search
Back to results

"Grow Well: Addressing Childhood Obesity in Low-income Families"

Primary Purpose

Diet Habit

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm A Grow Well
Arm B Healthy Steps
Sponsored by
University of California, Riverside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diet Habit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Identify as Latina Mothers with infant who identified as caregivers. 18 years or older. Speak English, Spanish or Purépecha. Mother (biological, adoptive, foster) of an infant ages 4 months or younger, who had a normal birth weight (greater than or equal to 5. lbs., 8 oz.) Live in Inland Southern California. Income eligible (mothers or their children) for government programs such as WIC, Early Head Start, MediCal, CalFresh and similar programs. Willing to have a community health worker enter your home to provide 30-45 minute in person sessions once per month over 6 months. Have another caregiver 18 years or older who participates in at least 3 hours of care per week and agrees to participate in the home sessions. Exclusion Criteria: Individual not willing to sign informed consent. Unable to speak English, Spanish or Perepecha.

Sites / Locations

  • UC RiversideRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B:

Arm Description

Grow Well and will receive the adapted Healthy Beginnings Curriculum (n= 15 mother-infant-caregiver triad) determine the feasibility, acceptability, and preliminary efficacy of the adapted intervention. The intervention will be on mothers' and caregivers' infant feeding knowledge, use of recommended feeding practices, and infant anthropometric measurement outcomes.

Group B will receive the Healthy Steps curriculum or treatment as usual as this is the curriculum commonly shared during well baby visits (n= 15 mother-infant-caregiver triad).

Outcomes

Primary Outcome Measures

Efficacy of the adapted intervention on mothers' and caregivers' infant.
It will include an intervention and control group and will be carried out over 6 months or 24 weeks and will involve 30 mother-infant-caregiver triads. Pretest and posttest surveys will be collected at baseline (week 1), and at six months follow up (week 24).
Data Collection-Infant Feeding Practices
The survey will collect data on infant feeding practices using the validated Infant Feeding Scale Questionnaire (Thompson et al., 2009). It questionnaire is designed to assess maternal attitude towards infant feeding methods and to predict breastfeeding intention and exclusivity. The scale is composed of 17 items with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).The measurements of unit will be in fluid ounces.
Data collection-anthropometric data
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant body fat composition using fat calipers; Skinfolds (mm) Triceps (mm); Subscapular (mm); Liver (mm); Flank(mm); Thigh (mm)
Data collection-anthropometric data
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant weight using Body measurements: Child Weight (kg)
Data collection-anthropometric data
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant length using an infant measuring device that infants lay on, and body fat composition using fat calipers. Length (cm).
Data collection-sociodemographic questions
The study team members will collect data Socio-demographic variables include, for example, age, sex, education, migration background and ethnicity, religious affiliation, marital status, household, employment, and income.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
June 1, 2023
Sponsor
University of California, Riverside
search

1. Study Identification

Unique Protocol Identification Number
NCT05885581
Brief Title
"Grow Well: Addressing Childhood Obesity in Low-income Families"
Official Title
Grow Well/Crecer Bien: Addressing Childhood Obesity in Low-income Families
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Riverside

