NCT07153081

Brief Summary

The aim of this study is to examine the effect of walking exercise in postpartum women and to evaluate the weight management intervention by using step tracker. The following hypotheses will be tested:

  1. 1.The intervention in postpartum women would reduce the retention of weight gained during pregnancy and lower the risk factors of chronic disease.
  2. 2.Step tracker is an effective tool in encouraging the postpartum women to do more physical activity.
  3. 3.Higher physical activity is recommended for postpartum women for healthy weight lost.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2021

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

August 26, 2025

Last Update Submit

September 12, 2025

Conditions

Keywords

postpartumphysical activityweight changerandomised controlled trial

Outcome Measures

Primary Outcomes (2)

  • Weight change at the end of the intervention at 10 weeks postpartum

    Using measured weight in kgs

    At 8-12 weeks postpartum from baseline (4-8 weeks postpartum)

  • Weight change at the end of the intervention at 14 weeks postpartum

    Using measured weight in kgs

    At 12 to 16 weeks postpartum from baseline ( 4-8 weeks postpartum)

Secondary Outcomes (11)

  • Change in body mass index measures from baseline, 10 weeks postpartum and 14 weeks postpartum

    Baseline (4-8 weeks postpartum), 10 weeks postpartum ( 8-12 weeks postpartum) and 14 weeks postpartum (12-16 weeks postpartum)

  • Change in waist circumference measures from baseline, 10 weeks postpartum and 14 weeks postpartum

    Baseline (4-8 weeks postpartum), 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum)

  • Change in waist to hip ratio from baseline, 10 weeks and 14 weeks postpartum

    Baseline 6 weeks postpartum (4-8 weeks postpartum), 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks postpartum (12-16 weeks postpartum).

  • Change in body fat mass from baseline, 10 and 14 weeks postpartum

    Baseline, 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum)

  • Change in fasting lipid profile from baseline, 10 weeks and 14 weeks postpartum

    Baseline, 10 weeks (8-12 week postpartum) and 14 weeks (12-16 weeks postpartum)

  • +6 more secondary outcomes

Study Arms (2)

Actigraphy watch intervention

EXPERIMENTAL

All the participants in the intervention group received an Actigraphy watch to wear all the time except for swimming and showering. Walking advises and motivational text messages will be sent to the study participants by the research team.

Device: Actigraphy watch intervention

Standard care group

NO INTERVENTION

Walking advises and motivational text messages will be sent to the study participants by the research team.

Interventions

Participants in this group only will be given an Actigraphy watch to track their physical activity levels.

Actigraphy watch intervention

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 21 years old
  • Viable singleton pregnancies
  • Physically fit to participate in moderate intensity walking.
  • Term pregnancy without any sever pregnancy complications. -

You may not qualify if:

  • \. Blood-borne disease patients (e.g. HIV, hepatitis B \& C) 2. Participated in other weight management or physical activity intervention projects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (2)

  • Maturi MS, Afshary P, Abedi P. Effect of physical activity intervention based on a pedometer on physical activity level and anthropometric measures after childbirth: a randomized controlled trial. BMC Pregnancy Childbirth. 2011 Dec 16;11:103. doi: 10.1186/1471-2393-11-103.

    PMID: 22176722BACKGROUND
  • Davenport MH, Giroux I, Sopper MM, Mottola MF. Postpartum exercise regardless of intensity improves chronic disease risk factors. Med Sci Sports Exerc. 2011 Jun;43(6):951-8. doi: 10.1249/MSS.0b013e3182051155.

    PMID: 21085038BACKGROUND

MeSH Terms

Conditions

Body Weight ChangesMotor Activity

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Bernard Su Min Chern, MD

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized, single-center, unblinded intervention study with a 1:! allocation ratio.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head & Senior Consultant

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 3, 2025

Study Start

October 20, 2020

Primary Completion

September 12, 2021

Study Completion

September 12, 2021

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The IPD will not be shared due to privacy concerns and the potential risk of re-identification, especially in a small sample size or a highly specific population

Locations