Trial Outcomes & Findings for Healthy Homes, Healthy Habits (NCT NCT03433456)
NCT ID: NCT03433456
Last Updated: 2024-10-29
Results Overview
Body weight (kg) at baseline and follow-up assessments.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
296 participants
Primary outcome timeframe
Baseline, 6 months, 12 months
Results posted on
2024-10-29
Participant Flow
Participant milestones
| Measure |
Home Visitation + HABITS Program
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
138
|
|
Overall Study
Caregivers Started
|
79
|
69
|
|
Overall Study
Children Started
|
79
|
69
|
|
Overall Study
Caregivers Completed
|
71
|
63
|
|
Overall Study
Children Completed
|
71
|
63
|
|
Overall Study
COMPLETED
|
142
|
126
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
Reasons for withdrawal
| Measure |
Home Visitation + HABITS Program
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
11
|
|
Overall Study
Pt in ICU and unable to complete follow-up visit
|
1
|
0
|
Baseline Characteristics
Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
Baseline characteristics by cohort
| Measure |
Home Visitation + HABITS Program
n=158 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=138 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Caregivers · <=18 years
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Age, Categorical
Caregivers · Between 18 and 65 years
|
79 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
68 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
147 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Age, Categorical
Caregivers · >=65 years
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
1 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
1 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Age, Categorical
Children · <=18 years
|
79 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
69 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
148 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Age, Categorical
Children · Between 18 and 65 years
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Age, Categorical
Children · >=65 years
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Age, Continuous
Caregivers
|
31.52 Years
STANDARD_DEVIATION 6.83 • n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
32.52 Years
STANDARD_DEVIATION 9.66 • n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
31.98 Years
STANDARD_DEVIATION 8.26 • n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Age, Continuous
Children
|
2.71 Years
STANDARD_DEVIATION 1.24 • n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
2.59 Years
STANDARD_DEVIATION 1.22 • n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
2.66 Years
STANDARD_DEVIATION 1.22 • n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Sex: Female, Male
Caregivers · Female
|
78 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
69 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
147 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Sex: Female, Male
Caregivers · Male
|
1 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
1 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Sex: Female, Male
Children · Female
|
40 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
34 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
74 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Sex: Female, Male
Children · Male
|
39 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
35 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
74 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
6 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
3 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
9 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
73 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
66 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
139 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Ethnicity (NIH/OMB)
Children · Hispanic or Latino
|
6 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
2 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
8 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Ethnicity (NIH/OMB)
Children · Not Hispanic or Latino
|
73 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
67 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
140 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Ethnicity (NIH/OMB)
Children · Unknown or Not Reported
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Caregivers · Asian
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
60 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
53 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
113 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Caregivers · White
|
15 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
11 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
26 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
1 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
4 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
5 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
3 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
1 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
4 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Children · American Indian or Alaska Native
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Children · Asian
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Children · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Children · Black or African American
|
61 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
55 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
116 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Children · White
|
14 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
8 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
22 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Children · More than one race
|
2 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
6 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
8 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
|
Race (NIH/OMB)
Children · Unknown or Not Reported
|
2 Participants
n=79 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
0 Participants
n=69 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
2 Participants
n=148 Participants • Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
Body weight (kg) at baseline and follow-up assessments.
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=79 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=69 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Weight of Mothers
Baseline
|
88.65 Kilograms
Standard Deviation 26.04
|
97.43 Kilograms
Standard Deviation 31.29
|
|
Weight of Mothers
6-months
|
85.96 Kilograms
Standard Deviation 27.01
|
96.52 Kilograms
Standard Deviation 28.97
|
|
Weight of Mothers
12-months
|
85.94 Kilograms
Standard Deviation 23.78
|
98.75 Kilograms
Standard Deviation 30.77
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
Body weight (kg) at baseline and follow-up assessments..
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=79 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=69 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Weight of Children
Baseline
|
13.88 Kilograms
Standard Deviation 3.80
|
14.23 Kilograms
Standard Deviation 5.10
|
|
Weight of Children
6-months
|
15.40 Kilograms
Standard Deviation 3.76
|
15.94 Kilograms
Standard Deviation 5.21
|
|
Weight of Children
12-months
|
16.83 Kilograms
Standard Deviation 3.95
|
17.58 Kilograms
Standard Deviation 5.80
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
Habit strength for caregivers will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors on a scale from 1-5 with scores of 5 indicating higher caregiver habit strength for the target behavior.
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=79 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=69 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Habit Strength of Targeted Behaviors
Baseline- Fruit
|
3.58 Score on a scale
Standard Deviation 0.96
|
3.67 Score on a scale
Standard Deviation 0.91
|
|
Habit Strength of Targeted Behaviors
6-month- Fruit
|
3.86 Score on a scale
Standard Deviation 0.81
|
3.95 Score on a scale
Standard Deviation 0.71
|
|
Habit Strength of Targeted Behaviors
12-month- Fruit
|
3.91 Score on a scale
Standard Deviation 0.96
|
4.26 Score on a scale
Standard Deviation 0.80
|
|
Habit Strength of Targeted Behaviors
Baseline-Vegetables
|
3.72 Score on a scale
Standard Deviation 1.00
|
3.79 Score on a scale
Standard Deviation 0.84
|
|
Habit Strength of Targeted Behaviors
6-month-Vegetables
|
3.91 Score on a scale
Standard Deviation 0.82
|
4.07 Score on a scale
Standard Deviation 0.73
|
|
Habit Strength of Targeted Behaviors
12-month-Vegetables
|
4.02 Score on a scale
Standard Deviation 1.01
|
4.18 Score on a scale
Standard Deviation 0.84
|
|
Habit Strength of Targeted Behaviors
Baseline-Fried Food
|
3.30 Score on a scale
Standard Deviation 1.09
|
2.99 Score on a scale
Standard Deviation 1.01
|
|
Habit Strength of Targeted Behaviors
6-month-Fried Food
|
2.95 Score on a scale
Standard Deviation 1.09
|
2.89 Score on a scale
Standard Deviation 1.10
|
|
Habit Strength of Targeted Behaviors
12-month-Fried Food
|
2.96 Score on a scale
Standard Deviation 1.07
|
3.13 Score on a scale
Standard Deviation 1.09
|
|
Habit Strength of Targeted Behaviors
Baseline-SSB
|
3.41 Score on a scale
Standard Deviation 1.14
|
3.13 Score on a scale
Standard Deviation 1.18
|
|
Habit Strength of Targeted Behaviors
6-month-SSB
|
2.80 Score on a scale
Standard Deviation 1.13
|
2.98 Score on a scale
Standard Deviation 1.13
|
|
Habit Strength of Targeted Behaviors
12-month-SSB
|
3.19 Score on a scale
Standard Deviation 1.22
|
3.27 Score on a scale
Standard Deviation 1.20
|
|
Habit Strength of Targeted Behaviors
Baseline-Activity
|
4.09 Score on a scale
Standard Deviation 0.83
|
3.99 Score on a scale
Standard Deviation 0.78
|
|
Habit Strength of Targeted Behaviors
6-month-Activity
|
4.12 Score on a scale
Standard Deviation 0.73
|
4.08 Score on a scale
Standard Deviation 0.61
|
|
Habit Strength of Targeted Behaviors
12-month-Activity
|
4.13 Score on a scale
Standard Deviation 0.78
|
4.29 Score on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
Household environment assessing the number of different food items available in the home of the caregiver will be assessed using a modified Home Food Assessment (HFA) relating to the 4 food-related target behaviors (fruits, vegetables, sugary beverages, and fried foods). Higher values indicate more different food items in that category (fruits, vegetables, sugary beverages, and fried foods) are available within the home.
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=79 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=69 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Household Environment Assessing the Number of Different Food Items Available
Baseline-Fruit Availability
|
5.01 Available food items
Standard Deviation 3.14
|
5.64 Available food items
Standard Deviation 3.75
|
|
Household Environment Assessing the Number of Different Food Items Available
6-month-Fruit Availability
|
6.00 Available food items
Standard Deviation 3.89
|
5.58 Available food items
Standard Deviation 3.40
|
|
Household Environment Assessing the Number of Different Food Items Available
12-month-Fruit Availability
|
5.28 Available food items
Standard Deviation 3.11
|
5.66 Available food items
Standard Deviation 2.72
|
|
Household Environment Assessing the Number of Different Food Items Available
Baseline-Vegetable Availability
|
7.46 Available food items
Standard Deviation 3.66
|
7.29 Available food items
Standard Deviation 3.65
|
|
Household Environment Assessing the Number of Different Food Items Available
6-month-Vegetable Availability
|
6.69 Available food items
Standard Deviation 4.01
|
7.89 Available food items
Standard Deviation 4.56
|
|
Household Environment Assessing the Number of Different Food Items Available
12-month-Vegetable Availability
|
7.14 Available food items
Standard Deviation 3.83
|
7.34 Available food items
Standard Deviation 3.37
|
|
Household Environment Assessing the Number of Different Food Items Available
Baseline-Fried Food
|
3.61 Available food items
Standard Deviation 3.05
|
3.30 Available food items
Standard Deviation 2.41
|
|
Household Environment Assessing the Number of Different Food Items Available
6-month-Fried Food
|
3.72 Available food items
Standard Deviation 2.65
|
3.71 Available food items
Standard Deviation 2.15
|
|
Household Environment Assessing the Number of Different Food Items Available
12-month-Fried Food
|
4.08 Available food items
Standard Deviation 2.68
|
3.71 Available food items
Standard Deviation 2.36
|
|
Household Environment Assessing the Number of Different Food Items Available
Baseline-SSB
|
4.44 Available food items
Standard Deviation 2.89
|
3.84 Available food items
Standard Deviation 2.27
|
|
Household Environment Assessing the Number of Different Food Items Available
6-month-SSB
|
4.26 Available food items
Standard Deviation 2.66
|
4.09 Available food items
Standard Deviation 2.37
|
|
Household Environment Assessing the Number of Different Food Items Available
12-month-SSB
|
3.96 Available food items
Standard Deviation 2.43
|
3.68 Available food items
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
Household environment assessing the number of different activity-promoting items available in the home of the caregiver will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form. Higher values indicate more availability of different activity-promoting items in the home.
