Supporting American Indian/Alaska Native Mothers and Daughters in Reducing Gestational Diabetes Risk
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|ClinicalTrials.gov Identifier: NCT02723266|
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Mellitus||Behavioral: STOPPING-GDM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Supporting American Indian/Alaska Native Mothers and Daughters in Reducing Gestational Diabetes Risk|
|Actual Study Start Date :||March 16, 2018|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||March 1, 2020|
Treatment receives the STOPPING-GDM intervention. Control does not receive the intervention.
Educational counseling and skills building Intervention
No Intervention: Control
Control does not receive the intervention.
- Reproductive Health Behaviors [ Time Frame: 15 months ]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
- Beliefs and Attitudes [ Time Frame: 15 months ]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). Each construct has a composite score; higher= stronger attitudes. (alphas: susceptibility = .74; severity = .94; benefit = .88; barriers = .97; self-efficacy = .96
- Knowledge/Decision-Making [ Time Frame: 15 Months ]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
- Social Support [ Time Frame: 15 months ]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) 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
- Initiating Discussion [ Time Frame: 15 months ]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
- Lifestyle Management [ Time Frame: 15 months ]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). Cronbach's alpha from our studies is .75. Culturally-relevant items will be added during Phase 1
- BMI [ Time Frame: 15 months ]Body Mass Index (BMI) BMI percentile a standard parameter for obesity will be the measured weight (kilograms) divided by measured height using a stadiometer (meters) squared. Change in BMI will be analyzed. Percentiles will be specific to sex and month of age using algorithms by the Center for Disease Control. BMI z scores will also be calculated. Identical scales and stadiometers, provided by the study, will be calibrated according to the manufacturer. Protocols/ categories from the SEARCH study will be used.
- Hemoglobin A1C values to evaluate Glycemic Control [ Time Frame: 15 months ]Glycosylated Hemoglobin (A1C) A1C is a standard index of long-term glycemic control, reflecting 3-month average blood glucose levels. Clinic A1C values will be recorded from the subjects' medical records, and entered into the online database. Each site uses the same standardized method for obtaining A1C samples. Blood will be collected from a finger stick and analyzed immediately. Each site will use the same manufacturer's calibration techniques . The investigators will evaluate changes in glycemic control per the categories in the American Diabetes Association guidelines. A Glycosylated Hemoglobin (A1C) > 6.5% is an exclusion criteria.
- Number of subjects reporting an unplanned pregnancy [ Time Frame: 15 months ]Self Report of Unplanned Pregnancy (no or yes) since last visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723266
|Contact: Denise Charron-Prochownik, PhDfirstname.lastname@example.org|
|Contact: Andrea Fischl, PhDemail@example.com|
|United States, Oklahoma|
|Indian Health Resource Center of Tulsa||Recruiting|
|Tulsa, Oklahoma, United States, 73114|
|Contact: Nancy O'Banion, MS 918-382-2220 nobanion@IHCRC.org|
|Contact: Sharnella Goudeau, RN 918-619-4304 firstname.lastname@example.org|
|Study Director:||Nancy O'Bannion, MS||Indian Health Care Resource Center of Tulsa|
|Study Director:||Jeff Powell, MD||University of Colorado (Shiprock-subcontract )|