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Clinical Trials/NCT05424471
NCT05424471CompletedNot Applicable

Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months, Long-term Follow-up

Johns Hopkins Bloomberg School of Public Health2 sites in 1 country110 target enrollmentStarted: May 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
110
Locations
2
Primary Endpoint
Group differences in sugar sweetened beverage (SSB) consumption & water intake.

Study Overview

Brief Summary

This study extends follow up on of Native American (NA) mothers and their children (now age 3-5 years) enrolled in the 1:1 randomized controlled trial of the Family Spirit Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1). The investigators will examine whether positive FSN impacts on sugar sweetened beverage (SSB) consumption and healthy growth in the first year of life were sustained. The investigators will also examine the effects of the emergency COVID-19 water solutions on water insecurity, early childhood SSB consumption, and growth, and explore how COVID-19 affected child feeding patterns and weight status either through changes in maternal mental health or household food access.

Detailed Description

Primary Aims

Aim 1. Determine the longer-term effectiveness of the brief FSN intervention on reducing SSB consumption, increasing water intake, and promoting healthy growth status up to 5 years of age.

Aim 2. Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency water response efforts, on water insecurity, children's water intake and SSB consumption with or without previous FSN intervention. Positive findings would provide leverage to promote water solutions and water equity.

Secondary Aims

Secondary Aim 1. Determine whether providing a booster lesson at 4 years of age targeting age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake impacts SSB consumption and water intake between 4 and 4.5 years of age and child growth between 4 and 5 years of age.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Mother/child dyads who enrolled, participated in/completed the initial PECO 1 study (followed mother/infant dyads through 12 months of age).
  • Willingness to fully participate.

Exclusion Criteria

  • Inability to participate in full intervention or evaluation (e.g., planned move, etc.)

Outcomes

Primary Outcomes

Group differences in sugar sweetened beverage (SSB) consumption & water intake.

Time Frame: 3 months to 5 years of age

Mothers were asked about SSB initiation and frequency among infants between 3 months and 12 months of age in the Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months study using an an adapted version of the Pre-School-Aged Beverage Intake Questionnaire (BEVQ-15). We will continue to use the age appropriate Pre-School-Aged BEVQ-15 to assess child's SSB consumption and water intake between 4 and 5 years of age. This data will be examined for between group differences in SSB consumption and water intake through 5 years of age.

Examine whether point-of-use (POU) water filters impact water security, and/or moderate intervention impact on water intake and SSB consumption.

Time Frame: 3 to 5 years of age

Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency water response efforts, on water insecurity. Examine study group differences in water intake and SSB consumption with and without POU water filters.

Group differences in children's mean BMI z-scores over time as assessed through child weight and length/height measurements through 5 years of age.

Time Frame: Birth to 5 years of age

Child weight (to the nearest ounce) and recumbent length/height (to the nearest 1/8 inch) will be extracted through medical chart review. Measurements will be taken by healthcare providers. Measurements will be used to calculate BMI z-scores using age- and sex-specific World Health Organization (WHO) Child Growth Standards.

Secondary Outcomes

  • Between study group differences, post booster lesson, in age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake.(Up to 5 years of age)
  • Within study group comparison of pre-/during- COVID-19 child feeding practices, snack routines, SSB consumption and water intake and examination of associations with maternal depression and anxiety, and changes in food access.(5 years postpartum)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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