Gestational Diabetes MellitusNCT02723266
Supporting American Indian/Alaska Native Mothers and Daughters in Reducing Gestational Diabetes Risk
A study testing STOPPING-GDM in people with Gestational Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- STOPPING-GDM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indian Health Resource Center of Tulsa
Tulsa, Oklahoma, 73114
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- STOPPING-GDM
- Keywords
- American Indian, Alaska Native Adolescents, Preconception Counseling, Reproductive Health, Gestational Diabetes Mellitus
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPPING-GDMBehavioural
Educational counseling and skills building Intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Treatment receives the STOPPING-GDM intervention. Control does not receive the intervention. Receives: Behavioral: STOPPING-GDM |
| Control | No intervention | Control does not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 15 months
Secondary outcomes (3)
BMI
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.
Measured: 15 months
Hemoglobin A1C values to evaluate Glycemic Control
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.
Measured: 15 months
Number of subjects reporting an unplanned pregnancy
Self Report of Unplanned Pregnancy (no or yes) since last visit.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start16 Mar 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of Oklahoma, Sundance Research Institute, St. Regis Mohawk, Indian Health Care Resource Center of Tulsa, Children's Hospital of Philadelphia, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Denise Charron-Prochownik, University of Pittsburgh
- Investigators
- Nancy O'Bannion, MS, Study director, Indian Health Care Resource Center of TulsaJeff Powell, MD, Study director, University of Colorado (Shiprock-subcontract )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723266
- Sponsor's protocol ID
- 1R01NR014831-01A1
- Status last verified
- Oct 2019
- First submitted
- 1 Mar 2016
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is our intention to make all data generated from this proposal freely available. The primary mechanism of data dissemination will be through submission of abstracts to regional, national, and international meetings and the submission of manuscripts. The principal investigator will serve as liaison with other investigators in the sharing of additional materials if necessary.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting American Indian/Alaska Native Mothers and Daughters in Reducing Gestational Diabetes Risk
- ClinicalTrials.gov ID
- NCT02723266
- Acronym / sponsor ID
- 1R01NR014831-01A1
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- American Indian, Alaska Native Adolescents, Preconception Counseling, Reproductive Health, Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of Oklahoma, Sundance Research Institute, St. Regis Mohawk, Indian Health Care Resource Center of Tulsa, Children's Hospital of Philadelphia, Brigham and Women's Hospital
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: STOPPING-GDMTreatment receives the STOPPING-GDM intervention. Control does not receive the intervention. |
| Control | No intervention | –Control does not receive the intervention. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOPPING-GDMEducational counseling and skills building Intervention | Behavioural | Intervention |
Primary outcome
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).[76] 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)[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
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).[84] Cronbach's alpha from our studies is .75. Culturally-relevant items will be added during Phase 1
3 secondary outcomes
BMI
Time frame: 15 months
Hemoglobin A1C values to evaluate Glycemic Control
Time frame: 15 months
Number of subjects reporting an unplanned pregnancy
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Individual participant dataSharing planned: Yes. It is our intention to make all data generated from this proposal freely available. The primary mechanism of data dissemination will be through submission of abstracts to regional, national, and international meetings and the submission of manuscripts. The principal investigator will serve as liaison with other investigators in the sharing of additional materials if necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy O'Bannion, MS study director
Indian Health Care Resource Center of Tulsa
Jeff Powell, MD study director
University of Colorado (Shiprock-subcontract )
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOPPING-GDM in people with Gestational Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproductive Health Behaviors (time frame: 15 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.