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CompletedNCT02620059Updated May 1, 2018

A Lifestyle Program on Healthy Weight in Postpartum Period

An interventional study of Lifestyle Intervention in Weight Reduction, sponsored by Tehran University of Medical Sciences. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The aim of this study is to examine the impact of lifestyle intervention on postpartum weight loss. So the investigators will have two groups in this study. In Experimental group women will receive the Healthy Lifestyle Intervention. This intervention will have been delivered during 12 weeks. In Control group women will receive general information via pamphlet about postpartum period and tips for stress management.

Read the detailed description

This study will be conducted in two phases. In the first phase , the investigators will conduct a cross-sectional study to assess factors related to the healthy lifestyle after childbirth based on the PRECEDE model. Regarding results of the study, the investigators will plan and implement a lifestyle promoting intervention and will evaluate the effect of the intervention on weight reduction among postpartum women.

02

Conditions studied

  • Weight Reduction

Keywords

  • Postpartum Period
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 100 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Singleton pregnancy
  • Lactating
  • Non-smoking
  • Full-term birth
  • Lack of medical problems
  • Lack of any pregnancy-related complications (eg, multiple pregnancy, fetal anomalies, fetal or maternal complications in current or previous pregnancy, and hypertension in pregnancy).
  • Nonparticipation in other studies which may affect the results.
  • 18.5≤ BMI≤29 before pregnancy
  • Women who are sedentary according to the International Physical Activity Questionnaire.

Exclusion criteria

Exclusion Criteria:

  • Unwilling to continue participation in the study
  • Pregnancy during the study
  • Suffering physical problems during the study
  • Smoking after birth
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Lifestyle Intervention

    Behavioral: Lifestyle Intervention These women will receive the Healthy Lifestyle Intervention. This intervention will have been delivered during 12 weeks, which will be Distance learning program (multimedia or internet). During the intervention (12 weeks) and follow up period, women will receive not only motivational messages through the Short Message System (SMS) but also a pedometer to record their steps.The intervention will focus on women increasing physical activity (walking) to 10'000 steps per day and receiving healthy eating guidelines. This intervention curriculum will cover topics related to healthy eating, physical activity, and stress management during postpartum. General information about postpartum period will also be provided.

    Behavioral: Lifestyle Intervention

  • No intervention
    Control

    These women will receive general information via pamphlet about postpartum period and tips for stress management.

Interventions

  • BehavioralLifestyle Intervention

    The investigators will provide information on healthy eating and physical activity. They will give pedometers to the participants to monitor their daily steps in order to increase it till 10000 steps/day.

06

What researchers measure

Primary outcomes

  1. Body weight changes

    The investigators will assess body weight changes through BMI (kg/m2)

    Time frame: Changes from baseline at 12 months postpartum

Secondary outcomes

  1. Dietary intake changes

    The investigators will assess dietary intake changes with 24 hours dietary recall.

    Time frame: Changes from baseline at 12 months postpartum

  2. Physical activity changes

    The pedometer will measure the number of steps.

    Time frame: Changes from baseline at 12 months postpartum

Other outcomes

  1. Postpartum weight retention changes

    Postpartum weight retention will be measured by calculating the difference between weight at a certain time in the postpartum period and weight before pregnancy using a weight scale.

    Time frame: Changes from baseline at 12 months postpartum

  2. Stress management changes

    Stress will be assessed by the Health Promoting Lifestyle Profile (Adult Version) Scale.

    Time frame: Changes from baseline at 12 months postpartum

  3. Cognitive changes based on the selected behavior change model/s

    Cognitive changes will be assessed through questionnaire developed based on behavior change model/s.

    Time frame: Changes from baseline at 12 months postpartum

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02620059
Lead sponsor
Tehran University of Medical Sciences
Responsible party
Sponsor
First posted
Dec 2, 2015
Start date
Sep 1, 2016
Primary completion
Feb 19, 2017
Completion
Oct 30, 2017
Last update
May 1, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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