Obesity, Obesity, Childhood, Obesity; Familial
Conditions
Keywords
obesity, low-income, health disparities, home visitation, prevention, childhood obesity, habit
Brief summary
The purpose of this study is to evaluate whether an intervention targeting healthy habit development reduces the risk and prevalence of obesity in low-income mothers and children. The study intends to evaluate whether the intervention, delivered in the context of home visitation services for low-income families, reduces weight gain and risk factors associated with parent and childhood obesity compared to those receiving standard home visitation services.
Detailed description
Participants will be 140 mothers (\>50% African American; 100% meet federal poverty level) and their children (n=140; 0-4yo at baseline) (total of N=140 mother-child dyads; i.e., 140 mothers + 140 children = 280 total participants) enrolled in our home visitation partner in central Alabama. Home visitors will be randomly assigned to deliver the home visitation curriculum with or without HABITS (an obesity prevention program targeting key eating and activity behaviors) as part of their monthly home visits for 12 months. Treatment sessions for standard of care or standard + HABITS arms will be facilitated by trained home visitors. If a mother or primary caregiver and her child are randomized to participate in the HABITS + Standard home visitation curriculum, they will receive \ 15 minutes of information, activities, and assistance regarding the development of key behaviors relating to obesity prevention, which will be imbedded within the existing home visitation curriculum. The HABITS program will address habit-formation of four behaviors relevant to mothers or primary caregivers and children: (1) limit fried foods; (2) limit sugar-sweetened beverages (SSB); (3) increase daily steps; (4) increase fruits and vegetables. Additionally, mothers or primary caregivers will also practice habit formation focused on self-monitoring of weight and the four behaviors previously mentioned. Skill training will focus on habit formation and home environment modification conducive to the four behaviors. Mothers or primary caregivers in the intervention group will be provided the HABITS + standard home visitation program for 12 months, while those in the control group will be provided the standard home visitation program during this time. 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.
Interventions
BEHAVIORALHome 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.
BEHAVIORALStandard 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Caregiver-child dyads will be randomized to either the intervention group (receiving home intervention + HABITS program) or the a control group to receive their standard of care (home intervention without HABITS)
Eligibility
Sex/Gender
ALL
Age
0 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
\*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate. Mothers or Primary Caregivers: * Age 18-75 years of age * Enrollment in First Teacher Home Visiting Program (First Teacher) through the Family Guidance Center of Alabama. * Mother or primary caregiver of 0-4 year old child * Generally Healthy Children: * 0-4 years of age at time of enrollment * Parent or primary caregiver enrolled in First Teacher
Exclusion criteria
Mothers or primary caregivers: * Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program. Children: * Child has a history of a feeding or eating disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight of Mothers | Baseline, 6 months, 12 months | Body weight (kg) at baseline and follow-up assessments. |
| Weight of Children | Baseline, 6 months, 12 months | Body weight (kg) at baseline and follow-up assessments.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Habit Strength of Targeted Behaviors | Baseline, 6 months, 12 months | 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. |
| Household Environment Assessing the Number of Different Food Items Available | Baseline, 6 months, 12 months | 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. |
| Household Environment Assessing the Number of Different Activity-promoting Items Available | Baseline, 6 months, 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8) | Baseline, 6 months, 12 months | 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. |
| Maternal Feeding Practices | Baseline, 6 months, 12 months | 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. |
| Number of Caregivers With Changes to Their Medical History | 6 months, 12 months | Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected. |
