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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Family Spirit Nurture (FSN)
* Other: Control Program
* Other: Water Delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Spirit Nurture (FSN)<br>The intervention group (n=68) will receive the Family Spirit Nurture (FSN) home-visiting module, consisting of six 45-minute lessons delivered biweekly by trained local American Indian 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. Lessons are highly visual and interactive, and will incorporate cultural teachings related to infant feeding and nutrition that support aims. All families will receive water delivery of drinking water from 6 to 9 months postpartum. | Behavioral: Family Spirit Nurture (FSN)<br>* 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<br>Other: Water Delivery<br>* 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.<br>|
| Other: Control Program<br>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). Mothers randomized to the control group will receive 3 educational lessons on home safety and child safety proofing. These meaningful topics were selected so as not to dilute measurement on key FSN outcomes and to provide benefit to all study participants. 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. All families will receive water delivery of drinking water from 6 to 9 months postpartum. | Other: Control Program<br>* 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.<br>Other: Water Delivery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in SSB initiation and frequency among infants up to 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 | 12-months of age | 
| Change in optimal complementary feeding and responsive parenting practices in mothers who receive FSN vs controls | To determine the effectiveness of FSN to promote optimal complementary feeding and responsive parenting practices. | 3-months and 12-months of age | 
| Change in SSB consumption among infants due to water insecurity | To determine the impact of water insecurity on SSB consumption among infants between 3 months and 6 months of age. | 6-months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in SSB intake among mothers and infants due to provision of water | Explore if provision of water to families reduces SSB intake among mothers and infants | 6-months to 9-months of age | 
| Change in oral health outcomes in infants in the FSN intervention vs control infants | Explore if infants in the FSN intervention have better oral health outcomes than control infants | Up to 12-months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugar, Sweetened, Beverages