Diet and Lifestyle Intervention Study in Postpartum Women in China

H

Huazhong University of Science and Technology

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Anemia
Fever
Breast Disease
Anal Fissure
Oral Ulcers
Constipation
Hemorrhoids
Puerperal Infection

Treatments

Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Women

Study type

Interventional

Funder types

Other

Identifiers

NCT01039051
2008BA158B07

Details and patient eligibility

About

Previous studies have shown "Doing the month", a traditional practice for postpartum women in China and other Asian countries, may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women.

Full description

The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n>=400) and the control group (n>=400). A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention.

Enrollment

1,600 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy pregnant women
  • at their third trimester
  • had at least three routine examinations at these antenatal clinics

Exclusion criteria

<20 or >40 years old

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,600 participants in 1 patient group

Diet and Lifestyle counseling
Experimental group
Description:
increasing consumption of vegetables and fruits; maintaining energy balance through reducing excessive energy from meat, eggs and brown sugar and increasing energy expenditure from appropriate physical activity, such as doing maternal keep-fit exercises.
Treatment:
Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Women

Trial contacts and locations

0

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Central trial contact

Liegang Liu, PhD

Data sourced from clinicaltrials.gov

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