A Lifestyle Program on Healthy Weight in Postpartum Period

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02620059

Collaborator

(none)

100

Enrollment

Arms

13.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Reduction	Behavioral: Lifestyle Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Feb 19, 2017

Actual Study Completion Date :

Oct 30, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Postpartum weight retention changes [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.
Stress management changes [Changes from baseline at 12 months postpartum]
Stress will be assessed by the Health Promoting Lifestyle Profile (Adult Version) Scale.
Cognitive changes based on the selected behavior change model/s [Changes from baseline at 12 months postpartum]
Cognitive changes will be assessed through questionnaire developed based on behavior change model/s.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02620059

Other Study ID Numbers:

IR.TUMS.REC.1394.485

First Posted:

Dec 2, 2015

Last Update Posted:

May 1, 2018

Last Verified:

Dec 1, 2015

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Tehran University of Medical Sciences

Postpartum Period

Additional relevant MeSH terms:

Body Weight

Weight Loss

Study Results

No Results Posted as of May 1, 2018