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北京大学学报（医学版） ›› 2025, Vol. 57 ›› Issue (3): 465-472. doi: 10.19723/j.issn.1671-167X.2025.03.009

• 论著 • 上一篇    下一篇

基于移动健康技术对超重或肥胖孕妇体重管理的随机对照试验

李萍1, 王海雪1, 高晓2, 韩亚静2, 王辉1, 王海俊1,*(), 牟莹莹2,*()   

  1. 1. 北京大学公共卫生学院妇幼卫生学系/北京大学医学部-潍坊市妇幼健康联合研究中心/国家卫生健康委员会生育健康重点实验室, 北京 100191
    2. 潍坊市妇幼保健院, 山东潍坊 261011
  • 收稿日期:2025-02-08 出版日期:2025-06-18 发布日期:2025-06-13
  • 通讯作者: 王海俊, 牟莹莹
  • 基金资助:
    北京大学医学部-潍坊市妇幼健康联合研究中心(PKUWF-Y09)

A randomized controlled trial of weight management based on mobile health techno-logy among overweight or obese pregnant women

Ping LI1, Haixue WANG1, Xiao GAO2, Yajing HAN2, Hui WANG1, Haijun WANG1,*(), Yingying MU2,*()   

  1. 1. Department of Maternal and Child Health, Peking University School of Public Health / Peking University Health Science Center-Weifang Joint Research Center for Maternal and Child Health / National Health Commission Key Laboratory of Reproductive Health, Beijing 100191, China
    2. Weifang Maternal and Child Health Center, Weifang 261011, Shandong, China
  • Received:2025-02-08 Online:2025-06-18 Published:2025-06-13
  • Contact: Haijun WANG, Yingying MU
  • Supported by:
    Peking University Health Science Center-Weifang Maternal and Child Health Joint Research Center(PKUWF-Y09)

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摘要：

目的: 评估基于移动健康技术的生活方式干预对超重或肥胖妇女的孕期体重管理的有效性，探索干预效果的影响因素，为超重或肥胖妇女的孕期体重管理提供科学依据。方法: 采用随机对照试验设计，于2024年4—8月招募200名18~40岁的孕前超重或肥胖的孕早期单胎孕妇，根据体重指数(body mass index，BMI)分类、年龄、产次进行分层区组随机化。对照组接受常规诊疗和保健，干预组接受基于移动健康技术的生活方式干预，包括每2周1次面对面或电话随访；指导孕妇在微信公众号记录每周饮食行为目标实现情况并提供个性化反馈；每天走6 000步，每周健步走150 min；每周记录1次体重并进行个性化反馈。基于意向性分析原则，利用广义线性混合模型分析干预对孕24~28周前增重及增重速率、妊娠糖尿病和饮食运动行为的影响。采用亚组分析和交互作用分析，探索孕24~28周前增重干预效果是否受孕妇不同特征影响。结果: 干预组和对照组孕妇的平均年龄分别为(30.49±3.99)岁、(29.83±3.95)岁，入组孕周分别为(11.35±1.61)周、(11.26±1.52)周，两组基线特征差异均无统计学意义(P均>0.05)。干预组和对照组分别失访10人和12人，共计178名孕妇完成中期随访。孕24~28周中期随访时，干预组和对照组分别增重(5.00±3.72) kg和(6.57±4.28) kg，调整年龄、孕次、产次、地区、孕前BMI分类、社会经济状况等协变量后，孕24~28周前增重的组间差异为-1.63 kg(95%CI：-2.80~-0.46；P=0.007)，增重速率的组间差异为-0.07 kg/周(95%CI：-0.11~-0.02；P=0.005)。与对照组相比，干预组口服葡萄糖耐量试验(oral glucose tolerance test，OGTT)空腹血糖降低0.19 mmol/L(95%CI：0.04~0.33；P=0.013)。两组妊娠糖尿病发生率差异无统计学意义。在年龄、地区、社会经济水平、产次等因素的不同亚组中，孕期体重干预效果差异无统计学意义。结论: 基于移动健康技术的生活方式干预能有效控制超重或肥胖妇女的孕24~28周前增重，并改善空腹血糖。

关键词: 孕期体重增长, 超重, 肥胖, 随机对照试验, 移动健康

Abstract:

