMaternal feeding style at 12-month5.19 score on a scaleStandard Error 0.14
Child SafetyFeeding StyleMaternal feeding style at baseline4.71 score on a scaleStandard Error 0.12
Child SafetyFeeding StyleMaternal feeding style at 12-month5.46 score on a scaleStandard Error 0.13
Comparison: The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.p-value: 0.05695% CI: [-0.78, 0.06]Mixed Models Analysis
Comparison: The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.p-value: 0.89695% CI: [-0.39, 0.45]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026