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NCT ID: NCT05424471 Completed - Obesity Clinical Trials

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

PECO1-LTF
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03101943 Completed - Obesity Clinical Trials

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

Start date: March 29, 2017
Phase: N/A
Study type: Interventional

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.