Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD112141-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.
The purpose of the project is to determine the effectiveness of a community health worker (CHW)-delivered home based oral glucose tolerance test (OGTT) (home testing arm) versus referral for clinic-based screening (referral arm) and evaluate the implementation of the CHW-delivered programs.
Design and Project Type: This hybrid type II effectiveness- implementation cluster randomized trial aims to evaluate if CHWs can improve postpartum type 2 diabetes mellitus (T2DM) screening in the urban slums of Pune, India. Slum communities will be randomized in equal number to one of two study arms. Participants in both arms will receive CHW-delivered OGTT during pregnancy to screen for GDM. For women diagnosed with gestational diabetes mellitus (GDM), the investigators will evaluate two strategies to improve T2DM screening in the first year postpartum: CHW-delivered home based OGTT (home testing arm) versus referral for clinic-based screening (referral arm). A substudy will also evaluate a timed protein-fiber supplement in glucose control.
Description of Intervention: The intervention is postpartum screening for T2DM which involves oral intake of a glucose load and subsequent measurement of fasting and postprandial point of care blood glucose measurement. A substudy will also provide a timed protein-fiber supplement.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Referral Arm | Active Comparator | CHW will contact participants with GDM from communities in the referral arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education and 2) referral to the postnatal clinic at a government hospital for T2DM screening. |
|
| Home Testing Arm | Experimental | CHW will contact participants with GDM from communities in the home-based testing arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education, and 2) offer home-based OGTT. |
|
| Protein-fiber food supplement Before Meals | Other | Food order nutritional intervention, protein-fiber supplement is given before meals for 4 days, then a 4 day washout period, then given after meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up. |
|
| Protein-fiber food supplement after meals | Other | Food order nutritional intervention, protein-fiber supplement is given after meals for 4 days, then a 4 day washout period, then given before meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Based Testing | Behavioral | Community Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who completed OGTT during the first year postpartum | Up to 1 year and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who accept OGTT screening for GDM during enrollment | Within 3 months of enrollment | |
| Number of participants with GDM who have abnormal postpartum OGTT results | Up to 1 year and 3 months |
Not provided
Inclusion Criteria:
Pregnant Women:
Community Health Workers:
Clinicians:
Ministry of Health Officials
Exclusion Criteria:
Pregnant Women:
CHW, Clinicians, Ministry of Health Officials
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jyoti S Mathad, MD, MSc | Contact | 646-962-8140 | jsm9009@med.cornell.edu | |
| Radhika Sundararajan, MD, PhD | Contact | 646-962-8140 | ras9199@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jyoti Mathad, MD, MSc | Weill Cornell Medicine Center for Global Health | Principal Investigator |
| Radhika Sundararajan, MD, PhD | Weill Cornell Medicine Center for Global Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deep Griha Society | Recruiting | Pune | Maharashtra | 411001 | India |
The investigators will remove all identifying information from this data. However, because this study will take place in small communities in Pune, the investigators believe that it is possible that participants with unusual characteristics could be deductively identified. Therefore, the investigators will make the de-identified data available to qualified investigators under a data-sharing agreement that stipulates: (a) a commitment that the data will only be used for research purposes and not to identify individuals; (b) that the data security will be assured using appropriate information technology; and (c) that the data set will be destroyed following the analysis.
Not provided
The investigators will publish data during and at the completion of this project, consistent with standard scientific practices, in peer-reviewed, open access journals. The investigators will also share our findings at national and international conferences and with local stakeholders in study areas. Research data sets that document, support, and validate our research findings will be made available under appropriate data-sharing agreements after the main findings from the final research data set have been accepted for publication.
The investigators will make the de-identified data available to qualified investigators under the following data-sharing agreement: (a) a commitment that the data will only be used for research purposes and not to identify individuals; (b) that the data security will be assured using appropriate information technology; and (c) that the data set will be destroyed following the analysis.
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Cluster Randomized Trial
Not provided
Not provided
Not provided
Not provided
| Clinic Based Screening | Behavioral | Community Health Workers (CHWs) will offer referral to clinic based OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education. |
|
| Food order nutritional intervention before meals | Dietary Supplement | Protein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement before meals (protein-fiber first) or consume it after meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups. |
|
| Food order nutritional intervention after meals | Dietary Supplement | Protein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement after meals (protein-fiber first) or consume it before meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups. |
|
| Median time in months participants complete T2DM screening within the first 12 months postpartum. | Up to 1 year and 3 months |
| Percentage of participants with abnormal OGTT who complete a single clinic visit for T2DM care | Up to 2 years |
| Percentage of participants with abnormal OGTT who complete a second visit by 24 months postpartum | Up to 2 years |
| Number of participants with any pregnancy complications, including high infant birthweight and presence of congenital anomalies. | Up to 5 months |
| Number of women with abnormal OGTT who get tests including hemoglobin, lipid profile, creatinine. | Up to 2 years |
| Mean postprandial incremental glucose peak | Mean peak postprandial glucose as measured by continuous glucose monitor | Periprocedural |
| Mean amplitude of glycemic excursions | Mean amplitude of glucose excursions as measured by continuous glucose monitor | Periprocedural |
| Time in normal glucose range | Time spent in normal glucose range as measured by continuous glucose monitor | Periprocedural |
| Acceptability of the nutrition intervention | Number of participants expressing acceptability of aspects of the intervention, evaluated using the Theoretical Framework of Acceptability | After postpartum follow-up for a period of 3 months |
| Feasibility of the nutrition intervention | Evaluated using qualitative participant interviews | After postpartum follow-up for a period of 3 months |
| D004700 | Endocrine System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |