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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101943
• Other study ID #: 7476
• Status: Completed
• Phase: N/A
• Start date: March 29, 2017
• Est. completion date: October 18, 2019

Study information

• Verified date: August 2020
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Family Spirit Nurture (FSN)
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

Other:
• Control Program
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.
• Water Delivery
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health	Shiprock	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

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