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

NCT05885581 | Completed

• 1 other identifier: UCRiverside
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Habit

Outcome Measures

Primary Outcomes (6)

• 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).

  0 months (infant birth) to one year

• 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.

  0 months (infant birth) to one year

• 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)

  0 months (infant birth) to one year

• 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)

  0 months (infant birth) to one year

• 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).

  0 months (infant birth) to one year

• 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.

  0 months (infant birth) to one year

Study Arms (2)

Group A

EXPERIMENTAL

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.

Other: Arm A Grow Well

Group B:

ACTIVE COMPARATOR

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).

Other: Arm B Healthy Steps

Interventions

Arm A Grow Well OTHER

1. the preliminary efficacy of the adapted intervention on mothers' and caregivers' infant feeding knowledge, use of recommended feeding practices, and infant anthropometric measurement outcomes. 2. the feasibility of implementing the intervention and its acceptability among mothers and caregivers. 3. the feasibility of collecting infant anthropometric data.

Also known as: Intervention

Group A

Arm B Healthy Steps OTHER

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).

Also known as: Control Group

Group B:

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as Latina Mothers with infant who identified as caregivers.
• 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.

You may not qualify if:

• Individual not willing to sign informed consent.
• Unable to speak English, Spanish or Perepecha.

Sponsors & Collaborators

• University of California, Riverside: lead

Study Sites (1)

UC Riverside

Riverside, California, 92521, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Methods; Control Groups

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: June 2, 2023
• Study Start: April 5, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)