Diabetes Mellitus, Type 2, Gestational Diabetes
Conditions
Keywords
Community Health Workers, Type 2 Hybrid Effectiveness-Implementation Trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHome Based Testing
Community Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.
BEHAVIORALClinic Based Screening
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.
DIETARY_SUPPLEMENTFood order nutritional intervention before meals
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.
DIETARY_SUPPLEMENTFood order nutritional intervention after meals
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.
Sponsors
Weill Medical College of Cornell University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Cluster Randomized Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Pregnant Women: * Pregnant woman residing in one of pre-selected slum communities * 18 years or older * ≥ 24 weeks gestational age (as determined by self-reported last menstrual period or ultrasound) * Meet or exceed the threshold for GDM as determined by the CHW-delivered fasting OGTT * Agrees to study procedures, including in-person visits with the CHW postpartum if they are diagnosed with GDM Community Health Workers: * 18 years or older * Willingness to participate in study procedures and recruit eligible pregnant women * Agreement with goals of the study * Resides in one of the study communities * Willing to participate in surveys and interviews Clinicians: * 18 years or older * Diabetes or obstetrics physicians * In a patient-facing position for over 1 year Ministry of Health Officials * 18 years or older * Employed by the Ministry of Health and Family Welfare, Maternal Health Division
Exclusion criteria
Pregnant Women: * Preexisting diabetes diagnosis prior to current pregnancy * Unable to tolerate food/ drink and remain fasting for 8 hoursUnwilling or unable to participate in study procedures * Unwilling or unable to provide informed consent CHW, Clinicians, Ministry of Health Officials 1. Unwilling or unable to participate in study procedures 2. Unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who completed OGTT during the first year postpartum | Up to 1 year and 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | Periprocedural | Mean peak postprandial glucose as measured by continuous glucose monitor |
| Mean amplitude of glycemic excursions | Periprocedural | Mean amplitude of glucose excursions as measured by continuous glucose monitor |
| Time in normal glucose range | Periprocedural | Time spent in normal glucose range as measured by continuous glucose monitor |
| Acceptability of the nutrition intervention | After postpartum follow-up for a period of 3 months | Number of participants expressing acceptability of aspects of the intervention, evaluated using the Theoretical Framework of Acceptability |
| Feasibility of the nutrition intervention | After postpartum follow-up for a period of 3 months | Evaluated using qualitative participant interviews |
Countries
India
Contacts
CONTACTJyoti S Mathad, MD, MSc
CONTACTRadhika Sundararajan, MD, PhD
PRINCIPAL_INVESTIGATORJyoti Mathad, MD, MSc
Weill Cornell Medicine Center for Global Health
PRINCIPAL_INVESTIGATORRadhika Sundararajan, MD, PhD
Weill Cornell Medicine Center for Global Health
Outcome results
None listed