Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months
1 other identifier
interventional
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Mar 2017
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedStudy Start
First participant enrolled
March 29, 2017
CompletedFirst Posted
Study publicly available on registry
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2019
CompletedAugust 11, 2020
August 1, 2020
2.3 years
February 20, 2017
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
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
Study Arms (2)
Family Spirit Nurture (FSN)
EXPERIMENTALThe 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.
Control Program
OTHERThe 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.
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- American Indian ethnicity
- Female
- 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
You may not qualify if:
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
- Unwilling to be randomized
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Center for American Indian Health
Shiprock, New Mexico, 87420, United States
Related Publications (1)
Rosenstock S, Ingalls A, Foy Cuddy R, Neault N, Littlepage S, Cohoe L, Nelson L, Shephard-Yazzie K, Yazzie S, Alikhani A, Reid R, Kenney A, Barlow A. Effect of a Home-Visiting Intervention to Reduce Early Childhood Obesity Among Native American Children: A Randomized Clinical Trial. JAMA Pediatr. 2021 Feb 1;175(2):133-142. doi: 10.1001/jamapediatrics.2020.3557.
PMID: 33165594DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Barlow, PhD
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
April 5, 2017
Study Start
March 29, 2017
Primary Completion
August 1, 2019
Study Completion
October 18, 2019
Last Updated
August 11, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share