Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months

Summary

This study aims to assess the impact of a brief home-visiting module, called "Family Spirit Nurture" (FSN), on American Indian (AI) parent feeding practices associated with increased risk for early childhood obesity, with a primary focus on delaying introduction of infants' Sugar Sweetened Beverage (SSB) (including soda, energy drinks, juice with added sugar and other drinks with added sugar) intake while teaching mothers complementary feeding and responsive parenting practices. The investigators will also assess how water insecurity may moderate parents' feeding of SSBs to young children. Finally, the investigators will explore whether maternal knowledge of oral health practices and/or reduction of infants' SSB intake influences early indicators of infant's oral health (i.e., infants' oral microbiome and plaque formation). Our evaluation will employ a randomized controlled design, in which the control condition receives a beneficial home-safety educational model and assistance in safety proofing their homes for small children. Assessments in both groups will occur at baseline (between 6 and 10 weeks postpartum) and 4 months, 6 months, 9 months and 12 months postpartum.

Primary Aims:

Aim 1: To determine the effectiveness of the brief (6 lessons) FSN home-visiting parent feeding practice module on reducing SSB initiation and frequency among infants between 3 and 12 months of age. Hypothesis 1: Infants whose mothers receive FSN vs. controls will be less likely to introduce SSBs between 3 and 12 months of age.

Aim 2: To determine the effectiveness of FSN to promote optimal complementary feeding and responsive parenting practices. Hypothesis 2: Mothers who receive FSN vs. controls will be more likely to practice recommended complementary feeding and responsive parenting practices between 3 and 12 months of age.

Aim 3: To determine the impact of water insecurity on SSB consumption among infants between 3 and 6 months of age. Hypothesis 2: Parents who report water insecurity vs. those who do not will be more likely to give infants SSBs between 3 and 6 months of age.

Secondary Aims:

Secondary Aim 1: To explore if provision of water to families reduces SSB intake among mothers and infants ages 6 to 9 months of age.

Secondary Aim 2: To explore if infants in the FSN intervention have better oral health outcomes than control infants up to 12 months postpartum.

Conditions

• Obesity
• Water; Lack of
• Breast Feeding
• Tooth Erosion
• Dental Plaque
• Infant Obesity
• Feeding Behavior
• Mother-Child Relations
• Dietary Habits
• Dental Caries

Interventions

BEHAVIORAL

Family Spirit Nurture (FSN)

The FSN intervention will be conducted over a 6-month period. Participants in the intervention group will receive 6- 45 minute lessons in their home or a private place of their choosing. The lessons focus on elimination or reduction of Sugar Sweetened Beverages (SSBs) among infants while teaching mothers complementary feeding and responsive parenting practices

OTHER

Control Program

The control group will receive three home-based lessons with home safety information.Lessons will be delivered monthly (at 3, 4 and 5 months postpartum) in the same format as the FSN lessons, by trained FHCs in the home of the participant or in a private place of their choosing.

OTHER

Water Delivery

Drinking water will be delivered to the household of each participant (both in the FSN intervention and control groups) from 6 to 9 months postpartum. The amount of water will be determined by the number of children and adults living in the household at the time of water delivery. The first delivery of water will occur at the time of the 6-month evaluation and the last delivery will occur at the time of the 9-month evaluation. Water will be delivered as often as weekly. Those families who do not need weekly water delivery (based on their preference and their usage of the first delivery of water) will receive water less frequently.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Allison Barlow, PhD · 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

2017-03-29

Primary Completion

2019-08-01

Completion

2019-10-18

Countries

• United States

Study Locations