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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD056099 | U.S. NIH Grant/Contract | View source | |
| R03HD077156 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maternal Physical Activity and Nutrition | Experimental | A maternal intervention focusing on healthy diet and physical activity patterns for mothers. |
|
| Parenting | Experimental | A toddler parenting intervention focusing on parenting, limit setting, and development strategies. |
|
| Child Safety | Experimental | Attention control group. The parents received intervention to promote safety among toddlers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maternal Physical Activity and Nutrition | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12-month Follow-up |
| 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. | Baseline to 12 month Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12-month Follow-up |
| Change of Diet Quality for Mothers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen M Black, PhD | University of Maryland, College Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, School of Medicine | Baltimore | Maryland | 21201 | United States | ||
| University of Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16595758 | Background | 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. doi: 10.1001/jama.295.13.1549. | |
| 33752659 | Derived | Campbell KL, Wang Y, Kuhn AP, Black MM, Hager ER. An ecological momentary assessment study of physical activity behaviors among mothers of toddlers from low-income households. BMC Womens Health. 2021 Mar 22;21(1):120. doi: 10.1186/s12905-021-01243-2. |
| Label | URL |
|---|---|
| Study Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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. | Toddlers in low-income families, defined as WIC-eligible (income < 185% of poverty index). WIC=Special Supplementary Program for Women, Infants, and Children. | Posted | Mean | Standard Error | z-score | Baseline to 12-month Follow-up |
|
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).
Data Safety Monitoring Committee reviewed records and interviewed project coordinator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Data analysis was delayed due to extended period of time for coding the mother-toddler interaction data, related to personnel and funding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maureen Black | University of Maryland School of Medicine | 410-706-2136 | mblack@som.umaryland.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003863 | Depression |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D011581 | Psychological Tests |
| D057207 | Child Restraint Systems |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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|
| Parenting | Behavioral | 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. |
|
| Child Safety | Behavioral | 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. |
|
Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal
| Baseline to 12-month Follow-up |
| 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. | Baseline to 12-month Follow-up |
| 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. | Baseline-12 month follow up |
| 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. | Baseline to 12 month Follow-up |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| 33196078 | Derived | Covington L, Armstrong B, Trude ACB, Black MM. Longitudinal Associations Among Diet Quality, Physical Activity and Sleep Onset Consistency With Body Mass Index z-Score Among Toddlers in Low-income Families. Ann Behav Med. 2021 Jun 28;55(7):653-664. doi: 10.1093/abm/kaaa100. |
| 32885909 | Derived | Black MM, Hager ER, Wang Y, Hurley KM, Latta LW, Candelaria M, Caulfield LE. Toddler obesity prevention: A two-generation randomized attention-controlled trial. Matern Child Nutr. 2021 Jan;17(1):e13075. doi: 10.1111/mcn.13075. Epub 2020 Sep 4. |
| 31171491 | Derived | Armstrong B, Covington LB, Hager ER, Black MM. Objective sleep and physical activity using 24-hour ankle-worn accelerometry among toddlers from low-income families. Sleep Health. 2019 Oct;5(5):459-465. doi: 10.1016/j.sleh.2019.04.005. Epub 2019 Jun 3. |
| 28385953 | Derived | Wang Y, Gielen AC, Magder LS, Hager ER, Black MM. A randomised safety promotion intervention trial among low-income families with toddlers. Inj Prev. 2018 Feb;24(1):41-47. doi: 10.1136/injuryprev-2016-042178. Epub 2017 Apr 6. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Maternal age | Mean | Standard Deviation | years |
|
| Household Poverty Ratio | Household poverty ratio was calculated based on the federal poverty threshold for the year the data were collected using mother-reported total family income and number of household members. We summed the number of families with poverty ratio below 1, indicating that the average income for the family size is below the official definition of poverty. | Count of Participants | Participants |
|
| Maternal Education | We calculated the number of mothers who had completed high school or the General Educational Development (GED) test. | Count of Participants | Participants |
