Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform

NCT04989634 | Unknown DMC

• 1 other identifier: 2019-KY-036-02
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

With the opening up of the two-child policy , the composition of pregnant women in China has changed significantly . The proportion of high-risk pregnant women in the elderly has increased significantly , and the risk of adverse pregnancy outcomes has also increased . Among them , gestational diabetes mellitus ( GDM ) is the most common complication during pregnancy . The incidence of GDM in China is as high as 18 % due to the economic growth , lifestyle changes and dietary habits . GDM not only threatens perinatal maternal and child health , but also increases the risk of offspring insulin resistance , obesity and metabolic diseases in adulthood . But it is still lack of experience on intervening and managing them effectively. Therefore , on the basis of previous studies , this study intends to explore the effects of intensive diet and exercise intervention by obstetricians and nutritionists on pregnancy weight gain , pregnancy outcome , glucose and lipid metabolism and postpartum weight retention under the mobile medical platform through a large sample cluster intervention test in the real world. In order to supervise and improve the compliance of the intervention subjects and realize the ultimate change of their behaviors, this study intends to use the APP software, the mobile medical technology, to monitor and evaluate diet , exercise and weight. Through the above research , it aims to improve the current management schemes of diet and weight during pregnancy , not only helps to optimize and improve the quality of perinatal health care , but also prevents the adult chronic diseases from the fetal period. This research has important theoretical and practical value .

Conditions

Gestational Diabetes Mellitus; Hypertensive Disorder of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Incidence of gestational diabetes mellitus

  From enrollment to 24-28 weeks of gestation

Secondary Outcomes (3)

• Incidence of gestational hypertension

  From date of randomization until the date of delivery, assessed up to 9 months

• Incidence of cesarean section

  From date of randomization until the date of delivery, assessed up to 9 months

• Incidence of premature birth

  From date of randomization until the date of delivery, assessed up to 9 months

Study Arms (2)

standard care

ACTIVE COMPARATOR

In the early pregnancy ( 8-12 weeks of pregnancy ) , a group education on dietary weight management will be carried out according to the current medical system and the regulations of our hospital , followed by routine prenatal examination . According to the corresponding diagnosis and treatment guidelines, examinations and follow-up interventions will be carried out if the metabolic diseases are occurred during pregnancy.

Behavioral: Standard care

dietary and weight management

EXPERIMENTAL

A randomized controlled trial in pregnant women will be initiated at 8-12 weeks of gestation util delivery. The intervention contents included health education , nutritional analysis and individualized dietary guidance combined with mobile medical treatment and face-to-face teaching during the early , middle and late pregnancy stages.

Behavioral: Intensive dietary and weight management

Interventions

Intensive dietary and weight management BEHAVIORAL

health education , nutritional analysis and individualized dietary guidance

dietary and weight management

Standard care BEHAVIORAL

Standard prenatal education on diet, nutrition and physical activity

standard care

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Regular check-ups in our hospital
• years old
• gestational weeks

You may not qualify if:

• Patients with incomplete medical records

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, 100026, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Toxemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Guanghui Li, MD, PhD

  Beijing Obstetrics and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guanghui Li, MD, PhD

CONTACT

008613124728821; liguanghui2007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: July 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

CN (1)