| Maternal Eating Practices | Baseline, 6 months, 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 158 |
| 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. | 138 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Home Visitation + HABITS Program | Total | Standard Home Visitation Program |
|---|---|---|---|
| Age, Categorical Caregivers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregivers >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Caregivers Between 18 and 65 years | 79 Participants | 147 Participants | 68 Participants |
| Age, Categorical Children <=18 years | 79 Participants | 148 Participants | 69 Participants |
| Age, Categorical Children >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Children Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Caregivers | 31.52 Years STANDARD_DEVIATION 6.83 | 31.98 Years STANDARD_DEVIATION 8.26 | 32.52 Years STANDARD_DEVIATION 9.66 |
| Age, Continuous Children | 2.71 Years STANDARD_DEVIATION 1.24 | 2.66 Years STANDARD_DEVIATION 1.22 | 2.59 Years STANDARD_DEVIATION 1.22 |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 6 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 73 Participants | 139 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Children Hispanic or Latino | 6 Participants | 8 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Children Not Hispanic or Latino | 73 Participants | 140 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Children Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 60 Participants | 113 Participants | 53 Participants |
| Race (NIH/OMB) Caregivers More than one race | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers White | 15 Participants | 26 Participants | 11 Participants |
| Race (NIH/OMB) Children American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Children Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Children Black or African American | 61 Participants | 116 Participants | 55 Participants |
| Race (NIH/OMB) Children More than one race | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Children Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Children Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Children White | 14 Participants | 22 Participants | 8 Participants |
| Sex: Female, Male Caregivers Female | 78 Participants | 147 Participants | 69 Participants |
| Sex: Female, Male Caregivers Male | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Children Female | 40 Participants | 74 Participants | 34 Participants |
| Sex: Female, Male Children Male | 39 Participants | 74 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 1 / 79 | 1 / 69 | 0 / 69 |
| other Total, other adverse events | 0 / 79 | 0 / 79 | 0 / 69 | 0 / 69 |
| serious Total, serious adverse events | 0 / 79 | 1 / 79 | 1 / 69 | 0 / 69 |
Outcome results
Primary
Weight of Children
Body weight (kg) at baseline and follow-up assessments..
Time frame: Baseline, 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Weight of Children | Baseline | 13.88 Kilograms | Standard Deviation 3.8 |
| Home Visitation + HABITS Program | Weight of Children | 6-months | 15.40 Kilograms | Standard Deviation 3.76 |
| Home Visitation + HABITS Program | Weight of Children | 12-months | 16.83 Kilograms | Standard Deviation 3.95 |
| Standard Home Visitation Program | Weight of Children | Baseline | 14.23 Kilograms | Standard Deviation 5.1 |
| Standard Home Visitation Program | Weight of Children | 6-months | 15.94 Kilograms | Standard Deviation 5.21 |
| Standard Home Visitation Program | Weight of Children | 12-months | 17.58 Kilograms | Standard Deviation 5.8 |
Primary
Weight of Mothers
Body weight (kg) at baseline and follow-up assessments.
Time frame: Baseline, 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Weight of Mothers | Baseline | 88.65 Kilograms | Standard Deviation 26.04 |
| Home Visitation + HABITS Program | Weight of Mothers | 6-months | 85.96 Kilograms | Standard Deviation 27.01 |
| Home Visitation + HABITS Program | Weight of Mothers | 12-months | 85.94 Kilograms | Standard Deviation 23.78 |
| Standard Home Visitation Program | Weight of Mothers | Baseline | 97.43 Kilograms | Standard Deviation 31.29 |
| Standard Home Visitation Program | Weight of Mothers | 6-months | 96.52 Kilograms | Standard Deviation 28.97 |
| Standard Home Visitation Program | Weight of Mothers | 12-months | 98.75 Kilograms | Standard Deviation 30.77 |
Secondary
Habit Strength of Targeted Behaviors
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.
