Wearable-Supported Exercise to Reduce Postpartum Weight

NCT ID: NCT07153081

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-09-12

Brief Summary

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

Detailed Description

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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

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Weight Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, single-center, unblinded intervention study with a 1:! allocation ratio.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Actigraphy watch intervention

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.

Group Type EXPERIMENTAL

Actigraphy watch intervention

Intervention Type DEVICE

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

Standard care group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Actigraphy watch intervention

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bernard Chern Su Min

Head & Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard Su Min Chern, MD

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type BACKGROUND
PMID: 22176722 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21085038 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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CIRB: Ref No.: 2017/3015

Identifier Type: -

Identifier Source: org_study_id

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