A Lifestyle Program on Healthy Weight in Postpartum Period

NCT02620059 | Completed

• 1 other identifier: IR.TUMS.REC.1394.485
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight Reduction

Keywords

Postpartum Period

Outcome Measures

Primary Outcomes (1)

• Body weight changes

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

  Changes from baseline at 12 months postpartum

Secondary Outcomes (2)

• Dietary intake changes

  Changes from baseline at 12 months postpartum

• Physical activity changes

  Changes from baseline at 12 months postpartum

Other Outcomes (3)

• Postpartum weight retention changes

  Changes from baseline at 12 months postpartum

• Stress management changes

  Changes from baseline at 12 months postpartum

• Cognitive changes based on the selected behavior change model/s

  Changes from baseline at 12 months postpartum

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• ≤ BMI≤29 before pregnancy
• Women who are sedentary according to the International Physical Activity Questionnaire.

You may not qualify if:

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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: December 2, 2015
• Study Start: September 1, 2016
• Primary Completion: February 19, 2017
• Study Completion: October 30, 2017
• Last Updated: May 1, 2018

Record last verified: 2015-12