Time frame: Baseline, 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 12-month-Fried Food | 2.96 Score on a scale | Standard Deviation 1.07 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | Baseline- Fruit | 3.58 Score on a scale | Standard Deviation 0.96 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 6-month- Fruit | 3.86 Score on a scale | Standard Deviation 0.81 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 12-month- Fruit | 3.91 Score on a scale | Standard Deviation 0.96 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | Baseline-Vegetables | 3.72 Score on a scale | Standard Deviation 1 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 6-month-Vegetables | 3.91 Score on a scale | Standard Deviation 0.82 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 12-month-Vegetables | 4.02 Score on a scale | Standard Deviation 1.01 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | Baseline-Fried Food | 3.30 Score on a scale | Standard Deviation 1.09 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 6-month-Fried Food | 2.95 Score on a scale | Standard Deviation 1.09 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | Baseline-SSB | 3.41 Score on a scale | Standard Deviation 1.14 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 6-month-SSB | 2.80 Score on a scale | Standard Deviation 1.13 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 12-month-SSB | 3.19 Score on a scale | Standard Deviation 1.22 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | Baseline-Activity | 4.09 Score on a scale | Standard Deviation 0.83 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 6-month-Activity | 4.12 Score on a scale | Standard Deviation 0.73 |
| Home Visitation + HABITS Program | Habit Strength of Targeted Behaviors | 12-month-Activity | 4.13 Score on a scale | Standard Deviation 0.78 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 12-month-SSB | 3.27 Score on a scale | Standard Deviation 1.2 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 6-month-Fried Food | 2.89 Score on a scale | Standard Deviation 1.1 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | Baseline- Fruit | 3.67 Score on a scale | Standard Deviation 0.91 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 12-month-Fried Food | 3.13 Score on a scale | Standard Deviation 1.09 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 6-month- Fruit | 3.95 Score on a scale | Standard Deviation 0.71 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 6-month-Activity | 4.08 Score on a scale | Standard Deviation 0.61 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 12-month- Fruit | 4.26 Score on a scale | Standard Deviation 0.8 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | Baseline-SSB | 3.13 Score on a scale | Standard Deviation 1.18 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | Baseline-Vegetables | 3.79 Score on a scale | Standard Deviation 0.84 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | Baseline-Activity | 3.99 Score on a scale | Standard Deviation 0.78 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 6-month-Vegetables | 4.07 Score on a scale | Standard Deviation 0.73 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 6-month-SSB | 2.98 Score on a scale | Standard Deviation 1.13 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 12-month-Vegetables | 4.18 Score on a scale | Standard Deviation 0.84 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | 12-month-Activity | 4.29 Score on a scale | Standard Deviation 0.56 |
| Standard Home Visitation Program | Habit Strength of Targeted Behaviors | Baseline-Fried Food | 2.99 Score on a scale | Standard Deviation 1.01 |
Secondary
Household Environment Assessing the Number of Different Activity-promoting Items Available
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.
Time frame: Baseline, 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Activity-promoting Items Available | Baseline | 3.96 Available activity items | Standard Deviation 1.77 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Activity-promoting Items Available | 6-month | 4.59 Available activity items | Standard Deviation 2.11 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Activity-promoting Items Available | 12-month | 4.30 Available activity items | Standard Deviation 1.62 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Activity-promoting Items Available | Baseline | 3.81 Available activity items | Standard Deviation 1.58 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Activity-promoting Items Available | 6-month | 4.40 Available activity items | Standard Deviation 2.15 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Activity-promoting Items Available | 12-month | 4.74 Available activity items | Standard Deviation 2.17 |
Secondary
Household Environment Assessing the Number of Different Food Items Available
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.
Time frame: Baseline, 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | Baseline-Fried Food | 3.61 Available food items | Standard Deviation 3.05 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | Baseline-Fruit Availability | 5.01 Available food items | Standard Deviation 3.14 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | 6-month-Fried Food | 3.72 Available food items | Standard Deviation 2.65 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | 6-month-Fruit Availability | 6.00 Available food items | Standard Deviation 3.89 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | 12-month-Fried Food | 4.08 Available food items | Standard Deviation 2.68 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | 6-month-Vegetable Availability | 6.69 Available food items | Standard Deviation 4.01 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | Baseline-SSB | 4.44 Available food items | Standard Deviation 2.89 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | Baseline-Vegetable Availability | 7.46 Available food items | Standard Deviation 3.66 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | 6-month-SSB | 4.26 Available food items | Standard Deviation 2.66 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | 12-month-Vegetable Availability | 7.14 Available food items | Standard Deviation 3.83 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | 12-month-SSB | 3.96 Available food items | Standard Deviation 2.43 |
| Home Visitation + HABITS Program | Household Environment Assessing the Number of Different Food Items Available | 12-month-Fruit Availability | 5.28 Available food items | Standard Deviation 3.11 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | 12-month-SSB | 3.68 Available food items | Standard Deviation 2.45 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | 6-month-Fruit Availability | 5.58 Available food items | Standard Deviation 3.4 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | 12-month-Fruit Availability | 5.66 Available food items | Standard Deviation 2.72 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | Baseline-Vegetable Availability | 7.29 Available food items | Standard Deviation 3.65 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | 6-month-Vegetable Availability | 7.89 Available food items | Standard Deviation 4.56 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | 12-month-Vegetable Availability | 7.34 Available food items | Standard Deviation 3.37 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | Baseline-Fried Food | 3.30 Available food items | Standard Deviation 2.41 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | 6-month-Fried Food | 3.71 Available food items | Standard Deviation 2.15 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | 12-month-Fried Food | 3.71 Available food items | Standard Deviation 2.36 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | Baseline-SSB | 3.84 Available food items | Standard Deviation 2.27 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | 6-month-SSB | 4.09 Available food items | Standard Deviation 2.37 |
| Standard Home Visitation Program | Household Environment Assessing the Number of Different Food Items Available | Baseline-Fruit Availability | 5.64 Available food items | Standard Deviation 3.75 |
Other Pre-specified
Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)
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.
Time frame: Baseline, 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8) | Baseline | 4.59 Score on a scale | Standard Deviation 4.19 |
| Home Visitation + HABITS Program | Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8) | 6-months | 3.48 Score on a scale | Standard Deviation 3.64 |
| Home Visitation + HABITS Program | Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8) | 12-months | 3.64 Score on a scale | Standard Deviation 3.56 |
| Standard Home Visitation Program | Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8) | Baseline | 4.42 Score on a scale | Standard Deviation 4.39 |
| Standard Home Visitation Program | Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8) | 6-months | 3.08 Score on a scale | Standard Deviation 3.56 |
| Standard Home Visitation Program | Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8) | 12-months | 3.03 Score on a scale | Standard Deviation 3.7 |
Other Pre-specified
Maternal Eating Practices
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.
Time frame: Baseline, 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Maternal Eating Practices | 12-month-Vegetable | 2.73 Score on a scale | Standard Deviation 1.49 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 12-month-Fried Food | 1.38 Score on a scale | Standard Deviation 1.09 |
