Obesity Clinical Trial
Official title:
Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months
NCT number | NCT03101943 |
Other study ID # | 7476 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 29, 2017 |
Est. completion date | October 18, 2019 |
Verified date | August 2020 |
Source | Johns Hopkins Bloomberg School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | October 18, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 13 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Center for American Indian Health | Shiprock | New Mexico |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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