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=79 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=69 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Household Environment Assessing the Number of Different Activity-promoting Items Available
Baseline
|
3.96 Available activity items
Standard Deviation 1.77
|
3.81 Available activity items
Standard Deviation 1.58
|
|
Household Environment Assessing the Number of Different Activity-promoting Items Available
6-month
|
4.59 Available activity items
Standard Deviation 2.11
|
4.40 Available activity items
Standard Deviation 2.15
|
|
Household Environment Assessing the Number of Different Activity-promoting Items Available
12-month
|
4.30 Available activity items
Standard Deviation 1.62
|
4.74 Available activity items
Standard Deviation 2.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
Assessed using modified food and activity frequency measure from the National Health and Nutrition Examination Survey (NHANES), amended to measure target habit behaviors of feeding and activity. Scored on a scale from 0-6 with higher values indicated more frequent consumption of that food or engagement in that behavior.
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=79 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=69 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Maternal Eating Practices
Baseline-Fruit
|
2.67 Score on a scale
Standard Deviation 1.73
|
2.33 Score on a scale
Standard Deviation 1.36
|
|
Maternal Eating Practices
6-month-Fruit
|
3.11 Score on a scale
Standard Deviation 1.68
|
2.57 Score on a scale
Standard Deviation 1.38
|
|
Maternal Eating Practices
12-month-Fruit
|
2.94 Score on a scale
Standard Deviation 1.76
|
2.94 Score on a scale
Standard Deviation 1.61
|
|
Maternal Eating Practices
Baseline-Vegetable
|
2.99 Score on a scale
Standard Deviation 1.42
|
2.49 Score on a scale
Standard Deviation 1.35
|
|
Maternal Eating Practices
6-month-Vegetable
|
2.61 Score on a scale
Standard Deviation 1.42
|
2.66 Score on a scale
Standard Deviation 1.25
|
|
Maternal Eating Practices
12-month-Vegetable
|
2.73 Score on a scale
Standard Deviation 1.49
|
2.84 Score on a scale
Standard Deviation 1.43
|
|
Maternal Eating Practices
Baseline-Fried Food
|
1.96 Score on a scale
Standard Deviation 1.46
|
1.23 Score on a scale
Standard Deviation 0.97
|
|
Maternal Eating Practices
6-month-Fried Food
|
1.65 Score on a scale
Standard Deviation 1.29
|
1.37 Score on a scale
Standard Deviation 1.14
|
|
Maternal Eating Practices
12-month-Fried Food
|
1.38 Score on a scale
Standard Deviation 1.09
|
1.35 Score on a scale
Standard Deviation 1.17
|
|
Maternal Eating Practices
Baseline-Soda
|
2.35 Score on a scale
Standard Deviation 2.04
|
1.72 Score on a scale
Standard Deviation 1.89
|
|
Maternal Eating Practices
6-month-Soda
|
1.52 Score on a scale
Standard Deviation 1.44
|
1.48 Score on a scale
Standard Deviation 1.57
|
|
Maternal Eating Practices
12-month-Soda
|
1.66 Score on a scale
Standard Deviation 1.71
|
1.77 Score on a scale
Standard Deviation 1.88
|
|
Maternal Eating Practices
Baseline-Walk
|
4.30 Score on a scale
Standard Deviation 1.84
|
4.16 Score on a scale
Standard Deviation 1.94
|
|
Maternal Eating Practices
6-month-Walk
|
5.25 Score on a scale
Standard Deviation 1.52
|
4.78 Score on a scale
Standard Deviation 1.75
|
|
Maternal Eating Practices
12-month-Walk
|
5.14 Score on a scale
Standard Deviation 1.53
|
4.95 Score on a scale
Standard Deviation 1.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
Assessed using modified food and activity frequency measure from NHANES, amended to measure target habit behaviors of feeding and activity. Scored from 0-7 with higher values indicated more frequent consumption of food or engagement in the behavior.
