Healthy Gestational Weight Gain Programme

Summary

This study aims to evaluate the efficacy of a multi-component lifestyle interventions during pregnancy on promoting appropriate gestational weight gain, preventing GDM, and improving pregnancy, delivery, and neonatal outcomes among overweight or obese pregnant women. The intervention strategies are developed based on the transtheoretical model and mobile health (via WeChat Public Account in smartphone), and will be conducted online and offline. This study will recruit and follow-up 200 overweight or obese singleton pregnant women (pre-pregnancy 24kg/m2≤BMI≤40 kg/m2) during the first trimester of pregnancy from Weifang Maternal and Child Health Hospital, Shandong Province, China, and Tongzhou Maternal and Child Health-care Institution, Beijing, China, with 100 pregnancy women in each institution. The 200 overweight or obese pregnant women will be randomly allocated at a 1:1 ratio to either the intervention or control group, stratified by the categorical variables of age, BMI and parity. Participants in the control group will be provided usual prenatal care. The lifestyle intervention will last for approximately 6 months (from 10-14 weeks to 32-36 weeks of gestation). Follow-up timepoints included 8-14 weeks of gestation, 24-28 weeks of gestation, 32-36 weeks of gestation. The interventions are composed of health education related to gestational weight gain and healthy lifestyles, diet modification, active physical activity, regular individual in-person and telephone sessions, diet behavior monitoring, physical activity monitoring, and weight monitoring with Huawei Wristband and WeChat Public Account. The hypothesis is that lifestyle interventions based on the transtheoretical model and mobile health will result in more appropriate gestational weight gain and lower risk of adverse pregnancy outcomes compared with usual care.

Conditions

• Gestational Weight Gain
• Overweight and Obesity

Interventions

BEHAVIORAL

behavioral interventions

The investigators set diet, physical activity, and weight goals for each participant. During the lifestyle intervention period, the participants need to complete weekly self-monitoring of weight, weekly recording of diet behavioral goals, timely exercise logging, online health education course learning by using the WeChat public account. They will receive corresponding timely reminder and tailored feedback in the form of graphical illustration and text according to diet, physical activity, and weight data collected by WeChat public account and Huawei Wristband. They will receive individual face to face or telephone sessions every 2 weeks to complete health education, goal review, motivational interview as well as collecting adverse events.

Sponsors & Collaborators

• Peking University Health Science Center-Weifang Joint Research Center for Maternal and Child Health

  collaborator UNKNOWN

• W.F. Maternal and Child Health Hospital

  collaborator UNKNOWN

• Tongzhou Maternal and Child Health-care Institution of Beijing

  collaborator UNKNOWN

• Peking University

  lead OTHER

Principal Investigators

• Haixue Wang, Doctor · Peking University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-19

Primary Completion

2025-03-31

Completion

2026-03-31

Countries

• China

Study Locations