Diet and Lifestyle Intervention Study in Postpartum Women in China

NCT01039051 | Unknown Phase 2 DMC

• 1 other identifier: 2008BA158B07
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Changes in the knowledge and belief about postpartum practice among the women

  December 2009

Secondary Outcomes (1)

• Changes in the nutritional status, postpartum recovery and health status

  June 2010

Study Arms (1)

Diet and Lifestyle counseling

EXPERIMENTAL

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.

Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Women

Interventions

Diet and Lifestyle Intervention in Chinese Postpartum Women BEHAVIORAL

For individual postpartum woman, we will set antepartum participatory training courses, provide specially prepared brochures and supporting VCD, set up a specialized counseling hotline and give individual bedside guidance after birth. For their family members, we will invite every postpartum woman's husband and mother to take part in workshops or seminars, making them know some basic knowledge of postpartum care, and persuading them to promote adoption of the diet and lifestyle we advocated by the postpartum woman. For community environment, we will put up posters about basic knowledge of postpartum care in the community bulletin boards for general population educating and mobilize community leaders and heads from and maternal and child health centers for maximum support.

Also known as: Multicenter trial for Postpartum practice

Diet and Lifestyle counseling

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \<20 or \>40 years old

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Qingdao University: collaborator
• Southern Medical University, China: collaborator
• Centers for Disease Control and Prevention, China: collaborator

Study Sites (3)

Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Qingdao University

Qingdao, Shandong, 266021, China

RECRUITING

Related Publications (1)

• Bao W, Ma A, Mao L, Lai J, Xiao M, Sun G, Ouyang Y, Wu S, Yang W, Wang N, Zhao Y, Fu J, Liu L. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial. BMC Public Health. 2010 Feb 27;10:103. doi: 10.1186/1471-2458-10-103.

  PMID: 20187965 DERIVED

MeSH Terms

Conditions

Puerperal Infection; Fever; Constipation; Hemorrhoids; Fissure in Ano; Breast Diseases; Oral Ulcer; Anemia

Interventions

Diet; Multicenter Studies as Topic

Condition Hierarchy (Ancestors)

Pregnancy Complications, Infectious; Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Anus Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Diseases; Stomatognathic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Liegang Liu, PhD

  Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Liegang Liu, PhD

CONTACT

+86-27-83650522; liegangliu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: December 24, 2009

Record last verified: 2009-12

Locations

CN (3)