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

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^*, 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

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-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 language	English
Journal	The Journal of clinical endocrinology and metabolism
ISSN	0021-972X
DOIs	https://doi.org/10.1210/clinem/dgae856
Publication status	E-pub / Early view - 9 Dec 2024

Keywords

gestational diabetes mellitus
diabetes prevention
family intervention
health promotion
randomized controlled trial

Access to Document

10.1210/clinem/dgae856

Face-IT
Maindal, H. T. (Project manager), Burau, V. (Participant) & Jensen, N. H. (Participant)
01/01/2018 → 31/12/2022
Project: Research

Cite this

Kragelund Nielsen, K., Dahl-Petersen, I. K., Jensen, D. M., Damm, P., Ovesen, P., Mathiesen, E. R., Kampmann, U., Vinter, C. A., Knorr, S., Andersen, L. L., Davidsen, E., Jensen, N. H., Aalders, J., Thøgersen, M., Timm, A., Støvring, H., & Maindal, H. T. (2024). Effectiveness of a family-based health promotion intervention for women with prior GDM: The Face-it RCT. The Journal of clinical endocrinology and metabolism. Advance online publication. https://doi.org/10.1210/clinem/dgae856

@article{9843056b7e6a4f288cea277028cadac8,

title = "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.",

keywords = "gestational diabetes mellitus, diabetes prevention, family intervention, health promotion, randomized controlled trial",

author = "{Kragelund Nielsen}, Karoline and Dahl-Petersen, {Inger Katrine} and Jensen, {Dorte M{\o}ller} and Peter Damm and Per Ovesen and Mathiesen, {Elisabeth R} and Ulla Kampmann and Vinter, {Christina Anne} and Sine Knorr and Andersen, {Lise Lotte} and Emma Davidsen and Jensen, {Nanna Husted} and Jori Aalders and Maja Th{\o}gersen and Anne Timm and Henrik St{\o}vring and Maindal, {Helle Terkildsen}",

note = "{\textcopyright} The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.",

year = "2024",

month = dec,

day = "9",

doi = "10.1210/clinem/dgae856",

language = "English",

journal = "The Journal of clinical endocrinology and metabolism",

issn = "0021-972X",

publisher = "Endocrine Society",

}

Kragelund Nielsen, K, Dahl-Petersen, IK, Jensen, DM, Damm, P, Ovesen, P, Mathiesen, ER, Kampmann, U, Vinter, CA, Knorr, S, Andersen, LL, Davidsen, E, Jensen, NH, Aalders, J, Thøgersen, M, Timm, A, Støvring, H & Maindal, HT 2024, 'Effectiveness of a family-based health promotion intervention for women with prior GDM: The Face-it RCT', The Journal of clinical endocrinology and metabolism. https://doi.org/10.1210/clinem/dgae856

Effectiveness of a family-based health promotion intervention for women with prior GDM: The Face-it RCT. / Kragelund Nielsen, Karoline; Dahl-Petersen, Inger Katrine; Jensen, Dorte Møller et al.
In: The Journal of clinical endocrinology and metabolism, 09.12.2024.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Effectiveness of a family-based health promotion intervention for women with prior GDM

T2 - The Face-it RCT

AU - Kragelund Nielsen, Karoline

AU - Dahl-Petersen, Inger Katrine

AU - Jensen, Dorte Møller

AU - Damm, Peter

AU - Ovesen, Per

AU - Mathiesen, Elisabeth R

AU - Kampmann, Ulla

AU - Vinter, Christina Anne

AU - Knorr, Sine

AU - Andersen, Lise Lotte

AU - Davidsen, Emma

AU - Jensen, Nanna Husted

AU - Aalders, Jori

AU - Thøgersen, Maja

AU - Timm, Anne

AU - Støvring, Henrik

AU - Maindal, Helle Terkildsen

PY - 2024/12/9

Y1 - 2024/12/9

N2 - 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.

AB - 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.

KW - gestational diabetes mellitus

KW - diabetes prevention

KW - family intervention

KW - health promotion

KW - randomized controlled trial

U2 - 10.1210/clinem/dgae856

DO - 10.1210/clinem/dgae856

M3 - Journal article

C2 - 39657967

SN - 0021-972X

JO - The Journal of clinical endocrinology and metabolism

JF - The Journal of clinical endocrinology and metabolism

ER -

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

Abstract

Keywords

Access to Document

Fingerprint

Projects

Face-IT

Cite this