| Home Visitation + HABITS Program | Maternal Eating Practices | Baseline-Vegetable | 2.99 Score on a scale | Standard Deviation 1.42 |
| Home Visitation + HABITS Program | Maternal Eating Practices | Baseline-Soda | 2.35 Score on a scale | Standard Deviation 2.04 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 6-month-Fruit | 3.11 Score on a scale | Standard Deviation 1.68 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 6-month-Soda | 1.52 Score on a scale | Standard Deviation 1.44 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 6-month-Vegetable | 2.61 Score on a scale | Standard Deviation 1.42 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 12-month-Soda | 1.66 Score on a scale | Standard Deviation 1.71 |
| Home Visitation + HABITS Program | Maternal Eating Practices | Baseline-Fruit | 2.67 Score on a scale | Standard Deviation 1.73 |
| Home Visitation + HABITS Program | Maternal Eating Practices | Baseline-Walk | 4.30 Score on a scale | Standard Deviation 1.84 |
| Home Visitation + HABITS Program | Maternal Eating Practices | Baseline-Fried Food | 1.96 Score on a scale | Standard Deviation 1.46 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 6-month-Walk | 5.25 Score on a scale | Standard Deviation 1.52 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 12-month-Fruit | 2.94 Score on a scale | Standard Deviation 1.76 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 12-month-Walk | 5.14 Score on a scale | Standard Deviation 1.53 |
| Home Visitation + HABITS Program | Maternal Eating Practices | 6-month-Fried Food | 1.65 Score on a scale | Standard Deviation 1.29 |
| Standard Home Visitation Program | Maternal Eating Practices | 12-month-Walk | 4.95 Score on a scale | Standard Deviation 1.61 |
| Standard Home Visitation Program | Maternal Eating Practices | Baseline-Fruit | 2.33 Score on a scale | Standard Deviation 1.36 |
| Standard Home Visitation Program | Maternal Eating Practices | 6-month-Fruit | 2.57 Score on a scale | Standard Deviation 1.38 |
| Standard Home Visitation Program | Maternal Eating Practices | 12-month-Fruit | 2.94 Score on a scale | Standard Deviation 1.61 |
| Standard Home Visitation Program | Maternal Eating Practices | Baseline-Vegetable | 2.49 Score on a scale | Standard Deviation 1.35 |
| Standard Home Visitation Program | Maternal Eating Practices | 12-month-Vegetable | 2.84 Score on a scale | Standard Deviation 1.43 |
| Standard Home Visitation Program | Maternal Eating Practices | Baseline-Fried Food | 1.23 Score on a scale | Standard Deviation 0.97 |
| Standard Home Visitation Program | Maternal Eating Practices | 6-month-Fried Food | 1.37 Score on a scale | Standard Deviation 1.14 |
| Standard Home Visitation Program | Maternal Eating Practices | 12-month-Fried Food | 1.35 Score on a scale | Standard Deviation 1.17 |
| Standard Home Visitation Program | Maternal Eating Practices | Baseline-Soda | 1.72 Score on a scale | Standard Deviation 1.89 |
| Standard Home Visitation Program | Maternal Eating Practices | 6-month-Soda | 1.48 Score on a scale | Standard Deviation 1.57 |
| Standard Home Visitation Program | Maternal Eating Practices | 12-month-Soda | 1.77 Score on a scale | Standard Deviation 1.88 |
| Standard Home Visitation Program | Maternal Eating Practices | Baseline-Walk | 4.16 Score on a scale | Standard Deviation 1.94 |
| Standard Home Visitation Program | Maternal Eating Practices | 6-month-Walk | 4.78 Score on a scale | Standard Deviation 1.75 |
| Standard Home Visitation Program | Maternal Eating Practices | 6-month-Vegetable | 2.66 Score on a scale | Standard Deviation 1.25 |
Other Pre-specified
Maternal Feeding Practices
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.
Time frame: Baseline, 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Maternal Feeding Practices | 12-month-Activity | 6.04 Score on a scale | Standard Deviation 1.61 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 6-month-Fruit | 4.46 Score on a scale | Standard Deviation 1.73 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 12-month-Fruit | 4.27 Score on a scale | Standard Deviation 1.65 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | Baseline-Vegetable | 4.03 Score on a scale | Standard Deviation 1.87 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 6-month-Vegetable | 3.81 Score on a scale | Standard Deviation 1.69 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 12-month-Vegetable | 3.86 Score on a scale | Standard Deviation 1.55 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | Baseline-Fried Food | 2.63 Score on a