Community Health Worker-Led Postpartum Diabetes Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home Based Testing, Clinic Based Screening, Food order nutritional intervention before meals, Food order nutritional intervention after meals.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Gestational Diabetes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India
Overview
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
- Behavioral Home 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. - Behavioral Clinic 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 supplement Food 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 supplement Food 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.
Primary outcome measures
- Number of participants who completed OGTT during the first year postpartum [Time frame: Up to 1 year and 3 months]
Secondary outcome measures (12)
- 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 [Time frame: Periprocedural]
- Mean amplitude of glycemic excursions [Time frame: Periprocedural]
- Time in normal glucose range [Time frame: Periprocedural]
- Acceptability of the nutrition intervention [Time frame: After postpartum follow-up for a period of 3 months]
- Feasibility of the nutrition intervention [Time frame: After postpartum follow-up for a period of 3 months]
Eligibility criteria
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
- Unwilling or unable to participate in study procedures
- Unwilling or unable to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
India · 1 center
- Deep Griha Society — Pune
Identifiers
NCT: NCT06209411 · 22-11025408 · 1R01HD112141-01