Clinical trial NCT02723266: Supporting American Indian/Alaska Native Mothers and Daughters in Reducing Gestational Diabetes Risk
Official title: Supporting American Indian/Alaska Native Mothers and Daughters in Reducing Gestational Diabetes Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: American Indian, Alaska Native Adolescents
Preconception Counseling
Reproductive Health
Gestational Diabetes Mellitus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: University of Oklahoma
name: Sundance Research Institute
name: St. Regis Mohawk
name: Indian Health Care Resource Center of Tulsa
name: Children's Hospital of Philadelphia
name: Brigham and Women's Hospital
First posted: 2016-03-30
Enrollment: 398
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reproductive Health Behaviors
timeFrame: 15 months
measure: Beliefs and Attitudes
timeFrame: 15 months
measure: Knowledge/Decision-Making
timeFrame: 15 Months
measure: Social Support
timeFrame: 15 months
measure: Initiating Discussion
timeFrame: 15 months
measure: Lifestyle Management
timeFrame: 15 months
Secondary outcomes:
measure: BMI
timeFrame: 15 months
measure: Hemoglobin A1C values to evaluate Glycemic Control
timeFrame: 15 months
measure: Number of subjects reporting an unplanned pregnancy
timeFrame: 15 months
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Indian Health Resource Center of Tulsa
state: Oklahoma
Study officials:
affiliation: Indian Health Care Resource Center of Tulsa
name: Nancy O'Bannion, MS
role: STUDY_DIRECTOR
affiliation: University of Colorado (Shiprock-subcontract )
name: Jeff Powell, MD
role: STUDY_DIRECTOR
References: