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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
330
Community Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.
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.
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.
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.
Deep Griha Society
Pune, Maharashtra, India
RECRUITINGNumber of participants who completed OGTT during the first year postpartum
Time frame: Up to 1 year and 3 months
Number of participants who accept OGTT screening for GDM during enrollment
Time frame: Within 3 months of enrollment
Number of participants with GDM who have abnormal postpartum OGTT results
Time frame: Up to 1 year and 3 months
Median time in months participants complete T2DM screening within the first 12 months postpartum.
Time frame: Up to 1 year and 3 months
Percentage of participants with abnormal OGTT who complete a single clinic visit for T2DM care
Time frame: Up to 2 years
Percentage of participants with abnormal OGTT who complete a second visit by 24 months postpartum
Time frame: Up to 2 years
Number of participants with any pregnancy complications, including high infant birthweight and presence of congenital anomalies.
Time frame: Up to 5 months
Number of women with abnormal OGTT who get tests including hemoglobin, lipid profile, creatinine.
Time frame: Up to 2 years
Mean postprandial incremental glucose peak
Mean peak postprandial glucose as measured by continuous glucose monitor
Time frame: Periprocedural
Mean amplitude of glycemic excursions
Mean amplitude of glucose excursions as measured by continuous glucose monitor
Time frame: Periprocedural
Time in normal glucose range
Time spent in normal glucose range as measured by continuous glucose monitor
Time frame: Periprocedural
Acceptability of the nutrition intervention
Number of participants expressing acceptability of aspects of the intervention, evaluated using the Theoretical Framework of Acceptability
Time frame: After postpartum follow-up for a period of 3 months
Feasibility of the nutrition intervention
Evaluated using qualitative participant interviews
Time frame: After postpartum follow-up for a period of 3 months
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