A lifestyle intervention program failed to prevent deterioration in glycemic status in postpartum women who had gestational diabetes during pregnancy compared with those who received usual standard of care, according to the results of research published in JAMA Network Open.
Researchers conducted a randomized controlled trial between November 2017 and January 2020 with participant follow-up ending in January 2021 analyzing the efficacy of a 12-month lifestyle intervention program to prevent worsening glycemic status in 1601 normoglycemic (n=1001) or prediabetic (n=600) South Asian women between 3 to 18 months postpartum in 19 urban hospitals throughout India, Sri Lanka, and Bangladesh.
The investigators randomly assigned these women into 2 groups, with 800 women receiving the interventional treatment and 801 receiving usual standard of care. The planned 12-month interventional program consisted of group and individual sessions that addressed diet and physical activity, as well as remote engagement that involved prerecorded or text messages and telephone calls.
The primary outcome was worsening of glycemic status — defined as progression of normoglycemia to prediabetes and prediabetes to type 2 diabetes — as determined by oral glucose tolerance test (OGTT). Secondary outcomes included changes in fasting plasma glucose, body weight, waist circumference, systolic blood pressure, caloric intake, and physical activity levels.
After data analysis, 204 (25.5%) women in the interventional group exhibited worsening glycemic status, as did 217 (27.1%) women receiving standard of care, resulting in a lack of statistical significance (hazard ratio, 0.92; 95% CI, 0.76-1.12; P =.42) between the 2 groups. There were no significant changes in secondary outcomes between the 2 groups.
Limitations of the study included COVID-19 restrictions that affected program delivery and outcome assessment, unblinding of participants to the intervention, self-reporting on physical activity levels and diet potentially affected by reporting bias resulting in unreliable data, and location bias to urban hospitals.
“Most women who were assessed developed a deterioration of glycemia during the follow-up before or after randomization, and those with prediabetes represented a particularly high-risk group for the development of diabetes,” the authors said. “These findings suggest that additional strategies, including preventative drug therapies, should be considered for further research in this group.”
Disclosure: One author disclosed affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Tandon N, Gupta Y, Kapoor D, et al. Effects of a lifestyle intervention to prevent deterioration in glycemic status among South Asian women with recent gestational diabetes: a randomized clinical trial. JAMA Network Open. 2022;5(3):e220773. doi:10.1001/jamanetworkopen.2022.0773