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

NCT02723266 | Completed DMC

• 1 other identifier: 1R01NR014831-01A1
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

American Indian, Alaska Native Adolescents; Preconception Counseling; Reproductive Health; Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• Reproductive Health Behaviors

  Family-Planning Vigilance Behavior are defined as using effective family planning/abstinence, seeking PC, and initiating discussion with health care professionals . "Effective family planning behaviors" is a weight summary of the teen's most frequently used contraception. Weights will be derived using the annual failure rates for methods of contraception reported in Trussell's algorithm. Rates are transformed into probabilities of failure (0 to 1), 0 = no failure. Overall effectiveness of contraception is computed as 1-Pr \[Failure\]. Combination methods (\> 2 jointly) is the product of the failure probability of the individual methods used jointly. For multiple methods used singly, the overall probability of failure will be computed as the average of the failure probabilities. Subjects who were never sexually active will be given a failure probability of zero

  15 months

• Beliefs and Attitudes

  Beliefs/attitudes Reproductive Health and Diabetes Questionnaire (EHBM scale) Based on the EHBM,\[53, 76, 82\] perceived susceptibility (9 items) and perceived severity (7), perceived benefits (12) of and barriers (15), and self-efficacy (18) (confidence to use FPV); Likert-type (1=strongly disagree to 7=strongly agree).\[76\] Each construct has a composite score; higher= stronger attitudes. (alphas: susceptibility = .74; severity = .94; benefit = .88; barriers = .97; self-efficacy = .96

  15 months

• Knowledge/Decision-Making

  Knowledge/decision-making Reproductive-health Awareness for Teens with DM Quest (Knowledge scale) Multiple choice, based on 100% correctness, subscales: diabetes and pregnancy (28 items); contraception (5); sexuality (7); puberty (3); PC (25); and general family planning (8) (Cronbach alpha .71; test-retest reliability r= 0.76). Split-half differentiates pre- from post-test

  15 Months

• Social Support

  Social Support Reproductive Health and Diabetes Q. (Social Support scale) Social support is the process by which help is obtained from the social network (e.g., mothers/ female guardian) to meet one's needs. Support measure for mothers is the perceived actual support (emotional, appraisal, informational, and instrumental)\[54\] they provided to their daughters for lifestyle management and family planning vigilance. Daughters' measure is perceived available support from their mother for the same behaviors. Summation score of 9 items with responses, "a lot of help" =7 to "no help at all" =1. Higher scores = greater support. Alpha = .92

  15 months

• Initiating Discussion

  Initiating Discussions with M-D Initiating Discussion M-D Scale Teens and mothers respond to 4 yes/no items of actual discussions they have had regarding GDM and reproductive health issues (pregnancy, sexuality, birth control and PC

  15 months

• Lifestyle Management

  Lifestyle Self-Management Lifestyle Self-Management Scale (DM Care Profile) Daughter's adherence is a 3-item scale (1= "not very well done" to 7= "very well done") based on diabetes-prevention self-care management (diet, physical activity, clinic visits).\[84\] Cronbach's alpha from our studies is .75. Culturally-relevant items will be added during Phase 1

  15 months

Secondary Outcomes (3)

• BMI

  15 months

• Hemoglobin A1C values to evaluate Glycemic Control

  15 months

• Number of subjects reporting an unplanned pregnancy

  15 months

Study Arms (2)

Intervention

EXPERIMENTAL

Treatment receives the STOPPING-GDM intervention. Control does not receive the intervention.

Behavioral: STOPPING-GDM

Control

NO INTERVENTION

Control does not receive the intervention.

Interventions

STOPPING-GDM BEHAVIORAL

Educational counseling and skills building Intervention

Intervention

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• natural, adoptive, or step, living with their daughters
• fluent in English

You may not qualify if:

• 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.
• foster mother of an adolescent girl because she may not be a consistent caregiver.

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Colorado, Denver: collaborator
• University of Oklahoma: collaborator
• Sundance Research Institute: collaborator
• St. Regis Mohawk: collaborator
• Indian Health Care Resource Center of Tulsa: collaborator
• Children's Hospital of Philadelphia: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Indian Health Resource Center of Tulsa

Tulsa, Oklahoma, 73114, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nancy O'Bannion, MS

  Indian Health Care Resource Center of Tulsa

  STUDY DIRECTOR

• Jeff Powell, MD

  University of Colorado (Shiprock-subcontract )

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 30, 2016
• Study Start: March 16, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)