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Lifestyle interventions had no statistically significant difference in reducing worsening glycemic status compared to usual care in women with gestational diabetes.
Lifestyle interventions did not prevent glycemic deterioration among women in South Asia with recent gestational diabetes melitus (GDM), according to new findings.
Data show lifestyle interventions had no statistically significant difference in reducing worsening glycemic status (hazard ratio [HR], 0.92; 95% CI, 0.76 - 1.12; P = .42) in the GDM population.
“Compared with usual care, the intervention did not influence changes in body weight, fasting plasma glucose, or other outcomes,” wrote study author Nikhil Tandon, PhD, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences.
The population was constructed from the Lifestyle Intervention in Gestational Diabetes (LIVING) study, in which outcomes of a 12-month lifestyle intervention were compared to usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh.
Participants were women diagnosed with GDM within the previous 18 months with an oral glucose tolerance test (OGTT) from 24 - 34 weeks’ gestation. Potential participants had an OGTT from 3 months to 18 months postpartum, while exclusions included type 2 diabetes at OGTT and a travel time to the hospital of more than 2 hours.
The 12-month lifestyle interventions focused on diet and physical activity in both group and individual sessions, while also including remote engagement. Primary outcomes were defined as a deterioration in glycemia, consisting of a development of type 2 diabetes or progression from normal glucose tolerance (NGT) to prediabetes (impaired fasting glucose [IFG] or impaired glucose tolerance [IGT]).
Then, the primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, occuring at varying times after 12 months for each patient.
The study included a total of 1823 individuals who had an OGTT at a median of 6.5 months postpartum. From this number, 160 individuals (8.8%) had type 2 diabetes, 2 women (0.1%) met other exclusion criteria, and 49 women (2.7%) did not consent or were uncontactable.
As a result, 1612 women were randomized between November 2017 - January 2020 and following subsequent ineligibilities, 800 women were randomized to the intervention group and 801 women were randomized to usual care.
Participants had a mean age of 30.9 years and mean BMI of 26.6, while 600 women (37.5%) had prediabetes and 1001 women (62.5%) had normoglycemia. Among those randomized to the intervention, 644 women (80.5%) received all program content, but COVID-19 lockdowns affected the intervention delivery method.
At a median of 14.1 months of follow-up, a total of 1308 participants (81.7%) had an end-of-study follow-up OGTT. The worsening of glycemic status occurred in 421 participants, including 204 individuals (25.5%) in the lifestyle intervention group and 217 individuals (27.1%) in the usual care group.
However, no statistically significant difference between randomized groups in any secondary outcomes were observed.
Investigators noted that among individuals with prediabetes at baseline, 20.3% developed type 2 diabetes during follow-up compared to 3.2% among those with baseline normoglycemia.
“Given such high levels of risk, study outcomes suggest a compelling need to further investigate approaches to prevention, including pharmacotherapy,” investigators concluded.
The study, “Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes,” was published in JAMA Network Open.