Preventing Early Childhood Obesity, Part 1: Long-term Follow-up

NCT05424471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-08-21

No results posted yet for this study

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.

Conditions

  • Obesity
  • Water; Lack of
  • Childhood Obesity
  • Feeding Behavior
  • Mother-Child Relations
  • Dietary Habits

Interventions

BEHAVIORAL

Family Spirit Nurture (FSN)

The FSN intervention lesson is taught to participants previously randomized into the FSN intervention group during the PECO 1 study. Intervention group participants receive 1 Family Spirit Nurture lesson taught by Family Health Coaches. Mothers will receive the 1 - 45 minute lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The lesson focuses on age-appropriate parental feeding practices, including snack routines, avoidance of SSBs and promotion of water consumption. The lesson is highly visual and interactive, and incorporates cultural teachings related to child feeding and nutrition that support aims. The Family Health Coaches also provide social support and will facilitate referrals to community resources.

OTHER

Control Group - Vehicle Safety

The control (vehicle safety) lesson is taught to participants previously randomized into the control group during the PECO 1 study. Control group participants receive 1 - 30 minute lesson with vehicle safety information, taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The Family Health Coaches also provide social support and will facilitate referrals to community resources.

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Allison Barlow · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-03-31
Completion
2023-08-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05424471 on ClinicalTrials.gov