Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05424471 |
| Other study ID # |
7476 /MOD994 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
August 15, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Johns Hopkins Bloomberg School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study extends follow up on of Native American (NA) mothers and their children (now age
3-5 years) enrolled in the 1:1 randomized controlled trial of the Family Spirit Nurture (FSN)
intervention designed to prevent early childhood obesity (PECO 1). The investigators will
examine whether positive FSN impacts on sugar sweetened beverage (SSB) consumption and
healthy growth in the first year of life were sustained. The investigators will also examine
the effects of the emergency COVID-19 water solutions on water insecurity, early childhood
SSB consumption, and growth, and explore how COVID-19 affected child feeding patterns and
weight status either through changes in maternal mental health or household food access.
Description:
Primary Aims
Aim 1. Determine the longer-term effectiveness of the brief FSN intervention on reducing SSB
consumption, increasing water intake, and promoting healthy growth status up to 5 years of
age.
Aim 2. Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency
water response efforts, on water insecurity, children's water intake and SSB consumption with
or without previous FSN intervention. Positive findings would provide leverage to promote
water solutions and water equity.
Secondary Aims
Secondary Aim 1. Determine whether providing a booster lesson at 4 years of age targeting age
appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water
intake impacts SSB consumption and water intake between 4 and 4.5 years of age and child
growth between 4 and 5 years of age.
Secondary Aim 2. Describe how COVID-19 affected child feeding patterns and weight status
either through maternal depression and anxiety or changes in food access.
This follow-up study will builds upon a 1:1 randomized controlled trial of the Family Spirit
Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1).
Methods:
A long-term follow-up evaluation will be conducted with n=110 of the randomized mother-child
dyads (90% of the participants that completed the PECO 1 study) when the children are between
4 - 5 years of age.
Eligible participants will complete a 4 year follow-up assessment after reconsent when the
children are 4 years of age. All participants will maintain their randomization status and
receive one age appropriate lesson specific to their study group. The intervention group
(n=55) will receive one FSN lesson focused on age-appropriate parental feeding practices,
including snack routines, avoidance of SSBs, and increased water intake. The control group
(n=55) will receive one injury prevention lesson focused on vehicle safety. An endline
follow-up assessment will be completed by all reconsented participants after three months of
the 4 year follow-up assessment. Maternal and child medical chart review will be conducted by
trained study staff after the child turns 5 years old. Medical chart reviews will collect
data on maternal BMI (as a possible moderator of child growth) and child growth.
During the COVID-19 pandemic as part of the emergency response on the Navajo Nation, a subset
of study participants who previously reported water insecurity (n=50) received point-of-use
(POU) water filters. Water filters were evenly distributed between the intervention (n=25)
and control groups (n=25).
Study implementation will include three phases:
Phase 1 (Reconsent, Reenroll, and 4 year Follow-up Assessment):
Study staff will re-approach randomized mother/child dyads when the child is 4 years of age
to complete the informed consent process for the follow-up component. Participants will
maintain their original randomization status and complete a 4 year follow-up assessment that
consists of a mixed-methods approach.
Phase 2 (Booster Lesson):
Local FHCs, trained and employed by Johns Hopkins, will deliver either the intervention (1-
FSN lesson) or the control condition (1- Vehicle-Safety Lesson) shortly after the 4 year
follow-up assessment when the child is 4 years of age. With participant permission, lesson
visits will be audio recorded for quality assurance, using digital audio recorders. A random
10% of audio recordings will be reviewed and rated to ensure fidelity to the curriculum and
to facilitate staff training and supervision.
Phase 3 (Endline Follow-up Assessment and Medical Chart Reviews):
Three months after the 4 year follow-up assessment, participants will complete an endline
follow-up assessment. The endline follow-up assessment will be the same assessment battery as
the 4 year follow-up assessment. Maternal and child medical chart reviews will be conducted
by trained study staff after the child is 5 years of age. Weight and height data will be
collected from child's medical charts (birth through 5 years of age). Data may be collected
any time during the 5th year of life as timing of the five year check up can vary. Maternal
BMI will be collected from maternal medical chart reviews as a possible moderator of child
growth.
