A Lifestyle Program on Healthy Weight in Postpartum Period

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Reduction
• Intervention / Treatment: Behavioral: Lifestyle Intervention

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
No Intervention: Control; These women will receive general information via pamphlet about postpartum period and tips for stress management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight changes	The investigators will assess body weight changes through BMI (kg/m2)	Changes from baseline at 12 months postpartum

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Changes from baseline at 12 months postpartum
Stress management changes	Stress will be assessed by the Health Promoting Lifestyle Profile (Adult Version) Scale.	Changes from baseline at 12 months postpartum
Cognitive changes based on the selected behavior change model/s	Cognitive changes will be assessed through questionnaire developed based on behavior change model/s.	Changes from baseline at 12 months postpartum

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 19, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Postpartum Period
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: IR.TUMS.REC.1394.485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED