Weight ChangeNCT07153081
Wearable-Supported Exercise to Reduce Postpartum Weight
A study testing Actigraphy watch intervention in people with Weight Change, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Change
- What is being tested?
- Actigraphy watch intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Oct 2020to 12 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 21 years old
- Viable singleton pregnancies
- Physically fit to participate in moderate intensity walking.
- Term pregnancy without any sever pregnancy complications. -
Who cannot join
- 1. Blood-borne disease patients (e.g. HIV, hepatitis B \& C) 2. Participated in other weight management or physical activity intervention projects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Wearable-supported Exercise Interventions for Reducing Postpartum Weight: a Randomized Controlled Trial
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:
- The intervention in postpartum women would reduce the retention of weight gained during pregnancy and lower the risk factors of chronic disease.
- Step tracker is an effective tool in encouraging the postpartum women to do more physical activity.
- Higher physical activity is recommended for postpartum women for healthy weight lost.
Read the detailed description
Postpartum is an important phase in the reproductive years of women. Weight retention after childbirth can lead to chronic diseases (CD), including obesity, cardiovascular disease and other metabolic related diseases such as diabetes or high blood pressure. There are some studies suggesting that pedometer is useful to encourage women in increasing their physical activity.
We propose to evaluate the effects of physical activity intervention based on wearable steps tracker and optimal weight loss for postpartum women. It will be a pilot stratified randomized intervention study on 200 postpartum women at KK Women's and Children's Hospital. Women who are above 21 years old and had given birth between 6 weeks and 6 months before will be recruited under the study. Postpartum women who physically fit to participate in moderate intensity walking are eligible to participate in the study. Women who participated in other weight management or physical activity intervention projects will be excluded from the study. Study enrolment will be done at the Specialist Outpatient Clinics for postnatal check-ups.
This was 12-16 weeks randomized, single-center, unblinded intervention study (Figure 1). Participants were allocated in a 1:1 ratio to either the intervention group (Actigraphy watch) or the control group (no Actigraphy watch). All participants received the standard routine postpartum care, physical activity counselling with advice on walking and motivational messages. Randomization was done using sealed envelopes. Eligible participants had baseline measurements taken during the study enrolment and consent taking where anthropometric measurements, and blood samples were collected and various questionnaires were filled out to assess baseline demographics and lifestyle characteristics.
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.
Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, and self-reported physical activity. Bio-physical measurements will be obtained from anthropometric measurements of participants, are collected from the participants at their follow-up time points. Objective physical activity will be collected using an Actigraphy watch.
- Conditions
- Weight Change
- Being tested
- Actigraphy watch intervention
- Keywords
- postpartum, physical activity, weight change, randomised controlled trial
- Medical subject headings
- Body Weight Changes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actigraphy watch interventionDevice
Participants in this group only will be given an Actigraphy watch to track their physical activity levels.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change at the end of the intervention at 10 weeks postpartum
Using measured weight in kgs
Measured: 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
Measured: 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
Calculating body mass index (kg/m2) using height (m) and weight (kg) measures
Measured: 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
Using waist circumference measures in cm
Measured: 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
Using waist circumference and hip measures
Measured: 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
Using body fat mass percentage measured using the bioelectrical impedance analysis scale
Measured: 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
Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples in mmol/L
Measured: Baseline, 10 weeks (8-12 week postpartum) and 14 weeks (12-16 weeks postpartum)
Change in glucose homeostasis markers from baseline at 10 weeks and 14 weeks postpartum
Using fasting glucose and fasting insulin from blood samples in mmol/L
Measured: Baseline, 10 weeks (8-12 weeks postpartum), and 14 weeks (12-16 weeks postpartum)
Change in blood pressure from baseline at 10 weeks and 14 weeks postpartum
Using measured systolic and diastolic blood pressure in mm/Hg
Measured: At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum)
Change in self-reported frequency of moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks
Self-reported data from the International Physical Activity Questionnaire (IPAQ) to assess frequency of moderate to vigorous physical activity.
Measured: At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum).
Change in self-reported duration of moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks
Self-reported data from the International Physical Activity Questionnaire (IPAQ) to assess duration of moderate to vigorous physical activity..
Measured: At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum).
Change in duration of objective moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks
MVPA will be assessed using an Actigraphy accelerometer Duration: Average daily/weekly minutes of MVPA (minutes per week).
Measured: Baseline, 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks (12-16 weeks).
Change in frequency of objective moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks
MVPA will be assessed using an Actigraphy accelerometer Frequency: Number of days per week with ≥30 minutes of MVPA (days per week).
Measured: Baseline, 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks (12-16 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start20 Oct 2020
- Primary completion12 Sep 2021
- Study completion12 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weight ChangeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-center, unblinded intervention study with a 1:! allocation ratio.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bernard Chern Su Min, KK Women's and Children's Hospital
- Investigators
- Bernard Su Min Chern, MD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153081
- Sponsor's protocol ID
- CIRB: Ref No.: 2017/3015
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 22176722Davenport 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.
PubMed 21085038Quah PL, Tan KH, Tan MH, Chern BSM. Evaluating wearable-supported exercise interventions for reducing postpartum weight: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Apr 1;26(1):515. doi: 10.1186/s12884-026-08937-1.