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This research uses community based participatory research (CBPR) to engage low-income Latinx families in research to pilot test an adapted nutrition education program compared to an existing nutrition education program. The goal of the research is to provide nutrition education on healthy infant feeding to reduce risk for early childhood obesity. The prevalence of obesity in early life remains unacceptably high, especially among low-income children, most are ethnic minorities. Marked ethnic disparities are evident by two years of age, which suggests that existing interventions are not adequate. This project, which focuses on an-at-risk child population, has great potential to address our nation's growing crisis of childhood obesity, which can dramatically improve the health of millions of low-income children, their families, and their future children.
Detailed Description
This research will implement and evaluate an existing healthy infant feeding intervention, Healthy Beginnings, which was developed for English-speaking low-income mothers in Australia and delivered by public health nurses via in-home visits. The investigator will test the efficacy of an adapted version of this intervention in comparison to the original intervention. Aim 1. Pilot test an adapted nutrition education program of, compared to the original program curriculum. ● Using a pilot randomized control trial with 30 mother-infant-caregiver triad (15 intervention, 15 control) determine the feasibility, acceptability, and preliminary efficacy of the adapted intervention compared to the original intervention. The investigator hypothesize that the adapted intervention will be feasible, acceptable to study participants, and efficacious in addressing feeding styles and practices and caregivers' role in infant feeding. The investigator anticipate that the intervention will be feasible to deliver and acceptable to mothers' participants and caregivers' participants, and that the mother's participants-infant-caregiver triads randomized to intervention with the adapted Healthy Beginnings curriculum compared to the treatment as usual control group will demonstrate greater improvements in outcomes (i.e., infant feeding knowledge and use of recommended feeding practices) after 6 months compared to the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Habit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The goal of the research is to provide nutrition education on healthy infant feeding to reduce risk for early childhood obesity. The prevalence of obesity in early life remains unacceptably high, especially among low-income children, most are ethnic minorities. Marked ethnic disparities are evident by two years of age, which suggests that existing interventions are not adequate. Early prevention is critical, especially for low-income children. This project, which focuses on an-at-risk child population, has great potential to address our nation's growing crisis of childhood obesity, which can dramatically improve the health of millions of low-income children, their families, and their future children.
Masking
Care Provider
Masking Description
Randomization will occur once base-line data is collected. Comparisons will be made between the intervention and control groups during the first 6 months of the intervention. The focus is on Latinx Spanish-speaking families; however, all our material is in English and Spanish to accommodate language preferences. Additionally, if a mother or caregiver prefers Purépecha, a language commonly spoken in the region, a Purépecha-speaking team member can translate orally from Spanish to Purépecha as this is an oral and not written language.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Grow Well and will receive the adapted Healthy Beginnings Curriculum (n= 15 mother-infant-caregiver triad) determine the feasibility, acceptability, and preliminary efficacy of the adapted intervention. The intervention will be on mothers' and caregivers' infant feeding knowledge, use of recommended feeding practices, and infant anthropometric measurement outcomes.
Arm Title
Group B:
Arm Type
Active Comparator
Arm Description
Group B will receive the Healthy Steps curriculum or treatment as usual as this is the curriculum commonly shared during well baby visits (n= 15 mother-infant-caregiver triad).
Intervention Type
Other
Intervention Name(s)
Arm A Grow Well
Other Intervention Name(s)
Intervention
Intervention Description
the preliminary efficacy of the adapted intervention on mothers' and caregivers' infant feeding knowledge, use of recommended feeding practices, and infant anthropometric measurement outcomes. the feasibility of implementing the intervention and its acceptability among mothers and caregivers. the feasibility of collecting infant anthropometric data.
Intervention Type
Other
Intervention Name(s)
Arm B Healthy Steps
Other Intervention Name(s)
Control Group
Intervention Description
Group B: Healthy Steps and will receive the Healthy Steps curriculum or treatment as usual as this is the curriculum commonly shared during well baby visits (n= 15 mother-infant-caregiver triad).
Primary Outcome Measure Information:
Title
Efficacy of the adapted intervention on mothers' and caregivers' infant.
Description
It will include an intervention and control group and will be carried out over 6 months or 24 weeks and will involve 30 mother-infant-caregiver triads. Pretest and posttest surveys will be collected at baseline (week 1), and at six months follow up (week 24).
Time Frame
0 months (infant birth) to one year
Title
Data Collection-Infant Feeding Practices
Description
The survey will collect data on infant feeding practices using the validated Infant Feeding Scale Questionnaire (Thompson et al., 2009). It questionnaire is designed to assess maternal attitude towards infant feeding methods and to predict breastfeeding intention and exclusivity. The scale is composed of 17 items with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).The measurements of unit will be in fluid ounces.
Time Frame
0 months (infant birth) to one year
Title
Data collection-anthropometric data
Description
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant body fat composition using fat calipers; Skinfolds (mm) Triceps (mm); Subscapular (mm); Liver (mm); Flank(mm); Thigh (mm)
Time Frame
0 months (infant birth) to one year
Title
Data collection-anthropometric data
Description
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant weight using Body measurements: Child Weight (kg)
Time Frame
0 months (infant birth) to one year
Title
Data collection-anthropometric data
Description
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant length using an infant measuring device that infants lay on, and body fat composition using fat calipers. Length (cm).
Time Frame
0 months (infant birth) to one year
Title
Data collection-sociodemographic questions
Description
The study team members will collect data Socio-demographic variables include, for example, age, sex, education, migration background and ethnicity, religious affiliation, marital status, household, employment, and income.
Time Frame
0 months (infant birth) to one year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Identify as Latina Mothers with infant who identified as caregivers. 18 years or older. Speak English, Spanish or Purépecha. Mother (biological, adoptive, foster) of an infant ages 4 months or younger, who had a normal birth weight (greater than or equal to 5. lbs., 8 oz.) Live in Inland Southern California. Income eligible (mothers or their children) for government programs such as WIC, Early Head Start, MediCal, CalFresh and similar programs. Willing to have a community health worker enter your home to provide 30-45 minute in person sessions once per month over 6 months. Have another caregiver 18 years or older who participates in at least 3 hours of care per week and agrees to participate in the home sessions. Exclusion Criteria: Individual not willing to sign informed consent. Unable to speak English, Spanish or Perepecha.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Cheney, PhD
Phone
501-352-8526
Email
ann.cheney@medsch.ucr.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Herlinda Bergman
Phone
951-827-2657
Email
herlinda.bergman@medsch.ucr.edu
Facility Information:
Facility Name
UC Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Davis
Phone
951-827-5733
Email
christine.davis@medsch.ucr.edu
First Name & Middle Initial & Last Name & Degree
Ann Cheney, PhD
First Name & Middle Initial & Last Name & Degree
Maria Pozar

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

"Grow Well: Addressing Childhood Obesity in Low-income Families"

We'll reach out to this number within 24 hrs