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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-IMPACT Group | Experimental | Participants will receive standard antenatal care, an educational leaflet on physical activity during pregnancy, and a wearable tracker. Participants will also receive the e-IMPACT programme. |
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| Standard Care Group | No Intervention | Participants will receive standard antenatal care, an educational leaflet on physical activity during pregnancy, and a wearable tracker. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-IMPACT programme | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of meeting physical activity guidelines at 12 weeks from baseline (between 19 to 23 weeks gestational age) | Objective measures of steps, moderate-to-vigorous physical activity and activity duration and energy expenditure (AEE) will be assessed using an activity tracker to capture physical activity engagement, sedentary time and energy expenditure (MET-min/day). | 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) | Objective measures of steps, moderate-to-vigorous physical activity and activity duration and energy expenditure (AEE) will be assessed using an activity tracker to capture physical activity engagement, sedentary time and energy expenditure (MET-min/day). | At 24 weeks from baseline (from 31 to 35 weeks gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the feasibility, acceptability, and scalability of the e-IMPACT programme at 24 weeks from baseline (between 31 to 35 weeks gestation) | Survey for only participants in the intervention group. | At 24 weeks from baseline (between 31 to 35 weeks gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| Assess participants' self-efficacy beliefs related to engaging in exercise during pregnancy at baseline (between 7 to 11 weeks gestation) | Using the validated Pregnancy Exercise Self- Efficacy Scale. Total scores range from 10 to 50, with higher scores indicating greater exercise self-efficacy during pregnancy. | At baseline ( between 7 to 11 weeks gestation) |
Inclusion Criteria:
Exclusion Criteria:
Only participants who self-identify as women and are currently pregnant are eligible to participate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quah Phaik Ling Quah, PhD | Contact | +6597732543 | quah.phaik.ling@kkh.com.sg | |
| Kok Hian Tan, M.D. | Contact | +65 6394 1099 | tan.kok.hian@singhealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Recruiting | Singapore | 229899 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36695278 | Background | 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. | |
| 26140834 | Background | 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. |
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Individual participant data (IPD) will not be shared due to the sensitive nature of the dataset, which involves pregnant participants and potentially identifiable health and obstetric information.
Although all data will be de-identified, there remains a risk of participant re-identification given the small sample size and the unique combination of demographic and pregnancy-related variables.
Furthermore, consent for open data sharing was not obtained from participants, and sharing IPD beyond the study team would therefore not comply with the approved ethics protocol.
Aggregated results and summary statistics will be shared through publications and conference presentations, in accordance with ethical approval and data protection regulations.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Participants randomized to both the control and the intervention group
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| Assess participants' self-efficacy beliefs related to engaging in exercise during pregnancy at 12 weeks from baseline (between19 to 23 weeks gestation) | Using the validated Pregnancy Exercise Self- Efficacy Scale. Total scores range from 10 to 50, with higher scores indicating greater exercise self-efficacy during pregnancy. | At 12 weeks from baseline (between19 to 23 weeks gestation) |
| Assess participants' self-efficacy beliefs related to engaging in exercise during pregnancy at 24 weeks from baseline (between 31 to 35 weeks gestation) | Using the validated Pregnancy Exercise Self- Efficacy Scale. Total scores range from 10 to 50, with higher scores indicating greater exercise self-efficacy during pregnancy. | At 24 weeks from baseline (between 31 to 35 weeks gestation) |
| Assess participants' self- motivation related to engaging in exercise during pregnancy at baseline (between 7 to 11 weeks gestation) | Using validated Behavioural Regulation in Exercise Questionnaire (BREQ-2). Scores range from 0 to 4 for each subscale, with higher scores reflecting stronger endorsement of that type of exercise motivation. | At baseline ( between 7 to 11 weeks gestation) |
| Assess participants' self- motivation related to engaging in exercise during pregnancy at 12 weeks from baseline (between19 to 23 weeks gestation) | Using validated Behavioural Regulation in Exercise Questionnaire (BREQ-2). Scores range from 0 to 4 for each subscale, with higher scores reflecting stronger endorsement of that type of exercise motivation. | At 12 weeks from baseline (between19 to 23 weeks gestation) |
| Assess participants' self- motivation related to engaging in exercise during pregnancy at 24 weeks from baseline ( between 31 to 35 weeks gestation) | Using validated Behavioural Regulation in Exercise Questionnaire (BREQ-2). Scores range from 0 to 4 for each subscale, with higher scores reflecting stronger endorsement of that type of exercise motivation. | At 24 weeks from baseline ( between 31 to 35 weeks gestation) |
| Assessing sleep quality at baseline ( between 7 to 11 weeks gestation) | Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire. Global scores range from 0 to 21, with higher scores indicating worse sleep quality; scores greater than 5 suggest poor sleep. | At baseline (between 7 to 11 weeks gestation) |
| Assessing sleep quality at 12 weeks from baseline (between 19 to 23 weeks gestation) | Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire. Global scores range from 0 to 21, with higher scores indicating worse sleep quality; scores greater than 5 suggest poor sleep. | At 12 weeks from baseline (between 19 to 23 weeks gestation) |
| Assessing sleep quality at 24 weeks from baseline (between 31 to 35 weeks gestation) | Using the Pittsburgh Sleep Quality Index (PSQI) Questionnaire. Global scores range from 0 to 21, with higher scores indicating worse sleep quality; scores greater than 5 suggest poor sleep. | At 24 weeks from baseline (between 31 to 35 weeks gestation) |
| Assessing mental health at 12 weeks from baseline (between19 to 23 weeks gestation) | Using the Edinburgh Postnatal Depression Scale (EPDS). Total scores range from 0 to 30, with higher scores indicating greater depressive symptom severity; scores ≥13 suggest probable depression. | At 12 weeks from baseline ( between19 to 23 weeks gestation) |
| Assessing quality of life at baseline (between 7 to 11 weeks gestation) | Using the EuroQol-5 Dimension (EQ-5D). The scores ranges from 0 to 100, with higher scores reflecting better self-rated health. | At baseline (between 7 to 11 weeks gestation) |
| Assessing quality of life at 12 weeks from baseline (between19 to 23 weeks gestation) | Using the EuroQol-5 Dimension (EQ-5D). The scores ranges from 0 to 100, with higher scores reflecting better self-rated health. | At 12 weeks from baseline (between19 to 23 weeks gestation) |
| Assessing quality of life at 24 weeks from baseline ( between 31 to 35 weeks gestation) | Using the EuroQol-5 Dimension (EQ-5D). The scores ranges from 0 to 100, with higher scores reflecting better self-rated health. | At 24 weeks from baseline (between 31 to 35 weeks gestation) |
| Assessing gestational weight gain | Gestational weight at baseline will be recorded and subtracted from final gestational weight before delivery from medical records | At baseline and at delivery |
| 35325689 | Background | 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. |
| 31409285 | Background | 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. |
| 31126153 | Background | 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. |
| 36457104 | Background | 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. |