KK Women's and Children's Hospital
Singapore, 229899
Location status: Recruiting
Location contact
KK WAC Hospital, MD
CONTACT
Kok Hian Tan, MD
PRINCIPAL_INVESTIGATOR
Phaik Ling Quah, PhD
CONTACT
Phaik Ling Quah, PhD
SUB_INVESTIGATOR
NCT Number: NCT07466797
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.
Interested in participating?
Request Info21 year–45 year
Female
Interventional
Not applicable
Singapore, 229899
Location status: Recruiting
KK WAC Hospital, MD
CONTACT
Kok Hian Tan, MD
PRINCIPAL_INVESTIGATOR
Phaik Ling Quah, PhD
CONTACT
Phaik Ling Quah, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: 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).
Time frame: At 24 weeks from baseline (between 31 to 35 weeks gestation)
Survey for only participants in the intervention group.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and at delivery
Gestational weight at baseline will be recorded and subtracted from final gestational weight before delivery from medical records
Contact information is provided by the study sponsor or research team.
Kok Hian Tan, M.D.
CONTACT
Quah Phaik Ling Quah, PhD
CONTACT
KK Women's and Children's Hospital
Other Gov
e-IMPACT: Evaluating an eHealth and Healthcare Professional Support Program to Promote Physical Activity During Pregnancy
Acronym: e-IMPACT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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