PubMed 41917836
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Wearable-supported Exercise Interventions for Reducing Postpartum Weight: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07153081
- Acronym / sponsor ID
- CIRB: Ref No.: 2017/3015
- Conditions
- Weight Change
- Keywords
- postpartum, physical activity, weight change, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 12 Sep 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 3 Sep 2025 (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.
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:
- The intervention in postpartum women would reduce the retention of weight gained during pregnancy and lower the risk factors of chronic disease.
- Step tracker is an effective tool in encouraging the postpartum women to do more physical activity.
- Higher physical activity is recommended for postpartum women for healthy weight lost.
Detailed description
Postpartum is an important phase in the reproductive years of women. Weight retention after childbirth can lead to chronic diseases (CD), including obesity, cardiovascular disease and other metabolic related diseases such as diabetes or high blood pressure. There are some studies suggesting that pedometer is useful to encourage women in increasing their physical activity.
We propose to evaluate the effects of physical activity intervention based on wearable steps tracker and optimal weight loss for postpartum women. It will be a pilot stratified randomized intervention study on 200 postpartum women at KK Women's and Children's Hospital. Women who are above 21 years old and had given birth between 6 weeks and 6 months before will be recruited under the study. Postpartum women who physically fit to participate in moderate intensity walking are eligible to participate in the study. Women who participated in other weight management or physical activity intervention projects will be excluded from the study. Study enrolment will be done at the Specialist Outpatient Clinics for postnatal check-ups.
This was 12-16 weeks randomized, single-center, unblinded intervention study (Figure 1). Participants were allocated in a 1:1 ratio to either the intervention group (Actigraphy watch) or the control group (no Actigraphy watch). All participants received the standard routine postpartum care, physical activity counselling with advice on walking and motivational messages. Randomization was done using sealed envelopes. Eligible participants had baseline measurements taken during the study enrolment and consent taking where anthropometric measurements, and blood samples were collected and various questionnaires were filled out to assess baseline demographics and lifestyle characteristics.
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.
Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, and self-reported physical activity. Bio-physical measurements will be obtained from anthropometric measurements of participants, are collected from the participants at their follow-up time points. Objective physical activity will be collected using an Actigraphy watch.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, single-center, unblinded intervention study with a 1:! allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Actigraphy watch intervention | Experimental | Device: Actigraphy watch interventionAll 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. |
| Standard care group | No intervention | –Walking advises and motivational text messages will be sent to the study participants by the research team. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 21 years old
- Viable singleton pregnancies
- Physically fit to participate in moderate intensity walking.
- Term pregnancy without any sever pregnancy complications. -
Key exclusion criteria (1 listed)
- 1. Blood-borne disease patients (e.g. HIV, hepatitis B \& C) 2. Participated in other weight management or physical activity intervention projects.
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 |
|---|---|---|
| Actigraphy watch interventionParticipants in this group only will be given an Actigraphy watch to track their physical activity levels. | Device | Actigraphy watch intervention |
Primary outcome
Weight change at the end of the intervention at 10 weeks postpartum
Time frame: At 8-12 weeks postpartum from baseline (4-8 weeks postpartum)
Using measured weight in kgs
Weight change at the end of the intervention at 14 weeks postpartum
Time frame: At 12 to 16 weeks postpartum from baseline ( 4-8 weeks postpartum)
Using measured weight in kgs
11 secondary outcomes
Change in body mass index measures from baseline, 10 weeks postpartum and 14 weeks postpartum
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 10 weeks (8-12 week postpartum) and 14 weeks (12-16 weeks postpartum)
Change in glucose homeostasis markers from baseline at 10 weeks and 14 weeks postpartum
Time frame: Baseline, 10 weeks (8-12 weeks postpartum), and 14 weeks (12-16 weeks postpartum)
Change in blood pressure from baseline at 10 weeks and 14 weeks postpartum
Time frame: At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum)
Change in self-reported frequency of moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks
Time frame: At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum).
Change in self-reported duration of moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks
Time frame: At baseline, 10 weeks (8-12 weeks postpartum) and 14 weeks (12-16 weeks postpartum).
Change in duration of objective moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks
Time frame: Baseline, 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks (12-16 weeks).
Change in frequency of objective moderate to vigorous physical activity at baseline, 10 weeks and 14 weeks
Time frame: Baseline, 10 weeks postpartum (8-12 weeks postpartum) and 14 weeks (12-16 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 22176722Maturi 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.
- Background: PubMed 21085038Davenport 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.
- Derived from this study: PubMed 41917836Quah PL, Tan KH, Tan MH, Chern BSM. Evaluating wearable-supported exercise interventions for reducing postpartum weight: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Apr 1;26(1):515. doi: 10.1186/s12884-026-08937-1.
- Individual participant dataSharing planned: No. 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
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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. This study is not recruiting at the moment.
Bernard Su Min Chern, MD principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraphy watch intervention in people with Weight Change, 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 15 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change at the end of the intervention at 10 weeks postpartum (time frame: At 8-12 weeks postpartum from baseline (4-8 weeks postpartum)). 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 NCT07153081, which also lists 3 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 15 Sep 2025.