Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Endocrinology, Other |
| Healthy: | No |
| Age Range: | 13 - Any |
| Updated: | 10/28/2018 |
| Start Date: | March 29, 2017 |
| End Date: | December 31, 2019 |
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.
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.
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.
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.
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
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