Physical Activitye-IMPACTNCT07466797
The eHealth Integrated Maternal Physical Activity Programme in Prenatal Care Trial (E-IMPACT)
A study testing e-IMPACT programme in people with Physical Activity and Health Behavior, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Behavior
- What is being tested?
- e-IMPACT programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
KK WAC Hospital, MD, 97732543, tan.kok.hian@singhealth.com.sg
Phaik Ling Quah, PhD, 97732543, quah.phaik.ling@kkh.com.sg
About this study
Official title: e-IMPACT: Evaluating an eHealth and Healthcare Professional Support Program to Promote Physical Activity During Pregnancy
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:
- 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
- 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
- with enhanced self-efficacy and motivation, the proportion of women engaging in adequate physical activity during pregnancy will increase to meet recommended guidelines.
Read the detailed description
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.
- Conditions
- Physical Activity, Health Behavior
- Being tested
- e-IMPACT programme
- Keywords
- pregnancy, exercise in pregnancy, physical activity in pregnancy
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-IMPACT programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: e-IMPACT programme |
| Standard Care Group | No intervention | Participants will receive standard antenatal care, an educational leaflet on physical activity during pregnancy, and a wearable tracker. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: At 24 weeks from baseline (from 31 to 35 weeks gestation)
Secondary outcomes (1)
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.
Measured: At 24 weeks from baseline (between 31 to 35 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start9 Mar 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to both the control and the intervention group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Elaine Quah, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466797
- Sponsor's protocol ID
- ECOS Ref No.: 2025-1379
- Acronym
- e-IMPACT
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 36695278Padmapriya 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.
PubMed 26140834He 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.
PubMed 35325689He 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.
PubMed 31409285Chan 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.
PubMed 31126153Sharp 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.
PubMed 36457104
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-IMPACT: Evaluating an eHealth and Healthcare Professional Support Program to Promote Physical Activity During Pregnancy
- ClinicalTrials.gov ID
- NCT07466797
- Acronym / sponsor ID
- e-IMPACT / ECOS Ref No.: 2025-1379
- Conditions
- Physical Activity, Health Behavior
- Keywords
- pregnancy, exercise in pregnancy, physical activity in pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- National University of Singapore
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- with enhanced self-efficacy and motivation, the proportion of women engaging in adequate physical activity during pregnancy will increase to meet recommended guidelines.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomized to both the control and the intervention group
| Arm | Type | Receives |
|---|---|---|
| e-IMPACT Group | Experimental | Behavioral: e-IMPACT programmeParticipants 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. |
| Standard Care Group | No intervention | –Participants will receive standard antenatal care, an educational leaflet on physical activity during pregnancy, and a wearable tracker. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-IMPACT programmea 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. | Behavioural | e-IMPACT Group |
Primary outcome
Assessment of meeting physical activity guidelines at 12 weeks from baseline (between 19 to 23 weeks gestational age)
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).
Assessment of meeting physical activity guidelines at 24 weeks from baseline (from 31 to 35 weeks gestation)
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).
1 secondary outcome
Assessing the feasibility, acceptability, and scalability of the study programme at 24 weeks from baseline (between 31 to 35 weeks gestation)
Time frame: At 24 weeks from baseline (between 31 to 35 weeks gestation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 36695278Tan 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.
- Background: PubMed 26140834Padmapriya 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.
- Background: PubMed 35325689He 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.
- Background: PubMed 31409285He 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.
- Background: PubMed 31126153Chan 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.
- Background: PubMed 36457104Sharp 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-IMPACT programme in people with Physical Activity and Health Behavior, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quah Phaik Ling Quah, PhD (+6597732543, quah.phaik.ling@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of meeting physical activity guidelines at 12 weeks from baseline (between 19 to 23 weeks gestational age) (time frame: At 12 weeks from baseline (between 19 to 23 weeks gestational age)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466797, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.