Trial Outcomes & Findings for Toddler Overweight Prevention Study Among Low-Income Families (NCT NCT02615158)
NCT ID: NCT02615158
Last Updated: 2020-05-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
277 participants
Primary outcome timeframe
Baseline to 12-month Follow-up
Results posted on
2020-05-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
94
|
92
|
91
|
|
Overall Study
COMPLETED
|
73
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
21
|
16
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Toddler Overweight Prevention Study Among Low-Income Families
Baseline characteristics by cohort
| Measure |
Maternal Lifestyle (Physical Activity and Nutrition)
n=94 Participants
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.
|
Responsive Parenting
n=92 Participants
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.
|
Child Safety
n=91 Participants
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
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.17 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
27.53 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
28.16 years
STANDARD_DEVIATION 5.99 • n=5 Participants
|
27.28 years
STANDARD_DEVIATION 6.17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
277 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
92 participants
n=7 Participants
|
91 participants
n=5 Participants
|
277 participants
n=4 Participants
|
|
Maternal age
|
26.17 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
27.53 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
28.16 years
STANDARD_DEVIATION 5.99 • n=5 Participants
|
27.28 years
STANDARD_DEVIATION 6.17 • n=4 Participants
|
|
Household Poverty Ratio
|
68 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
|
Maternal Education
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Maternal Marital Status
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Location (Urban/Semi-Urban)
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Maternal BMI
|
31.98 kg/m^2
STANDARD_DEVIATION 9.48 • n=5 Participants
|
31.90 kg/m^2
STANDARD_DEVIATION 9.78 • n=7 Participants
|
31.51 kg/m^2
STANDARD_DEVIATION 9.24 • n=5 Participants
|
31.80 kg/m^2
STANDARD_DEVIATION 9.47 • n=4 Participants
|
|
Maternal dietary intake
|
2281 kcal/day
STANDARD_DEVIATION 745 • n=5 Participants
|
2214 kcal/day
STANDARD_DEVIATION 1053 • n=7 Participants
|
2033 kcal/day
STANDARD_DEVIATION 738 • n=5 Participants
|
2177 kcal/day
STANDARD_DEVIATION 859 • n=4 Participants
|
|
Maternal physical activity
|
23.22 Minutes Mod/Vig Activity/Day
STANDARD_DEVIATION 18.07 • n=5 Participants
|
26.14 Minutes Mod/Vig Activity/Day
STANDARD_DEVIATION 20.36 • n=7 Participants
|
27.52 Minutes Mod/Vig Activity/Day
STANDARD_DEVIATION 17.82 • n=5 Participants
|
25.54 Minutes Mod/Vig Activity/Day
STANDARD_DEVIATION 18.76 • n=4 Participants
|
|
Toddler age
|
19.98 months
STANDARD_DEVIATION 5.55 • n=5 Participants
|
20.22 months
STANDARD_DEVIATION 5.56 • n=7 Participants
|
20.14 months
STANDARD_DEVIATION 5.46 • n=5 Participants
|
20.11 months
STANDARD_DEVIATION 5.50 • n=4 Participants
|
|
Toddler sex
Females
|
48 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Toddler sex
Males
|
46 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Toddler race/ethnicity
Non-Hispanic African American
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Toddler race/ethnicity
Non-Hispanic White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Toddler race/ethnicity
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Toddler race/ethnicity
Mixed
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Toddler Body Mass Index (BMI) Z-score
|
0.49 Body mass index z-scores
STANDARD_DEVIATION 1.10 • n=5 Participants
|
0.51 Body mass index z-scores
STANDARD_DEVIATION 1.16 • n=7 Participants
|
0.63 Body mass index z-scores
STANDARD_DEVIATION 1.14 • n=5 Participants
|
0.54 Body mass index z-scores
STANDARD_DEVIATION 1.13 • n=4 Participants
|
|
Toddler dietary intake
|
1282 Total energy kcal/day
STANDARD_DEVIATION 476 • n=5 Participants
|
1297 Total energy kcal/day
STANDARD_DEVIATION 463 • n=7 Participants
|
1262 Total energy kcal/day
STANDARD_DEVIATION 419 • n=5 Participants
|
1281 Total energy kcal/day
STANDARD_DEVIATION 453 • n=4 Participants
|
|
Toddler physical activity
|
45.45 Minutes Mod/Vig physical activity/day
STANDARD_DEVIATION 38.53 • n=5 Participants
|
52.99 Minutes Mod/Vig physical activity/day
STANDARD_DEVIATION 35.87 • n=7 Participants
|
64.62 Minutes Mod/Vig physical activity/day
STANDARD_DEVIATION 45.16 • n=5 Participants
|
54.08 Minutes Mod/Vig physical activity/day
STANDARD_DEVIATION 40.43 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12-month Follow-upPopulation: Toddlers in low-income families, defined as WIC-eligible (income \< 185% of poverty index). WIC=Special Supplementary Program for Women, Infants, and Children.
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.
Outcome measures
| Measure |
Maternal Lifestyle (Physical Activity and Nutrition)
n=94 Participants
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.
|
Responsive Parenting
n=92 Participants
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.
|
Child Safety
n=91 Participants
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.
|
|---|---|---|---|
|
Change of Body Mass Index (BMI) Z-score for Toddlers
Toddlers BMI z-score at baseline
|
0.49 z-score
Standard Error 0.12
|
0.50 z-score
Standard Error 0.12
|
0.62 z-score
Standard Error 0.12
|
|
Change of Body Mass Index (BMI) Z-score for Toddlers
Toddler BMI z-score12-month follow-up
|
0.52 z-score
Standard Error 0.12
|
0.61 z-score
Standard Error 0.12
|
0.57 z-score
Standard Error 0.12
|
PRIMARY outcome
Timeframe: Baseline to 12 month Follow-upPopulation: Mothers of toddlers participating in study, low-income, defined as WIC-eligible.
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.
Outcome measures
| Measure |
Maternal Lifestyle (Physical Activity and Nutrition)
n=94 Participants
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.
|
Responsive Parenting
n=92 Participants
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.
|
Child Safety
n=91 Participants
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.
|
|---|---|---|---|
|
Change in Body Mass Index (BMI) Score Among Mothers
Maternal BMI at baseline
|
31.98 kg/m^2
Standard Deviation 0.98
|
31.90 kg/m^2
Standard Deviation 0.99
|
31.51 kg/m^2
Standard Deviation 0.99
|
|
Change in Body Mass Index (BMI) Score Among Mothers
Maternal BMI at 12-month follow-up
|
32.22 kg/m^2
Standard Deviation 0.99
|
32.21 kg/m^2
Standard Deviation 0.99
|
31.85 kg/m^2
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline to 12-month Follow-upPopulation: Change in HEI 2015 score for toddlers from baseline to 12 months
Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality.
Outcome measures
| Measure |
Maternal Lifestyle (Physical Activity and Nutrition)
n=94 Participants
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.
|
Responsive Parenting
n=92 Participants
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.
|
Child Safety
n=91 Participants
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.
|
|---|---|---|---|
|
Change of Diet Quality for Toddlers
Toddler HEI total at baseline
|
52.44 units on a scale
Standard Error 1.18
|
54.58 units on a scale
Standard Error 1.20
|
55.1 units on a scale
Standard Error 1.19
|
|
Change of Diet Quality for Toddlers
Toddler HEI total at 12-month follow-up
|
52.84 units on a scale
Standard Error 1.38
|
52.49 units on a scale
Standard Error 1.36
|
52.19 units on a scale
Standard Error 1.35
|
SECONDARY outcome
Timeframe: Baseline to 12-month Follow-upPopulation: Mothers of toddlers
Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal
Outcome measures
| Measure |
Maternal Lifestyle (Physical Activity and Nutrition)
n=94 Participants
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.
|
Responsive Parenting
n=92 Participants
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.
|
Child Safety
n=91 Participants
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.
|
|---|---|---|---|
|
Change of Diet Quality for Mothers
Baseline HEI 2015
|
46.88 score on a scale
Standard Error 1.32
|
48.71 score on a scale
Standard Error 1.35
|
48.52 score on a scale
Standard Error 1.34
|
|
Change of Diet Quality for Mothers
12-month HEI 2015
|
48.39 score on a scale
Standard Error 1.52
|
46.90 score on a scale
Standard Error 1.53
|
46.74 score on a scale
Standard Error 1.57
|
SECONDARY outcome
Timeframe: Baseline to 12-month Follow-upPopulation: Toddlers who participated in the trial, from low-income families, defined as WIC-eligible
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.
Outcome measures
| Measure |
Maternal Lifestyle (Physical Activity and Nutrition)
n=94 Participants
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.
|
Responsive Parenting
n=92 Participants
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.
|
Child Safety
n=91 Participants
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.
|
|---|---|---|---|
|
Change of Child Physical Activity
Toddler MVPA at baseline
|
44.56 minutes per day
Standard Error 4.92
|
52.39 minutes per day
Standard Error 4.98
|
64.18 minutes per day
Standard Error 5.11
|
|
Change of Child Physical Activity
Toddler MVPA at 12-month follow
|
73.10 minutes per day
Standard Error 7.37
|
71.05 minutes per day
Standard Error 7.13
|
69.05 minutes per day
Standard Error 7.14
|
SECONDARY outcome
Timeframe: Baseline-12 month follow upPopulation: Change in the number of steps per day from baseline to 12-month follow-up in MVPA
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.
Outcome measures
| Measure |
Maternal Lifestyle (Physical Activity and Nutrition)
n=94 Participants
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.
|
Responsive Parenting
n=92 Participants
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.
|
Child Safety
n=91 Participants
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.
|
|---|---|---|---|
|
Change of Maternal Physical Activity
Maternal MVPA at baseline
|
23.10 minutes per day
Standard Error 2.06
|
26.11 minutes per day
Standard Error 2.17
|
27.76 minutes per day
Standard Error 2.17
|
|
Change of Maternal Physical Activity
Maternal MVPA at 12-month follow
|
27.41 minutes per day
Standard Error 3.07
|
20.42 minutes per day
Standard Error 3.21
|
21.09 minutes per day
Standard Error 3.22
|
SECONDARY outcome
Timeframe: Baseline to 12 month Follow-upPopulation: Change in Emotional Availability Scale scores from 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.
Outcome measures
| Measure |
Maternal Lifestyle (Physical Activity and Nutrition)
n=94 Participants
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.
|
Responsive Parenting
n=92 Participants
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.
|
Child Safety
n=91 Participants
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.
|
|---|---|---|---|
|
Feeding Style
Maternal feeding style at baseline
|
4.69 score on a scale
Standard Error 0.11
|
4.42 score on a scale
Standard Error 0.11
|
4.71 score on a scale
Standard Error 0.12
|
|
Feeding Style
Maternal feeding style at 12-month
|
5.07 score on a scale
Standard Error 0.14
|
5.19 score on a scale
Standard Error 0.14
|
5.46 score on a scale
Standard Error 0.13
|
Adverse Events
Maternal Lifestyle (Physical Activity and Nutrition)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Responsive Parenting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Child Safety
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Maureen Black
University of Maryland School of Medicine
Phone: 410-706-2136
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place