Clinical trial NCT05885581: "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
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Efficacy of the adapted intervention on mothers' and caregivers' infant.
timeFrame: 0 months (infant birth) to one year
measure: Data Collection-Infant Feeding Practices
timeFrame: 0 months (infant birth) to one year
measure: Data collection-anthropometric data
timeFrame: 0 months (infant birth) to one year
measure: Data collection-anthropometric data
timeFrame: 0 months (infant birth) to one year
measure: Data collection-anthropometric data
timeFrame: 0 months (infant birth) to one year
measure: Data collection-sociodemographic questions
timeFrame: 0 months (infant birth) to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: UC Riverside
state: California
Study officials:
References: