An interventional study of e-IMPACT programme in Physical Activity and Health Behavior, sponsored by KK Women's and Children's Hospital. Recruiting at 1 site in Singapore. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Prevention
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. The investigators 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.
967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 824 interventional studies indexed under Health Behavior.
Browse Health Behavior studies →KK Women's and Children's Hospital is the lead sponsor of 137 studies on the registry; 33 are open to participants now.
Compared within Health Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: e-IMPACT programme
Participants will receive standard antenatal care, an educational leaflet on physical activity during pregnancy, and a wearable tracker.
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.
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).
Time frame: 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).
Time frame: At 24 weeks from baseline (from 31 to 35 weeks gestation)
Assessing the feasibility, acceptability, and scalability of the study programme at 24 weeks from baseline (between 31 to 35 weeks gestation)
Survey for only participants in the intervention group.
Time frame: At 24 weeks from baseline (between 31 to 35 weeks gestation)
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.
Time frame: At baseline ( between 7 to 11 weeks gestation)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At baseline and at delivery
Plan to share: No — 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.
Started Mar 2026 (actual). Primary completion is estimated for Aug 2028, 29 months after the start.
Of 567 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 29 months is above that.
Counting every sponsor, half of 585 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
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