A Lifestyle Program on Healthy Weight in Postpartum Period

NCT ID: NCT02620059

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2017-10-30

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.

Conditions

Weight Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle Intervention

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IR.TUMS.REC.1394.485

Identifier Type: -

Identifier Source: org_study_id