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NCT Number: NCT02620059

A Lifestyle Program on Healthy Weight in Postpartum Period

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.

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Key information

Conditions

Weight Reduction Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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 outcomes

  1. Body weight changes

    Time frame: Changes from baseline at 12 months postpartum

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

Secondary outcomes

  1. Dietary intake changes

    Time frame: Changes from baseline at 12 months postpartum

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

  2. Physical activity changes

    Time frame: Changes from baseline at 12 months postpartum

    The pedometer will measure the number of steps.

Other outcomes

  1. Postpartum weight retention changes

    Time frame: Changes from baseline at 12 months postpartum

    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.

  2. Stress management changes

    Time frame: Changes from baseline at 12 months postpartum

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

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

    Time frame: Changes from baseline at 12 months postpartum

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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Development and Evaluation of a Lifestyle Intervention Program for Women' Weight Reduction After Childbirth

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2015
Registry last updated
May 1, 2018

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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