Trial Outcomes & Findings for In-home Obesity Prevention to Reach Low-income Infants (NCT NCT03529695)
NCT ID: NCT03529695
Last Updated: 2024-10-23
Results Overview
Body mass index (BMI) at each assessment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
Baseline, 6 months, 12 months
Results posted on
2024-10-23
Participant Flow
Mother-child dyads were recruited into the study. Home visitors who delivered the program in the intervention and control arms were not enrolled into the study.
The enrollment number represents the number of mother-infant dyads.
Participant milestones
| Measure |
Standard HVP Curriculum- Mothers
Mother and their children participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Mothers
Mother and their children participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
Mother and their children participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
Mother and their children participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
42
|
35
|
42
|
|
Overall Study
COMPLETED
|
20
|
22
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
15
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In-home Obesity Prevention to Reach Low-income Infants
Baseline characteristics by cohort
| Measure |
Standard HVP Curriculum-Mothers
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention-Mothers
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum-Children
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention-Children
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.7 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
29.7 Years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
0.875 Years
STANDARD_DEVIATION 0.625 • n=5 Participants
|
0.825 Years
STANDARD_DEVIATION 0.767 • n=4 Participants
|
15.05 Years
STANDARD_DEVIATION 3.80 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Some participants did not compete all study assessments.
Body mass index (BMI) at each assessment
Outcome measures
| Measure |
Standard HVP Curriculum
n=31 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=40 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Mother BMI
Baseline
|
30.6 kg/m^2
Standard Deviation 8.1
|
34.2 kg/m^2
Standard Deviation 9.5
|
—
|
—
|
|
Mother BMI
6 Month
|
34 kg/m^2
Standard Deviation 8.7
|
34.3 kg/m^2
Standard Deviation 9.8
|
—
|
—
|
|
Mother BMI
12 Month
|
32 kg/m^2
Standard Deviation 9.6
|
35.4 kg/m^2
Standard Deviation 10
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Missing data
weight in pounds
Outcome measures
| Measure |
Standard HVP Curriculum
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Infant Weight
Baseline
|
20.0 pounds
Standard Deviation 5.7
|
19.3 pounds
Standard Deviation 6.5
|
—
|
—
|
|
Infant Weight
6 Month
|
24.2 pounds
Standard Deviation 5.6
|
22.1 pounds
Standard Deviation 3.3
|
—
|
—
|
|
Infant Weight
12 Months
|
30.3 pounds
Standard Deviation 10.1
|
28.9 pounds
Standard Deviation 5.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsAssessed using modified food frequency measures from the National Health and Nutrition Examination Survey (NHANES).
Outcome measures
| Measure |
Standard HVP Curriculum
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Fruit Intake Frequency
Baseline · Less than once a week
|
7 Participants
|
3 Participants
|
13 Participants
|
21 Participants
|
|
Fruit Intake Frequency
Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Fruit Intake Frequency
6 months · Less than once a week
|
4 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Fruit Intake Frequency
6 months · 1 to 6 times a week
|
12 Participants
|
13 Participants
|
6 Participants
|
8 Participants
|
|
Fruit Intake Frequency
6 months · Missing
|
10 Participants
|
17 Participants
|
10 Participants
|
19 Participants
|
|
Fruit Intake Frequency
12 months · Less than once a week
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Fruit Intake Frequency
12 months · 1 to 6 times a week
|
11 Participants
|
9 Participants
|
10 Participants
|
6 Participants
|
|
Fruit Intake Frequency
Baseline · 1 to 6 times a week
|
11 Participants
|
17 Participants
|
10 Participants
|
6 Participants
|
|
Fruit Intake Frequency
Baseline · 1 or more times a day
|
16 Participants
|
22 Participants
|
11 Participants
|
15 Participants
|
|
Fruit Intake Frequency
6 months · 1 or more times a day
|
8 Participants
|
7 Participants
|
17 Participants
|
13 Participants
|
|
Fruit Intake Frequency
12 months · 1 or more times a day
|
7 Participants
|
10 Participants
|
10 Participants
|
16 Participants
|
|
Fruit Intake Frequency
12 months · Missing
|
14 Participants
|
20 Participants
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsAssessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Outcome measures
| Measure |
Standard HVP Curriculum
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Vegetable Intake Frequency
Baseline · Less than once a week
|
7 Participants
|
4 Participants
|
13 Participants
|
21 Participants
|
|
Vegetable Intake Frequency
Baseline · 1 or more times a day
|
11 Participants
|
23 Participants
|
11 Participants
|
15 Participants
|
|
Vegetable Intake Frequency
12 months · Missing
|
14 Participants
|
20 Participants
|
14 Participants
|
20 Participants
|
|
Vegetable Intake Frequency
Baseline · 1 to 6 times a week
|
16 Participants
|
