Please select the eligibility criteria that correspond to the clinical trial below.
Title: Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months
Brief 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.


Options:
A: Inclusion Criteria:

* Families in the Oahu community who delivered newborns between November 1994 and November 1995
* If enrolled in the control group, must not have been previously enrolled in Hawaii's Healthy Start Program

Exclusion Criteria:

* Insufficient understanding of English
B: Inclusion Criteria:

1. Willingness to participate
2. 14 to 24 years old at the time of conception
3. \< 32 weeks gestation at the time of enrollment
4. Reside within 1 hour (50 miles) of local Indian Health Service medical facility
5. Willingness to undergo random assignment and participate in all aspects of the study

Exclusion Criteria:

1. Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
C: Inclusion Criteria:

1. American Indian ethnicity
2. Female
3. 13 years of age or older
4. Mother to a baby between the ages of 0 and 2.5 months
5. Living within 50 miles of the Northern Navajo Medical Center

Exclusion Criteria:

1. Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
2. Unwilling to be randomized
D: Inclusion Criteria:

* Adult caregiver with a 2-5 year old child
* 2-5 year old child with a caregiver
* Caregiver has a working cell phone and is willing to receive regular text messages as part of study participation
* Caregiver lives within feasible travel distance of data collection site and willing to come for data collection visits at 0, 6 months, 12 months, 18 months and 24 months
* Willingness to be randomized to one of two groups with the understanding that all participants will receive all components of the intervention, randomization simply determines the order in which materials are received
* Valid mailing address where participant can receive mail and packages
* Basic English fluency and literacy sufficient for understanding the intervention materials and completing questionnaires

Exclusion Criteria:

* Adults with no children or whose only children are younger than 2 or older than 5
* Children younger than 2 or older than 5 years of age
* No cell phone or unwilling to receive regular text messages as part of study participation
* Lives beyond feasible travel distance of data collection sites AND/OR planning on moving out of the area within a two year period
* Child has major physical or behavioral disorder (e.g. failure to thrive, severe autism) that would seriously impact study participation
* No valid mailing address
* Unwillingness to accept random allocation to study arm
* Spouse/partner of another caregiver-child pair who is living in same home \& who has already enrolled (e.g. only one adult-child pair per household may be enrolled)

Answer: C