The eHealth Integrated Maternal Physical Activity Programme in Prenatal Care Trial (E-IMPACT)

Официальное название

e-IMPACT: Evaluating an eHealth and Healthcare Professional Support Program to Promote Physical Activity During Pregnancy

Обзор

This will be a proof-of-concept randomised control trial (RCT) study, where 100 pregnant women will be recruited in the first trimester of pregnancy and followed-up until delivery. It aims to test these following hypotheses: 1. pregnancy is a window of opportunity to implement good lifestyle habits of physical activity and exercise as pregnant women are in regular contact with health professionals and are likely motivated and be more confident to carry out these activities according to the guidelines 2. this integrated programme will effective in a healthcare setting, and will bring Singapore's "Guidelines on Physical Activity and Exercise in Pregnancy" guidelines to implementation 3. with enhanced self-efficacy and motivation, the proportion of women engaging in adequate physical activity during pregnancy will increase to meet recommended guidelines.

Подробное описание

In Singapore, where national initiatives such as Healthier SG aim to promote active lifestyles, nearly one-third of pregnant women are affected by overweight or obesity (BMI ≥ 23 kg/m²), increasing health risks for both mother and child. These women are typically less physically active than their lean counterparts, a gap that often widens during pregnancy, leading to excessive gestational weight gain and postpartum weight retention that heighten long-term metabolic and cardiovascular risks. Culturally tailored, region-specific strategies are needed to support healthy behaviours during pregnancy. We propose an integrated eHealth prenatal programme offering personalised guidance, credible information, and improved communication with healthcare professionals to overcome existing barriers and promote sustained physical activity-a critical yet under-addressed priority in Asia.

This will be a proof-of-concept randomised control trial (RCT) study, where 100 pregnant overweight/obese women (BMI 23 kg/m2 or above) will be recruited from KK Women's and Children's hospital in the first trimester of pregnancy with consent form completion after meeting the inclusion criteria. After the first baseline visit, all participants will be followed-up in the second and third trimester of the pregnancy.

All participants recruited will be randomised into one of two groups through block-randomization of size 2 to reduce bias and achieve balance in the allocation of participants to intervention arms. All participants will receive standard routine antenatal care, along with an educational leaflet on physical activity and exercise during pregnancy and a wearable tracker. The intervention group will receive the e-IMPACT programme in three parts led by exercise physiologist from the Singapore Sport and Exercise Medicine Centre @ KKH in the first, second and third trimester of pregnancy.

This study will evaluate behavioural, psychological, and health-related outcomes among pregnant participants. Physical activity will be objectively measured using a Fitbit tracker to record steps, activity duration, moderate-to-vigorous physical activity, and energy expenditure, and subjectively using the Pregnancy Physical Activity Questionnaire (PPAQ) to assess self-reported activity, sedentary time, and energy expenditure (MET-min/day). Participants' self-efficacy and motivation to engage in exercise during pregnancy will be assessed at baseline and post-intervention using the Pregnancy Exercise Self-Efficacy Scale (P-ESES) and the Behavioural Regulation in Exercise Questionnaire (BREQ-2). Feasibility, acceptability, and scalability of the e-IMPACT programme will be evaluated through a process evaluation guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, incorporating feedback from both participants and exercise physiologists. Exploratory outcomes will include sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), antenatal anxiety and depression measured by the Edinburgh Postnatal Depression Scale (EPDS), and health-related quality of life measured by the EuroQol-5 Dimension (EQ-5D). Gestational weight gain will be determined from medical records, using the first and last recorded gestational weights.

Вмешательства

• Поведенческое e-IMPACT programme
  a three-part prenatal physical activity intervention delivered across all trimesters. It includes telehealth one-on-one consultations using Motivational Interviewing and SMART goal-setting, wearable trackers for self-monitoring, and guideline-based educational content via pre-recorded digital videos.

Первичные конечные точки

• Assessment of meeting physical activity guidelines at 12 weeks from baseline (between 19 to 23 weeks gestational age) [Срок оценки: At 12 weeks from baseline (between 19 to 23 weeks gestational age)]
• Assessment of meeting physical activity guidelines at 24 weeks from baseline (from 31 to 35 weeks gestation) [Срок оценки: At 24 weeks from baseline (from 31 to 35 weeks gestation)]

Вторичные конечные точки (1)

• Assessing the feasibility, acceptability, and scalability of the e-IMPACT programme at 24 weeks from baseline (between 31 to 35 weeks gestation) [Срок оценки: At 24 weeks from baseline (between 31 to 35 weeks gestation)]

Критерии участия

Критерии включения

• Pregnant women (First trimester at least 4 weeks gestation)
• Age 21 years and above
• BMI 23 kg/m2 and above
• Physically fit to participate in moderate intensity exercise
• Singleton pregnancy

Критерии исключения

• Women who have severe chronic disease such as chronic kidney disease, hypertension, asthma OR
• Obstetric or medical complications which might preclude women in normal levels of physical activity or exercise during pregnancy.
• Women who participated in other weight management programmes, or physical activity intervention studies recently (past 6 months) or concurrently
• Difficulty in understanding the English language

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Сингапур · 1 центр

• KK Women's and Children's Hospital — Singapore

Публикации

• Tan YR, Tan KH, Dai F, Tan HK, Tan LK. Attitudes and practices of exercise among pregnant mothers in Singapore. Singapore Med J. 2024 Sep 1;65(9):488-493. doi: 10.4103/singaporemedj.SMJ-2021-247. Epub 2023 Jan 6. PMID 36695278
• Padmapriya N, Shen L, Soh SE, Shen Z, Kwek K, Godfrey KM, Gluckman PD, Chong YS, Saw SM, Muller-Riemenschneider F. Physical Activity and Sedentary Behavior Patterns Before and During Pregnancy in a Multi-ethnic Sample of Asian Women in Singapore. Matern Child Health J. 2015 Nov;19(11):2523-35. doi: 10.1007/s10995-015-1773-3. PMID 26140834
• He S, Allen JC, Razali NS, Chern BSM, Tan KH. Association between gestational weight gain and pregnancy outcomes in a Singaporean population: A prospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2022 May;272:160-165. doi: 10.1016/j.ejogrb.2022.03.031. Epub 2022 Mar 17. PMID 35325689
• He S, Allen JC, Razali NS, Win NM, Zhang JJ, Ng MJ, Yeo GSH, Chern BSM, Tan KH. Are women in Singapore gaining weight appropriately during pregnancy: a prospective cohort study. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):290. doi: 10.1186/s12884-019-2443-z. PMID 31409285
• Chan CWH, Au Yeung E, Law BMH. Effectiveness of Physical Activity Interventions on Pregnancy-Related Outcomes among Pregnant Women: A Systematic Review. Int J Environ Res Public Health. 2019 May 23;16(10):1840. doi: 10.3390/ijerph16101840. PMID 31126153
• Sharp KJ, Sherar LB, Kettle VE, Sanders JP, Daley AJ. Effectiveness of interventions to increase device-measured physical activity in pregnant women: systematic review and meta-analysis of randomised controlled trials. Int J Behav Nutr Phys Act. 2022 Dec 1;19(1):142. doi: 10.1186/s12966-022-01379-w. PMID 36457104

Идентификаторы

NCT: NCT07466797 · ECOS Ref No.: 2025-1379

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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