Supporting American Indian/Alaska Native Mothers and Daughters in Reducing Gestational Diabetes Risk



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:12 - 20
Updated:4/6/2019
Start Date:March 16, 2018
End Date:March 1, 2020
Contact:Denise Charron-Prochownik, PhD
Email:dcpro@pitt.edu
Phone:412-624-6953

Use our guide to learn which trials are right for you!

The purpose of this study is to modify an existing Reproductive Health intervention for
adolescents with diabetes for Gestational Diabetes and make it culturally appropriate
American Indian/Alaska Native adolescents. The intervention will then be evaluated for
effectiveness in AI/AN female teens at risk for GDM.

Gestational diabetes mellitus (GDM) has escalated to epidemic proportion and can cause
maternal and child complications. GDM is a significant maternal risk factor for subsequent
development of type 2 diabetes (T2D) and places the fetus at increased risk for congenital
morbidity/mortality and for future onset of diabetes. American Indian and Alaska Native
(AI/AN) women are twice as likely to develop GDM and T2D; mostly due to healthcare
disparities (e.g., limited access to resources, lack of culturally relevant programs). The
need for an inexpensive accessible GDM intervention in this population is compelling. The
intervention should be delivered during adolescence and prior to sexual debut. Preconception
counseling (PC) prevents unplanned pregnancies and significantly reduces risks of
complications. If GDM in a previous pregnancy is an indicator of high risk in subsequent
pregnancies, then preventing GDM in a first pregnancy is imperative. For a significant and
innovative shift in paradigm, the Investigators propose a primary prevention PC intervention
for AI/AN adolescent females at risk for GDM to enhance healthy lifestyle behaviors and
family planning vigilance prior to this first pregnancy. The Investigators will target girls
starting at the age of 12 to coincide with both the "Coming-of-Age" rituals for AI/AN girls
during which many receive womanly advice from elder female family members, and the American
Diabetes Association recommendation that PC in all females should start at puberty. This new
directive will require support from the teens' mothers (or their female caregiver) and
well-informed community health care professionals (HCP). Our objective is to adapt our
current PC intervention (validated for teens with diabetes) using a sequential mixed-method
design with a multi-tribal AI/AN community-based participatory research (CBPR) approach
(e.g., Navajo, Cherokee, 40 Oklahoma tribes; 8 project members are AI/AN) by first using
focus groups of teens, mothers, HCP, and Tribal leaders; and then testing this culturally
appropriate PC theory-based intervention named Stopping GDM in AI/AN adolescent females 12 to
<20yrs at risk for GDM (e.g., pre-diabetes or BMI> 85%). Teens and their mothers will receive
the Stopping GDM to raise their awareness of the risks of GDM and benefits of healthy
lifestyle to reduce these risks. By also providing mothers with PC knowledge and skills they
can naturally weave cultural/social influences into their communications with their
daughters. The multi-level intervention will be directed at the individual, familial and
institutional levels simultaneously. AI/AN community-researcher partnerships have been
established. A randomized controlled trial with a 15mos follow-up will test the effects of
receiving online Stopping GDM on mother-daughter (M-D) cognitive/psychosocial and behavioral
outcomes, and daughter family planning vigilance. The final online Stopping GDM program will
be provided at no cost to the Indian Health Service (IHS) for dissemination to all their
sites. HCPs at each clinical facility will be given free access to a continuing education
program for PC training. This proposal provides a unique opportunity for a broad
dissemination to significantly impact all IHS AI/AN female teens at risk for GDM, and help to
prevent them and their future children from developing T2D.

Inclusion Criteria: Daughter(index subject)

- females between the ages of 12 to <20 years

- at risk for GDM (such as having metabolic syndrome, pre-diabetes, or BMI > 85%; and an
A1C < 6.5%)

- fluent in English.

Inclusion criteria: Mother (or significant female caregiver, e.g., grandmother, aunt, adult
sister, stepmother) of daughters at risk for GDM

- natural, adoptive, or step, living with their daughters

- fluent in English

Exclusion Criteria: Daughters:

- A1C > 6.5%, [20, 26] abnormal Glucose Tolerance Test (GTT),

- signs and symptoms of diabetes,

- a history of another chronic illness or mental retardation,

- pregnant at the time of recruitment.

Exclusion Criteria Mothers:

- foster mother of an adolescent girl because she may not be a consistent caregiver.
We found this trial at
1
site
550 South Peoria Avenue
Tulsa, Oklahoma 73114
Phone: 918-382-2220
?
mi
from
Tulsa, OK
Click here to add this to my saved trials