A Lifestyle Program on Healthy Weight in Postpartum Period

Not Applicable

Completed

• Conditions: Weight Reduction
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT02620059
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-11-30
• Status Verified: 2015-12
• Study First Posted: 2015-12-02
• Study Start: 2016-09-01
• Primary Completion: 2017-02-19
• Study Completion: 2017-10-30
• Last Update Submitted: 2018-04-29
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	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.

Primary Outcome Measures

Name	Time	Method
Body weight changes	Changes from baseline at 12 months postpartum	The investigators will assess body weight changes through BMI (kg/m2)

Secondary Outcome Measures

Name	Time	Method
Physical activity changes	Changes from baseline at 12 months postpartum	The pedometer will measure the number of steps.
Dietary intake changes	Changes from baseline at 12 months postpartum	The investigators will assess dietary intake changes with 24 hours dietary recall.