Trial Outcomes & Findings for Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR) (NCT NCT05020366)
NCT ID: NCT05020366
Last Updated: 2024-07-15
Results Overview
As measured using interventionist documentation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 months
Results posted on
2024-07-15
Participant Flow
Protocol Enrollment reflects the number of individual children and parents enrolled \[40\], but data are reported in the Results Section per family unit \[20\], except where otherwise noted \[Adverse Events\].
Participant milestones
| Measure |
Pro-PEAR
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Promoting Health through Parent Empowerment and the Activation of Routines: Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
|
Overall Study
COMPLETED
|
11
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Pro-PEAR
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Promoting Health through Parent Empowerment and the Activation of Routines: Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Two parents did not provide age data. Only those with age data were included in this report.
Baseline characteristics by cohort
| Measure |
Pro-PEAR
n=15 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=5 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 3.7 • n=13 Participants • Two parents did not provide age data. Only those with age data were included in this report.
|
34.4 years
STANDARD_DEVIATION 6.0 • n=5 Participants • Two parents did not provide age data. Only those with age data were included in this report.
|
35.2 years
STANDARD_DEVIATION 4.3 • n=18 Participants • Two parents did not provide age data. Only those with age data were included in this report.
|
|
Sex: Female, Male
Child Participants · Female
|
6 Participants
n=15 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Child Participants · Male
|
9 Participants
n=15 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Parent Participants · Female
|
14 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=20 Participants
|
|
Sex: Female, Male
Parent Participants · Male
|
1 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Child Participants · Hispanic or Latino
|
2 Participants
n=15 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Child Participants · Not Hispanic or Latino
|
13 Participants
n=15 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Child Participants · Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Parent Participants · Hispanic or Latino
|
1 Participants
n=15 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Parent Participants · Not Hispanic or Latino
|
14 Participants
n=15 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Parent Participants · Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Child Participants · American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Child Participants · Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Child Participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Child Participants · Black or African American
|
2 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Child Participants · White
|
9 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Child Participants · More than one race
|
3 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Child Participants · Unknown or Not Reported
|
1 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Parent Participants · American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Parent Participants · Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Parent Participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Parent Participants · Black or African American
|
1 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Parent Participants · White
|
12 Participants
n=15 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Parent Participants · More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Parent Participants · Unknown or Not Reported
|
2 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: In this analysis, we only included participants (both children and parents) who attended at least 1 intervention session (e.g., not those lost to follow-up prior to intervention and not those in the control group.
As measured using interventionist documentation
Outcome measures
| Measure |
Pro-PEAR
n=14 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Number of Pro-PEAR Intervention Sessions Completed
|
9.1 # of sessions completed
Standard Deviation 2.3
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The TAQ was sent separately only to parent participants who received the intervention. Not all parent participants who received this web-based survey completed it.
Participant acceptability ratings of the PrO-PEAR intervention using the Treatment Acceptability Questionnaire. Scores range from 8 to 48 with higher scores indicating higher acceptability.
Outcome measures
| Measure |
Pro-PEAR
n=8 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Parent-reported Intervention Acceptability as Rated on a Likert Scale.
|
38.8 score on a scale
Standard Deviation 6.8
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: We calculated the number of outcomes collected across participants in the intervention and control groups and calculated percentage of assessments collected.
Measured by the number of outcomes collected divided by the number of planned outcomes
Outcome measures
| Measure |
Pro-PEAR
n=450 Planned Assessments
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=150 Planned Assessments
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Percentage of Planned Data Collection Efforts Completed Successfully
|
80 percentage of assessments collected
|
94 percentage of assessments collected
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Participant families were randomized to groups after recruitment - we report this data based on family units.
Quantified for each month of active recruitment and averaged
Outcome measures
| Measure |
Pro-PEAR
n=20 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
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|---|---|---|
|
Number of Participant Families Recruited Per Month
|
5.25 participant families per month
|
—
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: We only used outcomes on child participants with complete data at baseline and 3 months.
change in # of fruits \& vegetables children consumed, on average, each day as measured by parent report and the EAT FFQ (Eating Assessment in Toddlers Food Frequency Questionnaire). Average number of portions of fruits and vegetables were reported on two questions of a Food Frequency Questionnaire with options ranging from 0-4 servings of fruits and 0-4 servings of vegetables. These scores were added together at each time point with greater scores indicating greater consumption of fruits and vegetables.
Outcome measures
| Measure |
Pro-PEAR
n=12 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=5 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Healthy Eating From Baseline to 3 Months
|
0.33 change score on a scale
Standard Deviation 1.03
|
0.2 change score on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: We only analyzed child participants with complete data at baseline and 6 months on this measure.
change in # of fruits \& vegetables children consumed, on average, each day as measured by parent report and the EAT FFQ (Eating Assessment in Toddlers Food Frequency Questionnaire). Average number of portions of fruits and vegetables were reported on two questions of a Food Frequency Questionnaire with options ranging from 0-4 servings of fruits and 0-4 servings of vegetables. These scores were added together at each time point with greater scores indicating greater consumption of fruits and vegetables.
