A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Number of participants who completed OGTT during the first year postpartum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Referral Arm
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.
干预措施: Clinic Based Screening (Behavioral)
Home Testing Arm
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.
干预措施: Home Based Testing (Behavioral)
Protein-fiber food supplement Before Meals
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.
干预措施: Food order nutritional intervention before meals (Dietary Supplement)
Protein-fiber food supplement after meals
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.
干预措施: Food order nutritional intervention after meals (Dietary Supplement)
结局指标
主要结局
Number of participants who completed OGTT during the first year postpartum
时间窗: Up to 1 year and 3 months
次要结局
- Number of participants who accept OGTT screening for GDM during enrollment(Within 3 months of enrollment)
- 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 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)
- 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 amplitude of glycemic excursions(Periprocedural)
- Time in normal glucose range(Periprocedural)
- Acceptability of the nutrition intervention(After postpartum follow-up for a period of 3 months)
- Feasibility of the nutrition intervention(After postpartum follow-up for a period of 3 months)