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

March 8, 2026 updated by: Elaine Quah, KK Women's and Children's Hospital

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:

  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 229899
        • Recruiting
        • KK Women's and Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kok Hian Tan, MD
        • Sub-Investigator:
          • Phaik Ling Quah, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: e-IMPACT Group
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
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.
No Intervention: Standard Care Group
Participants will receive standard antenatal care, an educational leaflet on physical activity during pregnancy, and a wearable tracker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
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).
At 24 weeks from baseline (from 31 to 35 weeks gestation)

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: 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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess participants' self-efficacy beliefs related to engaging in exercise during pregnancy at baseline (between 7 to 11 weeks gestation)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
At 24 weeks from baseline ( between 31 to 35 weeks gestation)
Assessing sleep quality at baseline ( between 7 to 11 weeks gestation)
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.
At baseline (between 7 to 11 weeks gestation)
Assessing sleep quality at 12 weeks from baseline (between 19 to 23 weeks gestation)
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.
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)
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.
At 24 weeks from baseline (between 31 to 35 weeks gestation)
Assessing mental health at 12 weeks from baseline (between19 to 23 weeks gestation)
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.
At 12 weeks from baseline ( between19 to 23 weeks gestation)
Assessing quality of life at baseline (between 7 to 11 weeks gestation)
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.
At baseline (between 7 to 11 weeks gestation)
Assessing quality of life at 12 weeks from baseline (between19 to 23 weeks gestation)
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.
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)
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.
At 24 weeks from baseline (between 31 to 35 weeks gestation)
Assessing gestational weight gain
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
At baseline and at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Collaborators

National University of Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECOS Ref No.: 2025-1379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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