Objective: To evaluate the effect of lifestyle interventions based on mobile health technology on gestational weight gain among overweight or obese pregnant women, to explore the influencing factors of the intervention effect, and to provide scientific evidence for weight management during pregnancy. Methods: The randomized controlled trial (RCT) design was used. From April 2024 to August 2024, 200 singleton overweight or obese pregnant women aged 18-40 years in early pregnancy were recruited and stratified block-randomized according to body mass index (BMI) categories, age, and parity. The control group received routine prenatal care, while the intervention group received lifestyle interventions based on mobile health technology, which included biweekly face-to-face or telephone sessions; weekly recording of dietary behavior goals with personalized feedback on WeChat public account; 6 000 steps per day and 150 minutes of brisk walking per week; and weekly weight recording with personalized feedback. Based on the intention-to-treat principle, generalized linear mixed models were used to analyze the effects on weight gain and weight gain rate up to 24-28 gestational weeks, gestational diabetes mellitus (GDM), and dietary and physical activity behaviors. Additionally, subgroup analysis and interaction analysis were conducted to explore whether intervention effects on weight gain varied by different maternal characteristics. Results: The mean age of the women in the intervention and control groups was (30.49± 3.99) years and (29.83±3.95) years, respectively, with gestational weeks at enrollment being (11.35±1.61) weeks and (11.26±1.52) weeks. No statistically significant differences were observed in the baseline characteristics between the two groups (P>0.05). In the study, 10 and 12 participants were lost to the follow-up in the intervention and control groups, respectively, with 178 women completing the midterm follow-up. At the midterm follow-up (24-28 weeks), the weight gain in the intervention and control groups was (5.00±3.72) kg and (6.57±4.28) kg, respectively. After adjusting for age, parity, gravidity, region, pre-pregnancy BMI categories, and socioeconomic status, the between-group difference was -1.63 kg (95%CI: -2.80 to -0.46; P=0.007). The adjusted between-group difference in weight gain rate was -0.07 kg/week (95%CI: -0.11 to -0.02; P=0.005). Compared with the control group, the intervention group had lower fasting blood glucose at the oral glucose tolerance test (OGTT) by 0.19 mmol/L (95%CI: 0.04 to 0.33; P=0.013). No significant difference was observed in GDM incidence between the two groups. Among different subgroups based on characteristics, such as age, region, socioeconomic status, and parity, there was no statistically significant dif-ference in the effect on weight gain. Conclusion: The lifestyle interventions based on mobile health technology effectively controlled weight gain up to 24-28 gestational weeks among overweight or obese women and improved fasting blood glucose level. This has significant public health implications for improving the health of overweight or obese pregnant women in China.

Key words: Gestational weight gain, Overweight, Obesity, Randomized controlled trial, Mobile health

中图分类号: 

  • R715.3

表1

研究对象基线特征"

Variable All (n=200) Control group (n=100) Intervention group (n=100) P value
Age/years 30.16±3.97 29.83±3.95 30.49±3.99 0.244
Gestational age/weeks 11.31±1.56 11.26±1.52 11.35±1.61 0.504
Pre-pregnancy BMI/(kg/m2) 27.88±3.25 27.68±3.03 28.08±3.45 0.596
Overweight 122 (61.0%) 61 (61.0%) 61 (61.0%) >0.999
Associate degree or above 169 (84.5%) 86 (86.0%) 83 (83.0%) 0.558
Employed 152 (76.0%) 75 (75.0%) 77 (77.0%) 0.741
Green score 64.89±8.63 64.83±8.53 64.95±8.76 0.824
Gravidity 0.752
  1 93 (46.5%) 49 (49.0%) 44 (44.0%)
  2 70 (35.0%) 34 (34.0%) 36 (36.0%)
  ≥3 37 (18.5%) 17 (17.0%) 20 (20.0%)
Primiparous 133 (66.5%) 69 (69.0%) 64 (64.0%) 0.454
Natural conception 188 (95.4%) 95 (96.0%) 93 (94.9%) 0.747
PCOS history 25 (12.5%) 10 (10.0%) 15 (15.0%) 0.285
Diabetes family history 46 (23.0%) 24 (24.0%) 22 (22.0%) 0.737
GDM history 3 (1.5%) 2 (2.0%) 1 (1.0%) >0.999
Nausea 126 (63.0%) 63 (63.0%) 63 (63.0%) >0.999
MET-min/week 622.12±716.18 645.17±840.43 599.07±568.87 0.167
Daily steps 3 882±2 685 3 680±2 277 4 081±3 030 0.486
Energy intake/(kcal/d) 1 935±585 1 887±574 1 982±595 0.203
Protein intake/(g/d) 74.53±24.41 73.00±24.42 76.05±24.43 0.282
Carbohydrate intake/(g/d) 303.63±100.55 297.07±98.06 310.19±103.05 0.323
Fat intake/(g/d) 48.48±19.23 46.73±19.74 50.24±18.63 0.143
DBI_P 14.88±8.83 14.12±8.65 15.64±8.98 0.214

