NCT07466797

Brief 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. 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. 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. 3.with enhanced self-efficacy and motivation, the proportion of women engaging in adequate physical activity during pregnancy will increase to meet recommended guidelines.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

February 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

February 1, 2026

Last Update Submit

March 8, 2026

Conditions

Physical ActivityHealth Behavior

Keywords

pregnancyexercise in pregnancyphysical activity in pregnancy

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (1)

  • Assessing the feasibility, acceptability, and scalability of the e-IMPACT programme at 24 weeks from baseline (between 31 to 35 weeks gestation)

    At 24 weeks from baseline (between 31 to 35 weeks gestation)

Other Outcomes (14)

  • Assess participants' self-efficacy beliefs related to engaging in exercise during pregnancy at baseline (between 7 to 11 weeks gestation)

    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)

    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)

    At 24 weeks from baseline (between 31 to 35 weeks gestation)

  • +11 more other outcomes

Study Arms (2)

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.

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.

Interventions

e-IMPACT programmeBEHAVIORAL

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.

e-IMPACT Group

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly participants who self-identify as women and are currently pregnant are eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

Related Publications (6)

  • 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.

    PMID: 36695278BACKGROUND

  • 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.

    PMID: 26140834BACKGROUND

  • 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.

    PMID: 35325689BACKGROUND

  • 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.

    PMID: 31409285BACKGROUND

  • 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.

    PMID: 31126153BACKGROUND

  • 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.

    PMID: 36457104BACKGROUND

MeSH Terms

Conditions

Motor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Quah Phaik Ling Quah, PhD

CONTACT

+6597732543quah.phaik.ling@kkh.com.sg

Kok Hian Tan, M.D.

CONTACT

+65 6394 1099tan.kok.hian@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants randomized to both the control and the intervention group
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 1, 2026

First Posted

March 12, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

SG(1)