Effectiveness of a Family-based Health Promotion Intervention for Women With Prior GDM: The Face-It RCT.

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 (1) home visits with tailored family-based counseling (2) digital health coaching, and (3) structured cross-sectoral communication.

Main outcome measures: Primary outcomes were body mass index (BMI) and quality of life [12-Item Short-Form mental component score (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% confidence interval (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 prespecified post hoc analysis demonstrated a reduced BMI in the intervention group among women with BMI ≥25 kg/m2 (-0.86 kg/m2; 95% CI -1.58 to -0.14).Analyses of secondary and tertiary outcomes indicated significantly lower 2-hour 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 (odds ratio 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.