15 Participants
|
10 Participants
|
6 Participants
|
|
Vegetable Intake Frequency
Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Vegetable Intake Frequency
6 months · Less than once a week
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Vegetable Intake Frequency
6 months · 1 to 6 times a week
|
12 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
|
Vegetable Intake Frequency
6 months · 1 or more times a day
|
8 Participants
|
10 Participants
|
14 Participants
|
14 Participants
|
|
Vegetable Intake Frequency
6 months · Missing
|
10 Participants
|
18 Participants
|
10 Participants
|
17 Participants
|
|
Vegetable Intake Frequency
12 months · Less than once a week
|
3 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Vegetable Intake Frequency
12 months · 1 to 6 times a week
|
11 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
|
Vegetable Intake Frequency
12 months · 1 or more times a day
|
6 Participants
|
9 Participants
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsAssessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Outcome measures
| Measure |
Standard HVP Curriculum
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Fried Food Intake Frequency
6 months · 1 or more times a day
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Fried Food Intake Frequency
6 months · Missing
|
10 Participants
|
17 Participants
|
10 Participants
|
17 Participants
|
|
Fried Food Intake Frequency
12 months · 1 to 6 times a week
|
9 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
|
Fried Food Intake Frequency
12 months · 1 or more times a day
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Fried Food Intake Frequency
12 months · Missing
|
14 Participants
|
20 Participants
|
14 Participants
|
20 Participants
|
|
Fried Food Intake Frequency
Baseline · Less than once a week
|
16 Participants
|
19 Participants
|
27 Participants
|
36 Participants
|
|
Fried Food Intake Frequency
Baseline · 1 to 6 times a week
|
12 Participants
|
17 Participants
|
6 Participants
|
3 Participants
|
|
Fried Food Intake Frequency
Baseline · 1 or more times a day
|
6 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Fried Food Intake Frequency
Baseline · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Fried Food Intake Frequency
6 months · Less than once a week
|
10 Participants
|
9 Participants
|
19 Participants
|
21 Participants
|
|
Fried Food Intake Frequency
6 months · 1 to 6 times a week
|
10 Participants
|
11 Participants
|
5 Participants
|
4 Participants
|
|
Fried Food Intake Frequency
12 months · Less than once a week
|
10 Participants
|
14 Participants
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsAssessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Outcome measures
| Measure |
Standard HVP Curriculum
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Soda Intake Frequency
Baseline · Less than once a week
|
20 Participants
|
21 Participants
|
31 Participants
|
42 Participants
|
|
Soda Intake Frequency
12 months · Missing
|
15 Participants
|
20 Participants
|
15 Participants
|
20 Participants
|
|
Soda Intake Frequency
Baseline · 1 to 6 times a week
|
9 Participants
|
16 Participants
|
2 Participants
|
0 Participants
|
|
Soda Intake Frequency
Baseline · 1 or more times a day
|
5 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Soda Intake Frequency
Baseline · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Soda Intake Frequency
6 months · Less than once a week
|
15 Participants
|
15 Participants
|
22 Participants
|
24 Participants
|
|
Soda Intake Frequency
6 months · 1 to 6 times a week
|
7 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
|
Soda Intake Frequency
6 months · 1 or more times a day
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Soda Intake Frequency
6 months · Missing
|
10 Participants
|
17 Participants
|
10 Participants
|
17 Participants
|
|
Soda Intake Frequency
12 months · Less than once a week
|
12 Participants
|
18 Participants
|
19 Participants
|
21 Participants
|
|
Soda Intake Frequency
12 months · 1 to 6 times a week
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Soda Intake Frequency
12 months · 1 or more times a day
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsAssessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Outcome measures
| Measure |
Standard HVP Curriculum
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Fruit Juice Intake Frequency
Baseline · Less than once a week
|
18 Participants
|
12 Participants
|
24 Participants
|
32 Participants
|
|
Fruit Juice Intake Frequency
Baseline · 1 to 6 times a week
|
10 Participants
|
22 Participants
|
7 Participants
|
5 Participants
|
|
Fruit Juice Intake Frequency
Baseline · 1 or more times a day
|
6 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Fruit Juice Intake Frequency
Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Fruit Juice Intake Frequency
6 months · Less than once a week
|
10 Participants
|
12 Participants
|
11 Participants
|
15 Participants
|
|
Fruit Juice Intake Frequency
6 months · 1 to 6 times a week
|
8 Participants
|
10 Participants
|
9 Participants
|
6 Participants
|
|
Fruit Juice Intake Frequency
6 months · 1 or more times a day
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Fruit Juice Intake Frequency
6 months · Missing
|