|
| Maternal Marital Status | Count of the number of mothers who were married | Count of Participants | Participants |
|
| Location (Urban/Semi-Urban) | Families were recruited from 2 sites: urban and semi-urban. We counted the number of mothers from the urban site | Count of Participants | Participants |
|
| Maternal BMI | Weight and height are measured to calculate BMI (kg/m^2). | Mean | Standard Deviation | kg/m^2 |
|
| Maternal dietary intake | Mean | Standard Deviation | kcal/day |
|
| Maternal physical activity | Mean | Standard Deviation | Minutes Mod/Vig Activity/Day |
|
| Toddler age | Mean | Standard Deviation | months |
|
| Toddler sex | Count of Participants | Participants |
|
| Toddler race/ethnicity | Count of Participants | Participants |
|
| Toddler Body Mass Index (BMI) Z-score | Body Mass Index, kg/m^2, is calculated by measured weight and height. BMI z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. These scores are used to determine weight status (e.g., overweight, obese, etc.) | Mean | Standard Deviation | Body mass index z-scores |
|
| Toddler dietary intake | Mean | Standard Deviation | Total energy kcal/day |
|
| Toddler physical activity | Mean | Standard Deviation | Minutes Mod/Vig physical activity/day |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| 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. | Mothers of toddlers participating in study, low-income, defined as WIC-eligible. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to 12 month Follow-up |
|
|
|
|
| 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. | Change in HEI 2015 score for toddlers from baseline to 12 months | Posted | Mean | Standard Error | units on a scale | Baseline to 12-month Follow-up |
|
|
|
|
| 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 | Mothers of toddlers | Posted | Mean | Standard Error | score on a scale | Baseline to 12-month Follow-up |
|
|
|
|
| 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. | Toddlers who participated in the trial, from low-income families, defined as WIC-eligible | Posted | Mean | Standard Error | minutes per day | Baseline to 12-month Follow-up |
|
|
|
|
| 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. | Change in the number of steps per day from baseline to 12-month follow-up in MVPA | Posted | Mean | Standard Error | minutes per day | Baseline-12 month follow up |
|
|
|
|
| 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. | Change in Emotional Availability Scale scores from baseline to 12-month follow-up | Posted | Mean | Standard Error | score on a scale | Baseline to 12 month Follow-up |
|
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | 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. | 0 | 92 | 0 | 92 | 0 | 92 |
| EG002 | 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. | 0 | 91 | 0 | 91 | 0 | 91 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D004191 | Behavioral Disciplines and Activities |
| D015370 | Infant Equipment |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
|
| H0: There are no differences in the change over time between responsive parenting and child safety groups. | Mixed Models Analysis | 0.904 | The alpha for statistical significance was set at 0.05. | Slope | -0.04 | Standard Error of the Mean | 0.32 | 2-Sided | 95 | -0.66 | 0.59 | This is to compare the responsive parenting group to the child safety group. | Equivalence | 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. |
|
| H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time | Mixed Models Analysis | 0.733 | Slope | 0.82 | Standard Error of the Mean | 2.39 | 2-Sided | 95 | -3.88 | 5.52 | This is to compare the responsive feeding group to child safety group. | Equivalence | 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. |
|
| H0 is there is no difference in the change of maternal HEI score over time between the two groups. | Mixed Models Analysis | 0.990 | Alpha is set to 0.05. | Slope | -0.03 | Standard Error of the Mean | 2.51 | 2-Sided | 95 | -4.97 | 4.91 | This is to compare the responsive parenting group to child safety group. | Equivalence | 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. |
|
| Mixed Models Analysis | 0.216 | Slope | 13.52 | Standard Error of the Mean | 10.89 | 2-Sided | 95 | -7.98 | 35.03 | This is to compare the responsive parenting group to child safety group. | Equivalence | H0 is that there is no difference between the change of MVPA over time between the two groups. |
|
| H0 is that there is no significant difference in the change of maternal MVPA between the two groups. | Mixed Models Analysis | 0.804 | Slope | 0.98 | Standard Error of the Mean | 4.94 | 2-Sided | 95 | -8.76 | 10.72 | This is to compare responsive parenting group to child safety group. | Equivalence | The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference. |
|
| The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference. | Mixed Models Analysis | 0.896 | Slope | 0.03 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -0.39 | 0.45 | This is to compare responsive parenting group to child safety group. | Equivalence | Alpha is set at 0.05 to indicate statistical significance. |