Effectiveness of a family-based health promotion intervention for women with prior GDM: The Face-it RCT

Abstract Context Gestational diabetes mellitus (GDM) increases the risk of future type 2 diabetes (T2DM), but effective and feasible interventions to reduce this risk are lacking. Objective To evaluate the effectiveness of a family-based health promotion intervention on T2DM risk factors and quality of life among women with recent GDM. Design Multicenter, parallel, open-label randomized controlled trial with 2:1 allocation ratio. Setting Three sites in Denmark. Participants Women diagnosed with GDM. Intervention(s) The intervention consisted of (i) home visits with tailored family-based counseling (ii) digital health coaching, (iii) structured cross-sectoral communication. Main Outcome Measures Primary outcomes were body mass index (BMI) and quality of life (SF12 MCS) 1-year after delivery. Results We randomized 277 women to the intervention (n=184) or usual care group (n=93). The intervention did not result in significantly lower BMI (-0.44 kg/m2; 95%CI -0.98 to 0.11) or higher SF12 MCS (0.06; 95%CI -2.15 to 2.27) compared to the usual care group. A pre-specified post hoc analysis demonstrated a reduced BMI in the intervention group among women with BMI ≥25 kg/m2 (-0.86 kg/m2; (-1.58 to -0.14)). Analyses of secondary and tertiary outcomes indicated significantly lower 2-h insulin (-94.3 pmmol/L; 95%CI -167.9 to -20.6) and triglycerides (-0.18 mmol/L; 95%CI -0.30 to -0.05) levels, and odds of fasting plasma glucose ≥6·1 mmol/L (OR 0.33; 95%CI 0.12 to 0.91) in the intervention group. Conclusion The intervention did not result in lower BMI or increased quality of life, but seemingly reduced other risk factors, and lowered BMI in the subgroup of overweight women.