10 Participants
|
17 Participants
|
10 Participants
|
17 Participants
|
|
Fruit Juice Intake Frequency
12 months · Less than once a week
|
15 Participants
|
8 Participants
|
11 Participants
|
7 Participants
|
|
Fruit Juice Intake Frequency
12 months · 1 to 6 times a week
|
3 Participants
|
9 Participants
|
6 Participants
|
10 Participants
|
|
Fruit Juice Intake Frequency
12 months · 1 or more times a day
|
2 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Fruit Juice Intake Frequency
12 months · Missing
|
14 Participants
|
20 Participants
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsAssessed using modified activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Outcome measures
| Measure |
Standard HVP Curriculum
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Mother Movement Frequency
Baseline · 3 to 7 times a day
|
13 Participants
|
12 Participants
|
—
|
—
|
|
Mother Movement Frequency
Baseline · 8 or more times a day
|
10 Participants
|
17 Participants
|
—
|
—
|
|
Mother Movement Frequency
Baseline · Missing
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Mother Movement Frequency
6 months · 2 times a day or less
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Mother Movement Frequency
6 months · Missing
|
14 Participants
|
20 Participants
|
—
|
—
|
|
Mother Movement Frequency
12 months · 2 times a day or less
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Mother Movement Frequency
12 months · 3 to 7 times a day
|
8 Participants
|
10 Participants
|
—
|
—
|
|
Mother Movement Frequency
12 months · 8 or more times a day
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Mother Movement Frequency
12 months · Missing
|
14 Participants
|
21 Participants
|
—
|
—
|
|
Mother Movement Frequency
Baseline · 2 times a day or less
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Mother Movement Frequency
6 months · 3 to 7 times a day
|
10 Participants
|
9 Participants
|
—
|
—
|
|
Mother Movement Frequency
6 months · 8 or more times a day
|
6 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsAssessed using modified food and activity frequency measures from the National Health and Nutrition Examination Survey (NHANES)
Outcome measures
| Measure |
Standard HVP Curriculum
n=34 Participants
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention
n=42 Participants
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum - Children
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention - Children
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: The content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Frequency of Infant Supervised Active Movement (Activity)
Baseline · Less than once a week
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
Baseline · 1 to 6 times a week
|
6 Participants
|
11 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
Baseline · 1 or 2 times a day
|
5 Participants
|
9 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
Baseline · 3 or more times a day
|
19 Participants
|
13 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
Baseline · Missing
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
6 months · Less than once a week
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
6 months · 1 to 6 times a week
|
2 Participants
|
8 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
6 months · 1 or 2 times a day
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
6 months · 3 or more times a day
|
13 Participants
|
10 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
6 months · Missing
|
14 Participants
|
20 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
12 months · Less than once a week
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
12 months · 1 to 6 times a week
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
12 months · 1 or 2 times a day
|
10 Participants
|
14 Participants
|
—
|
—
|
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Frequency of Infant Supervised Active Movement (Activity)
12 months · 3 or more times a day
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Frequency of Infant Supervised Active Movement (Activity)
12 months · Missing
|
14 Participants
|
20 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsThe U.S. Adult Food Security Survey Module will be used to evaluate hunger and food sufficiency to meet the basic needs of families.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsMeasured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for social isolation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsMeasured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for instrumental support.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsMeasured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form scale for emotional support.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsThe characteristics of the social actors (people) and relationships that surround mothers will be assessed using egocentric social network methods and social network analysis (SNA) to compute the health behavior and weight norms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsThe characteristics of the social actors (people, organizations) and relationships that surround mothers will be assessed using egocentric social network methods and social network analysis (SNA) to compute the density of relationships that provide health-related social support.