scale | Standard Deviation 1.7 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 6-month-Fried Food | 2.37 Score on a scale | Standard Deviation 1.14 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 12-month-Fried Food | 2.28 Score on a scale | Standard Deviation 1.24 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | Baseline- Soda | 1.73 Score on a scale | Standard Deviation 1.64 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 6-month-Soda | 1.72 Score on a scale | Standard Deviation 1.35 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 12-month-Soda | 1.72 Score on a scale | Standard Deviation 1.22 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | Baseline-Activity | 5.43 Score on a scale | Standard Deviation 1.89 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | 6-month-Activity | 6.46 Score on a scale | Standard Deviation 1.18 |
| Home Visitation + HABITS Program | Maternal Feeding Practices | Baseline-Fruit | 4.19 Score on a scale | Standard Deviation 1.96 |
| Standard Home Visitation Program | Maternal Feeding Practices | 6-month-Soda | 1.68 Score on a scale | Standard Deviation 1.32 |
| Standard Home Visitation Program | Maternal Feeding Practices | Baseline-Fruit | 4.14 Score on a scale | Standard Deviation 1.88 |
| Standard Home Visitation Program | Maternal Feeding Practices | 6-month-Fried Food | 2.29 Score on a scale | Standard Deviation 1.27 |
| Standard Home Visitation Program | Maternal Feeding Practices | 12-month-Activity | 5.92 Score on a scale | Standard Deviation 1.85 |
| Standard Home Visitation Program | Maternal Feeding Practices | 6-month-Fruit | 4.54 Score on a scale | Standard Deviation 1.45 |
| Standard Home Visitation Program | Maternal Feeding Practices | Baseline-Activity | 5.22 Score on a scale | Standard Deviation 2.15 |
| Standard Home Visitation Program | Maternal Feeding Practices | 12-month-Fruit | 4.37 Score on a scale | Standard Deviation 1.54 |
| Standard Home Visitation Program | Maternal Feeding Practices | 12-month-Fried Food | 2.11 Score on a scale | Standard Deviation 0.7 |
| Standard Home Visitation Program | Maternal Feeding Practices | Baseline-Vegetable | 3.70 Score on a scale | Standard Deviation 1.74 |
| Standard Home Visitation Program | Maternal Feeding Practices | 12-month-Soda | 1.85 Score on a scale | Standard Deviation 1.34 |
| Standard Home Visitation Program | Maternal Feeding Practices | 6-month-Vegetable | 4.02 Score on a scale | Standard Deviation 1.52 |
| Standard Home Visitation Program | Maternal Feeding Practices | Baseline- Soda | 1.46 Score on a scale | Standard Deviation 1.28 |
| Standard Home Visitation Program | Maternal Feeding Practices | 12-month-Vegetable | 3.77 Score on a scale | Standard Deviation 1.62 |
| Standard Home Visitation Program | Maternal Feeding Practices | 6-month-Activity | 6.09 Score on a scale | Standard Deviation 1.45 |
| Standard Home Visitation Program | Maternal Feeding Practices | Baseline-Fried Food | 2.13 Score on a scale | Standard Deviation 1.37 |
Other Pre-specified
Number of Caregivers With Changes to Their Medical History
Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected.
Time frame: 6 months, 12 months
Population: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Home Visitation + HABITS Program | Number of Caregivers With Changes to Their Medical History | 6-months | Had a change to medical history in last 6-months | 2 Participants |
| Home Visitation + HABITS Program | Number of Caregivers With Changes to Their Medical History | 6-months | No change to medical history in last 6-months | 51 Participants |
| Home Visitation + HABITS Program | Number of Caregivers With Changes to Their Medical History | 12-months | Had a change to medical history in last 6-months | 3 Participants |
| Home Visitation + HABITS Program | Number of Caregivers With Changes to Their Medical History | 12-months | No change to medical history in last 6-months | 68 Participants |
| Standard Home Visitation Program | Number of Caregivers With Changes to Their Medical History | 12-months | No change to medical history in last 6-months | 60 Participants |
| Standard Home Visitation Program | Number of Caregivers With Changes to Their Medical History | 6-months | Had a change to medical history in last 6-months | 4 Participants |
| Standard Home Visitation Program | Number of Caregivers With Changes to Their Medical History | 12-months | Had a change to medical history in last 6-months | 2 Participants |
| Standard Home Visitation Program | Number of Caregivers With Changes to Their Medical History | 6-months | No change to medical history in last 6-months | 61 Participants |