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Completed

NCT Number: NCT07153081

Wearable-Supported Exercise to Reduce Postpartum Weight

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.

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Key information

Conditions

Weight Change Behavior Body Weight Body Weight Changes Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Above 21 years old
  • Viable singleton pregnancies
  • Physically fit to participate in moderate intensity walking.
  • 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.

Treatment and study plan

Actigraphy watch intervention

Device

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

    Calculating body mass index (kg/m2) using height (m) and weight (kg) measures

  2. 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)

    Using waist circumference measures in cm

  3. 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).

    Using waist circumference and hip measures

  4. 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)

    Using body fat mass percentage measured using the bioelectrical impedance analysis scale

  5. 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)

    Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples in mmol/L

  6. 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)

    Using fasting glucose and fasting insulin from blood samples in mmol/L

  7. 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)

    Using measured systolic and diastolic blood pressure in mm/Hg

  8. 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).

    Self-reported data from the International Physical Activity Questionnaire (IPAQ) to assess frequency of moderate to vigorous physical activity.

  9. 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).

    Self-reported data from the International Physical Activity Questionnaire (IPAQ) to assess duration of moderate to vigorous physical activity..

  10. 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).

    MVPA will be assessed using an Actigraphy accelerometer Duration: Average daily/weekly minutes of MVPA (minutes per week).

  11. 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).

    MVPA will be assessed using an Actigraphy accelerometer Frequency: Number of days per week with ≥30 minutes of MVPA (days per week).

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

Evaluating Wearable-supported Exercise Interventions for Reducing Postpartum Weight: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 3, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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