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

Karoline Kragelund Nielsen, Inger Katrine Dahl-Petersen, Dorte Møller Jensen, Peter Damm, Per Ovesen, Elisabeth R Mathiesen, Ulla Kampmann, Christina Anne Vinter, Sine Knorr, Lise Lotte Andersen, Emma Davidsen, Nanna Husted Jensen, Jori Aalders, Maja Thøgersen, Anne Timm, Henrik Støvring, Helle Terkildsen Maindal

Research output: Contribution to journalJournal articleResearchpeer-review

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.

Original languageEnglish
JournalThe Journal of clinical endocrinology and metabolism
ISSN0021-972X
DOIs
Publication statusE-pub ahead of print - 9. Dec 2024

Bibliographical note

© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.

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