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A Lifestyle Program on Healthy Weight in Postpartum Period

Primary Purpose

Weight Reduction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Reduction focused on measuring Postpartum Period

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Lifestyle Intervention

    Control

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Dietary intake changes
    The investigators will assess dietary intake changes with 24 hours dietary recall.
    Physical activity changes
    The pedometer will measure the number of steps.

    Full Information

    First Posted
    October 19, 2015
    Last Updated
    April 29, 2018
    Sponsor
    Tehran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02620059
    Brief Title
    A Lifestyle Program on Healthy Weight in Postpartum Period
    Official Title
    Development and Evaluation of a Lifestyle Intervention Program for Women' Weight Reduction After Childbirth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    February 19, 2017 (Actual)
    Study Completion Date
    October 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tehran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Reduction
    Keywords
    Postpartum Period

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    These women will receive general information via pamphlet about postpartum period and tips for stress management.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Body weight changes
    Description
    The investigators will assess body weight changes through BMI (kg/m2)
    Time Frame
    Changes from baseline at 12 months postpartum
    Secondary Outcome Measure Information:
    Title
    Dietary intake changes
    Description
    The investigators will assess dietary intake changes with 24 hours dietary recall.
    Time Frame
    Changes from baseline at 12 months postpartum
    Title
    Physical activity changes
    Description
    The pedometer will measure the number of steps.
    Time Frame
    Changes from baseline at 12 months postpartum
    Other Pre-specified Outcome Measures:
    Title
    Postpartum weight retention changes
    Description
    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
    Title
    Stress management changes
    Description
    Stress will be assessed by the Health Promoting Lifestyle Profile (Adult Version) Scale.
    Time Frame
    Changes from baseline at 12 months postpartum
    Title
    Cognitive changes based on the selected behavior change model/s
    Description
    Cognitive changes will be assessed through questionnaire developed based on behavior change model/s.
    Time Frame
    Changes from baseline at 12 months postpartum

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: Unwilling to continue participation in the study Pregnancy during the study Suffering physical problems during the study Smoking after birth

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Lifestyle Program on Healthy Weight in Postpartum Period

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