Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Change in SSB consumption among infants due to water insecurity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Indian ethnicity
- •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
排除标准
- •Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
- •Unwilling to be randomized
结局指标
主要结局
Change in SSB consumption among infants due to water insecurity
时间窗: 6-months of age
To determine the impact of water insecurity on SSB consumption among infants between 3 months and 6 months of age.
Reduction in SSB initiation and frequency among infants up to 12-months of age
时间窗: 12-months of age
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 months and 12 months of age
Change in optimal complementary feeding and responsive parenting practices in mothers who receive FSN vs controls
时间窗: 3-months and 12-months of age
To determine the effectiveness of FSN to promote optimal complementary feeding and responsive parenting practices.
次要结局
- Reduction in SSB intake among mothers and infants due to provision of water(6-months to 9-months of age)
- Change in oral health outcomes in infants in the FSN intervention vs control infants(Up to 12-months postpartum)