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsHousehold environment assessing availability, accessibility, and visibility of activity items will be assessed using a modified Home Food Assessment (HFA) and Home - Inventory Describing Eating and Activity Development (H-IDEA), relating to the target activity behaviors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsHousehold environment assessing availability, accessibility, and visibility of food items will be assessed using a modified Home Food Assessment (HFA) and Home - Inventory Describing Eating and Activity Development (H-IDEA), relating to the target eating behaviors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsHabit strength will be assessed using the Self-Reported Habit Index (SRHI) specific to target eating and activity behaviors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineSelf-reported demographic history (gender, age, race, household income, etc) will be collected. Acculturation is measured using the Demographic Index of Cultural Exposure (DICE).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsSelf-reported medical history (prescription medications, child and parent/caregiver illnesses, etc.) will be collected
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsThe Edinburgh Postnatal Depression Scale (EPDS) will be used to determine maternal depression. Each of the 10 items has 4 optional responses with a set coding frame. Scores are summed and can range from 0 to 30. Values over 11 are indicative of risk for postnatal depression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 monthsBlood pressure will be collected prior to all blood draws
Outcome measures
Outcome data not reported
Adverse Events
Standard HVP Curriculum-Mothers
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Obesity Prevention-Mothers
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard HVP Curriculum-Children
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Obesity Prevention-Children
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard HVP Curriculum-Mothers
n=35 participants at risk
Participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention-Mothers
n=42 participants at risk
Participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
Standard HVP Curriculum-Children
n=35 participants at risk
Child participants will receive the standard Healthy Families America (HFA) home visitation curriculum delivered by trained home visitors. The HFA model meets the Department of Health and Human Services criteria for an "evidence-based early childhood home visiting service delivery model". HFA services begin prenatally and continue until children are 2-5yo. The curriculum focuses on strengthening parent-child relationships and family functioning, promoting positive child development, and linkage to community resources. Accredited home visitors are matched to families on cultural background and language, to provide culturally sensitive services. Home visitors receive weekly supervision, ongoing developmental training, and have limited caseloads (10-15 families) to meet their families' needs.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
|
Obesity Prevention-Children
n=42 participants at risk
Child participants will receive the standard Healthy Families America home visitation curriculum with the obesity prevention enhancement module, delivered by trained home visitors. Families are matched to home visitors based on their ethnicity/race and language preferences. The obesity prevention program targets 4 key behaviors (physical activity, fruit and vegetable consumption, sugary beverages, fried foods) aimed at reducing obesity risks in mothers and their children. Participants will also be provided opportunities to meet in groups with other participating mothers/infants to enhance social networks that support healthy eating and physical activity.
Standard HVP Curriculum: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
Obesity Prevention: Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
|
|---|---|---|---|---|
|
Social circumstances
Breach of Confidentiality
|
5.7%
2/35 • Number of events 2 • 4 years
Adverse event information was systematically collected and reported to IRB.
|
0.00%
0/42 • 4 years
Adverse event information was systematically collected and reported to IRB.
|
5.7%
2/35 • Number of events 2 • 4 years
Adverse event information was systematically collected and reported to IRB.
|
0.00%
0/42 • 4 years
Adverse event information was systematically collected and reported to IRB.
|
|
Social circumstances
Data Deletion
|
0.00%
0/35 • 4 years
Adverse event information was systematically collected and reported to IRB.
|
2.4%
1/42 • Number of events 1 • 4 years
Adverse event information was systematically collected and reported to IRB.
|
0.00%
0/35 • 4 years
Adverse event information was systematically collected and reported to IRB.
|
2.4%
1/42 • Number of events 1 • 4 years
Adverse event information was systematically collected and reported to IRB.
|
Additional Information
Kayla De La Haye, PhD, Research Scientist
USC Center for Economic and Social Research
Phone: 323-442-8228
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place