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

The investigators will conduct a pilot randomized 1:1 controlled trial with 136 mother-infant dyads. Participants will be pre-screened for water insecurity and distributed equally across the two study arms using stratified block randomization. The intervention group (n=68) will receive the FSN home-visiting module, consisting of six 45-minute lessons delivered biweekly by trained local AI Family Health Coaches (FHCs), from 3 to 6 months postpartum. The lessons focus on elimination or reduction of Sugar Sweetened Beverages (SSBs) among infants while teaching mothers complementary feeding and responsive parenting practices. The control group (n=68) will receive three home-based lessons with home safety information (injury prevention is a priority identified by Navajo leadership that does not interfere with study questions). All families will receive delivery of drinking water from 6 to 9 months postpartum. Through this staggered design, the investigators will evaluate the impact of the FSN on infant feeding practices associated with increased risk for early childhood obesity, with a primary focus on delaying introduction of infant's SSB intake. The investigators will also be able to evaluate the impact of the availability of potable water on SSB intake, with or without family education. In addition, participants will have the opportunity to provide additional consent for a nested oral health study to evaluate the impact of the FSN curriculum and water provision on infant oral health indicators.

Methods:

Study implementation will include four phases:

Phase 1 (Referral, Recruitment, Consent, Baseline Assessment and Randomization): Potentially eligible mothers will be referred to our study staff, who will screen for eligibility, consent/assent mothers, conduct baseline assessment, and assign randomization status. Randomization will be assigned after the completion of the baseline assessment, including scoring of the participant's water insecurity status. Two randomization lists (one for water secure mothers and one for water insecure mothers) will be created prior to study initiation using STATA 14 statistical software37.

Part 2 (Home-Based Education Intervention): Local FHCs, trained and employed by Johns Hopkins, will deliver either the intervention (6-session FSN) or the control condition (3- Home-Safety Lessons) between 3 to 6 months postpartum.

Part 3 (Water Delivery): All participants will have drinking water delivered to their home from 6 to 9 months postpartum. FHCs will deliver water either weekly or less often, depending on needs of family. The amount of water delivered will be based on number of adults and children residing in home during this period of the study.

Part 4 (Assessment): Our assessment post-baseline consists of a mixed-methods assessment, including maternal self-reports and maternal FHC-administered interviews collected using REDCap at 4, 6, 7, 8, 9 and 12 months postpartum and maternal and infant medical chart reviews. If consent is given for the nested oral health study, the additional assessments will include a maternal self-report measure, collection and microbiologic testing of infant plaque and saliva, an infant oral examination, tooth eruption evaluations and infant medical and dental chart reviews.

Inclusion criteria

• American Indian ethnicity
• Female
• 13 years of age or older
• Mother to a baby between the ages of 0 and 2.5 months
• Living within 50 miles of the Northern Navajo Medical Center

Exclusion criteria

• Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
• Unwilling to be randomized