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

NCT05424471 | Completed

• 1 other identifier: 7476 /MOD994
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Sugar Sweetened Beverages

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Birth to 5 years of age

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

  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.

  3 months to 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.

  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.

  3 to 5 years of age

Secondary Outcomes (2)

• 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

Study Arms (2)

Family Spirit Nurture (FSN)

EXPERIMENTAL

Intervention group participants receive 1 Family Spirit Nurture lesson taught by Family Health Coaches. Mothers will receive the 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.

Behavioral: Family Spirit Nurture (FSN)

Control Vehicle Safety

OTHER

Control group participants receive 1 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.

Other: Control Group - Vehicle Safety

Interventions

Family Spirit Nurture (FSN) BEHAVIORAL

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.

Family Spirit Nurture (FSN)

Control Group - Vehicle Safety OTHER

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.

Also known as: Vehicle Safety

Control Vehicle Safety

Eligibility Criteria

• Age: 13 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Johns Hopkins Center for American Indian Health

Shiprock, New Mexico, 87420, United States

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Allison Barlow

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: June 21, 2022
• Study Start: May 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: August 15, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)