Outcome measures
| Measure |
Pro-PEAR
n=9 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=5 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Healthy Eating From Baseline to 6 Months
|
0.11 change score on a scale
Standard Deviation 1.52
|
-0.2 change score on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: We only analyzed data on child participants with data on physical activity at baseline and 3 months.
change in # of hours of light, moderate, or vigorous child physical activity, on average, each day as measured by activPAL
Outcome measures
| Measure |
Pro-PEAR
n=9 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=3 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Physical Activity From Baseline to 3 Months
|
0.45 hours
Standard Deviation 1.97
|
0.01 hours
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: We only analyzed data on child participants with complete physical activity data at baseline and 6 months.
change in # of hours of light, moderate, or vigorous child physical activity, on average, each day as measured by activPAL
Outcome measures
| Measure |
Pro-PEAR
n=8 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=4 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Physical Activity From Baseline to 6 Months
|
0.32 hours
Standard Deviation 1.35
|
1.33 hours
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: Only child participants with complete data for sedentary behavior (activPAL) at baseline and 3 months were included.
change in # of minutes spent in bouts of sedentary behavior \>60 minutes, on average, each day as measured by activPAL (Physical Activities Logging)
Outcome measures
| Measure |
Pro-PEAR
n=8 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=3 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Sedentary Behavior From Baseline to 3 Months
|
21.01 minutes
Standard Deviation 73.35
|
11.66 minutes
Standard Deviation 31.93
|
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: Only child participants with complete data for sedentary behavior (activPAL) at baseline and 6 months were included.
change in # minutes of bouts of sedentary behavior \>60 minutes, on average, each day as measured by activPAL
Outcome measures
| Measure |
Pro-PEAR
n=7 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=3 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Sedentary Behavior From Baseline to 6 Months
|
-32.54 minutes
Standard Deviation 70.52
|
-54.45 minutes
Standard Deviation 38.16
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: We only included child participants with data for sleep (Actiwatch) at baseline and 3 months.
change in # minutes of child sleep, on average, each night as measured by the Phillips Actiwatch
Outcome measures
| Measure |
Pro-PEAR
n=11 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=5 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Sleep Duration From Baseline to 3 Months
|
13.50 minutes
Standard Deviation 50.03
|
9.68 minutes
Standard Deviation 34.00
|
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: Only child participants who had sleep (Actiwatch) data at baseline and 6 months were included.
change in # minutes of child sleep, on average, each night as measured by the Phillips Actiwatch
Outcome measures
| Measure |
Pro-PEAR
n=8 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=5 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Sleep Duration From Baseline to 6 Months
|
19.26 minutes
Standard Deviation 52.02
|
21.12 minutes
Standard Deviation 18.11
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SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: We only analyzed child participants with complete data on weight at baseline and 6 months.
Child weight will be assessed using chart review and scale
Outcome measures
| Measure |
Pro-PEAR
n=9 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=5 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Child Weight From Baseline to 6 Months
|
4.40 pounds
Standard Deviation 0.74
|
3.38 pounds
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: We only analyzed child participants with complete height data at baseline and 6 months.
Child weight will be assessed using chart review and scale
Outcome measures
| Measure |
Pro-PEAR
n=9 Participants
This group will receive the optimized Pro-PEAR intervention (in addition to usual care).
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=3 Participants
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
|
Change in Child Height From Baseline to 6 Months
|
3.78 inches
Standard Deviation 4.13
|
4.84 inches
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: 1 yearPopulation: We were unable to collect this data because we could not gain access to participant's charts throughout the conduct of this study.
Child weight will be assessed using chart review.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one yearPopulation: We were unable to collect height at one year because we were not able to gain access to participant's medical chart throughout the conduct of this study.
Child height will be assessed using chart review.
Outcome measures
Outcome data not reported
Adverse Events
PrO-PEAR
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PrO-PEAR
n=30 participants at risk
This group will receive the optimized PrO-PEAR intervention (in addition to usual care).
Preventing Obesity through Parent Empowerment and the Activation of Routines: Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
|
Enhanced Usual Care
n=10 participants at risk
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.
Enhanced Usual Care: For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
|
|---|---|---|
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Skin and subcutaneous tissue disorders
skin irritation
|
3.3%
1/30 • Number of events 1 • 6 months
Participants were encouraged to report adverse events experienced as part of data collection. We are reporting on adverse events reported for child and parent participants.
|
0.00%
0/10 • 6 months
Participants were encouraged to report adverse events experienced as part of data collection. We are reporting on adverse events reported for child and parent participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place