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=79 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=69 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Maternal Feeding Practices
Baseline-Fruit
|
4.19 Score on a scale
Standard Deviation 1.96
|
4.14 Score on a scale
Standard Deviation 1.88
|
|
Maternal Feeding Practices
6-month-Fruit
|
4.46 Score on a scale
Standard Deviation 1.73
|
4.54 Score on a scale
Standard Deviation 1.45
|
|
Maternal Feeding Practices
12-month-Fruit
|
4.27 Score on a scale
Standard Deviation 1.65
|
4.37 Score on a scale
Standard Deviation 1.54
|
|
Maternal Feeding Practices
Baseline-Vegetable
|
4.03 Score on a scale
Standard Deviation 1.87
|
3.70 Score on a scale
Standard Deviation 1.74
|
|
Maternal Feeding Practices
6-month-Vegetable
|
3.81 Score on a scale
Standard Deviation 1.69
|
4.02 Score on a scale
Standard Deviation 1.52
|
|
Maternal Feeding Practices
12-month-Vegetable
|
3.86 Score on a scale
Standard Deviation 1.55
|
3.77 Score on a scale
Standard Deviation 1.62
|
|
Maternal Feeding Practices
Baseline-Fried Food
|
2.63 Score on a scale
Standard Deviation 1.70
|
2.13 Score on a scale
Standard Deviation 1.37
|
|
Maternal Feeding Practices
6-month-Fried Food
|
2.37 Score on a scale
Standard Deviation 1.14
|
2.29 Score on a scale
Standard Deviation 1.27
|
|
Maternal Feeding Practices
12-month-Fried Food
|
2.28 Score on a scale
Standard Deviation 1.24
|
2.11 Score on a scale
Standard Deviation 0.70
|
|
Maternal Feeding Practices
Baseline- Soda
|
1.73 Score on a scale
Standard Deviation 1.64
|
1.46 Score on a scale
Standard Deviation 1.28
|
|
Maternal Feeding Practices
6-month-Soda
|
1.72 Score on a scale
Standard Deviation 1.35
|
1.68 Score on a scale
Standard Deviation 1.32
|
|
Maternal Feeding Practices
12-month-Soda
|
1.72 Score on a scale
Standard Deviation 1.22
|
1.85 Score on a scale
Standard Deviation 1.34
|
|
Maternal Feeding Practices
Baseline-Activity
|
5.43 Score on a scale
Standard Deviation 1.89
|
5.22 Score on a scale
Standard Deviation 2.15
|
|
Maternal Feeding Practices
6-month-Activity
|
6.46 Score on a scale
Standard Deviation 1.18
|
6.09 Score on a scale
Standard Deviation 1.45
|
|
Maternal Feeding Practices
12-month-Activity
|
6.04 Score on a scale
Standard Deviation 1.61
|
5.92 Score on a scale
Standard Deviation 1.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
The Personal Health Questionnaire Depression Scale (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered to caregivers. PHQ-8 scores range from 0-24, higher scores indicate higher caregiver depressive symptoms.
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=79 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=69 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)
Baseline
|
4.59 Score on a scale
Standard Deviation 4.19
|
4.42 Score on a scale
Standard Deviation 4.39
|
|
Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)
6-months
|
3.48 Score on a scale
Standard Deviation 3.64
|
3.08 Score on a scale
Standard Deviation 3.56
|
|
Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)
12-months
|
3.64 Score on a scale
Standard Deviation 3.56
|
3.03 Score on a scale
Standard Deviation 3.70
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months, 12 monthsPopulation: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected.
Outcome measures
| Measure |
Home Visitation + HABITS Program
n=71 Participants
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program
n=65 Participants
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|
|
Number of Caregivers With Changes to Their Medical History
12-months · No change to medical history in last 6-months
|
68 Participants
|
60 Participants
|
|
Number of Caregivers With Changes to Their Medical History
6-months · Had a change to medical history in last 6-months
|
2 Participants
|
4 Participants
|
|
Number of Caregivers With Changes to Their Medical History
6-months · No change to medical history in last 6-months
|
51 Participants
|
61 Participants
|
|
Number of Caregivers With Changes to Their Medical History
12-months · Had a change to medical history in last 6-months
|
3 Participants
|
2 Participants
|
Adverse Events
Home Visitation + HABITS Program: Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Visitation + HABITS Program: Children
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Home Visitation Program: Caregivers
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Home Visitation Program: Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home Visitation + HABITS Program: Caregivers
n=79 participants at risk
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Home Visitation + HABITS Program: Children
n=79 participants at risk
The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.
Home visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program: Caregivers
n=69 participants at risk
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
Standard Home Visitation Program: Children
n=69 participants at risk
Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.
Standard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
|
|---|---|---|---|---|
|
Infections and infestations
Hospitalization
|
0.00%
0/79 • 1 year
|
1.3%
1/79 • Number of events 1 • 1 year
|
1.4%
1/69 • Number of events 1 • 1 year
|
0.00%
0/69 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place