The Effect of Individualized Exercise Guidance on Pregnancy Outcome

NCT ID: NCT05760768

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-09-30

Brief Summary

A single center, randomized controlled trial was conducted to investigate whether individualized exercise guidance was more effective in improving pregnancy outcomes in normal pregnant women. What's more, the trial was also conducted to find out whether there is a mediating effect between prenatal exercise and pregnancy outcomes.

Detailed Description

Fetal macrosomia refers to newborns with a birth weight more than 4000 grams, which poses varying degrees of risks to the health of both mother and infant and also affects the health outcomes of future generations. Research has found that exercise can effectively reduce the incidence of macrosomia and prevent gestational diabetes mellitus, pregnancy-induced hypertension, and excessive weight gain during pregnancy. However, every pregnant woman's individual situation and exercise habits are different, and personalized guidance based on their own circumstances is necessary during pregnancy exercise. The use of intelligent devices for supervision and management is also essential. To explore the impact of personalized exercise guidance during pregnancy on macrosomia, as well as the mediating effect of weight gain during pregnancy on exercise and macrosomia, we conducted a prospective randomized controlled clinical trial. The study included pregnant women who were over 20 years old, married, singleton, in the mid-term of pregnancy, and had no contraindications for exercise during pregnancy. They were randomly divided into an individualized exercise guidance group and standard clinic prenatal care group. Both groups received routine prenatal care and did not have any special dietary recommendations. The pregnant women in the individualized exercise guidance group received regular exercise guidance from a professional teacher and were supervised and managed through a WeChat group. The main outcome indicators were the incidence of macrosomia and the total weight gain during pregnancy.

Conditions

Pregnancy Outcome; Gestational Weight Gain; Mediation; Macrosomia, Fetal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Individualized exercise guidance group

Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.

Group Type: EXPERIMENTAL

Individualized exercise guidance

Intervention Type: BEHAVIORAL

Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.

Standard clinic prenatal care (control) group

Participants accept regular routine prenatal care following Chinese standard.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individualized exercise guidance

Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged between 18 and 45 years.
• With singleton pregnancy.
• Second trimester.
• No contraindications to exercise during pregnancy.
• Be able to use smart phone for chatting, read and write basic Chinese.
• Volunteer for research.

Exclusion Criteria

• Adverse pregnancy reaction, such as abdominal pain, vaginal bleeding and so on.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liangkun Ma

Role: STUDY_DIRECTOR

Peking union medical college hosiptal

Locations

Department of ob gyn, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Yang X, Wang G, Liu N, Wang Y, Zhang S, Lin H, Zhu C, Liu L, Sun Y, Ma L. Mediating effect of gestational weight gain on the preventive effect of exercise during pregnancy on macrosomia: a randomized clinical trial. BMC Pregnancy Childbirth. 2024 May 22;24(1):384. doi: 10.1186/s12884-024-06527-7.

Reference Type: DERIVED

PMID: 38778289 (View on PubMed)

Other Identifiers

018

Identifier Type: -

Identifier Source: org_study_id