表2

干预组和对照组增重情况"

Variables Intervention group (n=90) Control group (n=88) MD/RR (95%CI) P value
GWG/kg 5.00±3.72 6.57±4.28 -1.63 (-2.80, -0.46) 0.007
GWG rate/(kg/week) 0.19±0.14 0.25±0.17 -0.07 (-0.11, -0.02) 0.005
T1-T2 GWG/kg 4.53±2.79 5.80±3.94 -1.33 (-2.33, -0.33) 0.010
T1-T2 GWG rate/(kg/week) 0.31±0.19 0.40±0.27 -0.09 (-0.16, -0.03) 0.008
28-week GWG/kg 5.57±3.78 7.83±4.40 -2.23 (-3.40, -1.06) < 0.001
EGWG 41 (46.1%) 50 (58.8%) 0.51 (0.27, 0.96) 0.036
IGWG 25 (28.1%) 16 (18.8%) 1.94 (0.91, 4.09) 0.084
AGWG 23 (25.8%) 19 (22.4%) 1.32 (0.66, 2.63) 0.439

表3

干预组和对照组的饮食运动情况"

Variables Intervention group (n=90) Control group (n=88) MD (95%CI) P value
Baseline Midterm Baseline Midterm
MET-min/week 599.1±568.9 1 070.8±831.0 645.2±840.4 681.6±551.6 412.70 (211.27, 614.13) < 0.001
Daily steps 4 081±3 030 5 213±2 382 3 680±2 277 3 795±2 386 1 189 (547, 1 830) < 0.001
Energy intake/(kcal/d) 1 982±595 1 804±537 1 887±574 2 032±736 -250.2 (-441.9, -58.5) 0.011
Protein intake/(g/d) 76.05±24.43 77.83±21.75 73.00±24.42 82.65±28.15 -6.03 (-13.41, 1.34) 0.111
Carbohydrate intake/(g/d) 310.2±103.0 265.6±103.6 297.1±98.1 306.0±124.1 -43.41 (-77.42, -9.39) 0.013
Fat intake/(g/d) 50.24±18.63 51.19±14.50 46.73±19.74 55.69±23.28 -5.26 (-10.99, 0.48) 0.074
DBI_P 15.64±8.98 13.60±9.17 14.12±8.65 15.33±9.87 -2.32 (-5.04, 0.40) 0.097

表4

不同特征孕妇的增重(kg)干预效果"

Variables Intervention group (n=90) Control group (n=88) MD (95%CI) P value P value for interaction
Age 0.191
  ≥30 years 5.53±3.29 6.25±3.44 -0.90 (-2.30, 0.50) 0.210
   < 30 years 4.32±4.15 6.83±4.90 -2.30 (-4.20, -0.39) 0.021
BMI categories 0.982
  Overweight 5.71±3.34 7.36±4.34 -1.40 (-2.90, 0.10) 0.070
  Obese 3.84±4.05 5.31±3.93 -1.49 (-3.45, 0.47) 0.141
Region 0.493
  Weifang, Shandong 5.21±3.67 7.34±4.70 -1.76 (-3.48, -0.04) 0.048
  Tongzhou, Beijing 4.78±3.80 5.61±3.52 -1.30 (-2.92, 0.31) 0.117
Parity 0.882
  Primiparous 4.72±3.95 6.52±4.80 -1.63 (-3.2, -0.07) 0.043
  Multiparous 5.48±3.30 6.68±2.57 -1.39 (-3.07, 0.29) 0.111
Socioeconomic status 0.834
  Higher 5.38±2.97 7.01±4.64 -1.91 (-3.51, -0.32) 0.021
  Lower 4.57±4.41 6.13±3.89 -1.62 (-3.42, 0.17) 0.080
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ISSN 1671-167X
CN 11-4691/R
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