Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Jul 15;110(8):e2456-e2470.
doi: 10.1210/clinem/dgae856.

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

Karoline Kragelund Nielsen  1 , Inger Katrine Dahl-Petersen  1 , Dorte Møller Jensen  2   3   4 , Peter Damm  5   6 , Per Ovesen  7   8   9 , Elisabeth R Mathiesen  6   10 , Ulla Kampmann  7   8 , Christina Anne Vinter  2   3   4 , Sine Knorr  7   8 , Lise Lotte Andersen  3 , Emma Davidsen  1   11 , Nanna Husted Jensen  11 , Jori Aalders  2   4 , Maja Thøgersen  1   11 , Anne Timm  1 , Henrik Støvring  7   12 , Helle Terkildsen Maindal  1   11
Affiliations
Randomized Controlled Trial

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

Karoline Kragelund Nielsen et al. J Clin Endocrinol Metab. .

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 (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.

Keywords: diabetes prevention; family intervention; gestational diabetes mellitus; health promotion; randomized controlled trial.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Study flowchart.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393‐403. - PMC - PubMed
    1. Tuomilehto J, Lindstrom J, Eriksson JG, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344(18):1343‐1350. - PubMed
    1. Ratner RE, Christophi CA, Metzger BE, et al. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008;93(12):4774‐4779. - PMC - PubMed
    1. Song C, Lyu Y, Li C, et al. Long-term risk of diabetes in women at varying durations after gestational diabetes: a systematic review and meta-analysis with more than 2 million women. Obes Rev. 2018;19(3):421‐429. - PubMed
    1. Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B. A systematic review of real-world diabetes prevention programs: learnings from the last 15 years. Implement Sci. 2015;10(1):172. - PMC - PubMed

Publication types