A Lifestyle Program on Healthy Weight in Postpartum Period

Weight Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620059
• Other study ID #: IR.TUMS.REC.1394.485
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: October 30, 2017

Study information

• Verified date: December 2015
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 30, 2017
• Est. primary completion date: February 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss
• Weight Reduction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Stress management changes	Stress will be assessed by the Health Promoting Lifestyle Profile (Adult Version) Scale.	Changes from baseline at 12 months postpartum
Other	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
Primary	Body weight changes	The investigators will assess body weight changes through BMI (kg/m2)	Changes from baseline at 12 months postpartum
Secondary	Dietary intake changes	The investigators will assess dietary intake changes with 24 hours dietary recall.	Changes from baseline at 12 months postpartum
Secondary	Physical activity changes	The pedometer will measure the number of steps.	Changes from baseline at 12 months postpartum