Trials · 2026
Lifestyle intervention to prevent postpartum type 2 diabetes in Asian women with recent gestational diabetes and normal post-pregnancy glucose tolerance: study protocol for a randomized controlled trial with a targeted postpartum lifestyle programme.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Quah Phaik Ling, Song He, Han Wee Meng, Lim Ethel Jie Kai, Bakar Muhammad Alif Abu, Fadzully Fadzlynn, Tan Lay Kok, Suzanna Sulaiman, Eriksson Johan Gunnar, Chan Shiao-Yng, Finkelstein Eric Andrew, Tan Kok Hian
Аннотация
BACKGROUND: The primary aim of the Integrated Hyperglycaemia Incentivized Postnatal Surveillance (IHIPS) study is to reduce the incidence of type 2 diabetes mellitus (T2DM) among women with a history of gestational diabetes mellitus (GDM) in their index pregnancy who demonstrate normal glucose tolerance in the early postpartum period. This is being evaluated through a single-centre randomized controlled trial (RCT) conducted at KK Women's and Children's Hospital (KKH) in Singapore.
METHODS: The study aims to recruit 200 women between 8 and 12 weeks postpartum. The primary objective is to assess the cumulative incidence of T2DM over a 36-month follow-up period. Secondary objectives include evaluating the incidence of dysglycaemia (prediabetes and T2DM) at 12-, 24-, and 36-month follow-ups, as well as monitoring longitudinal changes in cardiometabolic risk factors, physical activity, and dietary intake from 6 to 36 months. Cost-effectiveness will also be assessed. Participants in the intervention group will receive a multi-component programme that includes personalized goal-setting workshops supported by wearable technologies, such as continuous glucose monitors and Fitbit trackers. The control group will receive standard postnatal care. All participants will provide blood samples and undergo anthropometric and body composition measurements. Participants will also complete self-administered questionnaires evaluating dietary intake, physical activity, health-related quality of life, and their experience with the clinical trial.
DISCUSSION: The IHIPS study is expected to provide insights to guide the development of early postpartum, hospital-based lifestyle interventions, with the potential to improve long-term health outcomes for mothers and their infants.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05081037 . Registered on 06 September 2021, https://clinicaltrials.gov/study/NCT05081037 .
METHODS: The study aims to recruit 200 women between 8 and 12 weeks postpartum. The primary objective is to assess the cumulative incidence of T2DM over a 36-month follow-up period. Secondary objectives include evaluating the incidence of dysglycaemia (prediabetes and T2DM) at 12-, 24-, and 36-month follow-ups, as well as monitoring longitudinal changes in cardiometabolic risk factors, physical activity, and dietary intake from 6 to 36 months. Cost-effectiveness will also be assessed. Participants in the intervention group will receive a multi-component programme that includes personalized goal-setting workshops supported by wearable technologies, such as continuous glucose monitors and Fitbit trackers. The control group will receive standard postnatal care. All participants will provide blood samples and undergo anthropometric and body composition measurements. Participants will also complete self-administered questionnaires evaluating dietary intake, physical activity, health-related quality of life, and their experience with the clinical trial.
DISCUSSION: The IHIPS study is expected to provide insights to guide the development of early postpartum, hospital-based lifestyle interventions, with the potential to improve long-term health outcomes for mothers and their infants.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05081037 . Registered on 06 September 2021, https://clinicaltrials.gov/study/NCT05081037 .