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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK092750-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine whether a 14 week intervention is successful in improving outcomes for women with gestational diabetes mellitus and their infants.
Women who are diagnosed with gestational diabetes are at increased risk for developing prediabetes and type 2 diabetes. To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with gestational diabetes. Programs are needed that intervene in the prenatal period to teach women the importance of breastfeeding to improve metabolic control and infant health and continue after birth to promote improved nutrition and exercise patterns and weight loss. Using a two-group, repeated measures experimental design, this proposed study will test a 14-week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise education, coping skills training, and physical activity (Phase I) and 3 months of continued monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy. Trends in breastfeeding duration and intensity, maternal infant feeding behavior, infant growth trajectory (weight-for-length) will also be measured. A total of 100 African American, bilingual Hispanic, and non-Hispanic White women diagnosed with gestational diabetes will be inducted and randomized by site to either the experimental or wait-list control group. Data will be collected at Time 1 (Baseline at 22-36 weeks pregnant), Time 2 (6 weeks postpartum), Time 3 (4 months postpartum and completion of Phase I), Time 4 (7 months postpartum and completion of Phase II), and Time 5 (10 months postpartum and after 3 months on their own). Primary maternal outcomes will include fasting blood glucose and weight (BMI). Secondary maternal outcomes will include clinical outcomes (oral glucose tolerance test, insulin levels, Homeostasis Model Assessment calculation, Hemoglobin A1c, complete lipid panel, and blood pressure); adiposity (waist circumference, triceps and subscapular skin folds); health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days); and self-efficacy (Eating Self-Efficacy, Exercise Self-Efficacy Scale, and Breastfeeding Self-Efficacy Scale). Infant outcomes will include data on weight status (weight-for-length) and breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding). Data analysis will include analysis of field notes, post-intervention interviews, and recruitment and retention efforts. Linear mixed-effects random coefficients models will be constructed to measure the effects of the intervention compared to the wait-list control group. Increasing breastfeeding and decreasing overweight in postpartum women who were diagnosed with gestational diabetes may both improve maternal glucose homeostasis and weight and stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | Breastfeeding, progression to type 2 diabetes, nutrition, and exercise education, coping skills training, exercise training, a home-based exercise program and educational and motivational text messaging. |
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| Wait-listed control group | No Intervention | Wait-listed control group receive usual care delivered by their health care provider and after completion of their time in the study they are offered the intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Using a two-group, repeated measures experimental design, this proposed study will test a 14-week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise education, coping skills training, and physical activity (Phase I) and 3 months of continued monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| fasting blood glucose | Change in fasting blood glucose in mothers | Baseline to 10 months postpartum |
| weight (body mass index) | Change in weight (body mass index)in mothers | Baseline to 10 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| oral glucose tolerance test | Change in oral glucose tolerance test in mothers | Baseline to 10 months postpartum |
| insulin levels | Change in insulin levels in mothers |
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Inclusion Criteria:
Women between 22-36 weeks of pregnancy who are diagnosed with GDM
A diagnosis of GDM during the current pregnancy by two or more 100g Oral Glucose Tolerance Test (OGTT) values exceeding established thresholds (fasting 95, 1h 180, 2h 155, 3h 140 mg/dL)
Age 18-45 years old
A pre-pregnancy body mass index > 25kg/m2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Berry, PhD, ANP-BC | University of North Carolina, Chapel Hill | Principal Investigator |
| Alison Stuebe, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC-Rex Health Care | Raleigh | North Carolina | 27607 | United States | ||
| WakeMed |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27782758 | Derived | Stuebe AM, Bonuck K, Adatorwovor R, Schwartz TA, Berry DC. A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes. Breastfeed Med. 2016 Dec;11(10):504-513. doi: 10.1089/bfm.2016.0069. Epub 2016 Oct 26. | |
| 24112417 | Derived | Berry DC, Neal M, Hall EG, Schwartz TA, Verbiest S, Bonuck K, Goodnight W, Brody S, Dorman KF, Menard MK, Stuebe AM. Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study. BMC Pregnancy Childbirth. 2013 Oct 10;13:184. doi: 10.1186/1471-2393-13-184. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D001835 | Body Weight |
| D009765 | Obesity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D015596 | Nutrition Assessment |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
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|
|
| Baseline to 10 months postpartum |
| homeostasis model assessment | Change in homeostasis model assessment calculation in mothers | Baseline to 10 months postpartum |
| hemoglobin A1c | Change in hemoglobin A1c in mothers | Baseline to 10 months postpartum |
| complete lipid panel | Change in complete lipid panel in mothers | Baseline to 10 months postpartum |
| blood pressure | Change in blood pressure in mothers | Baseline to 10 months postpartum |
| adiposity | Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers | Baseline to 10 months |
| health behaviors | Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers | Baseline to 10 months postpartum |
| self-efficacy | Change in self-efficacy in mothers | Baseline to 10 months postpartum |
| infant weight status | weight status (weight-for-length) in children | Birth to 10 months |
| breastfeeding | Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants | Birth to 10 months |
| Raleigh |
| North Carolina |
| 27610 |
| United States |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |