Healthy Gestational Weight Gain Programme

NCT06370533 | Completed

• 1 other identifier: HGWG-pro
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Total gestational weight gain

  Weight at gestational week 32-36 minus pre-pregnancy weight (kilograms)

  From pre-pregnancy to gestational week 32-36

• Gestational weight gain before OGTT screening

  Gestational weight gain before OGTT screening at 24-28 weeks (kilograms)

  From pre-pregnancy to midterm (24-28 weeks)

Secondary Outcomes (8)

• Weekly rate of gestational weight gain between study clinical assessments

  Gestational weight gain from pre-pregnancy/baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)

• Proportion of women who exceed the IOM guidelines' weekly rate of gestational weight gain between clinical assessments

  From pre-pregnancy/baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)

• Rate of Gestational Diabetes Mellitus diagnosed according to International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria

  OGTT screening at 24-28 gestational weeks

• Rate of Preeclampsia/Gestational hypertension

  From 20 weeks of gestation to delivery

• Rate of Cesarean Section

  At delivery

Other Outcomes (17)

• Change of Blood pressure

  From baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)

• Change of body fat percentage (%)

  From baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)

• Change of fat free mass (kg)

  From baseline (8-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)

Study Arms (2)

lifestyle intervention

EXPERIMENTAL

Health education: Individual face to face or telephone sessions and online health education material. Diet behavior: The eight eating behavioral goals will be assigned to each participant with two for every 4-week cycle. Physical activity: Women will be advised to gradually attaining the goal of 150 minutes of moderate- to vigorous-intensity physical activity per week and walk at least 6000 steps per day. Weight monitoring: Self-monitoring of weight gain (regular self-weighing) and weight logging at least once a week was recommended.

Behavioral: behavioral interventions

usual-care control

NO INTERVENTION

Provision of usual prenatal care

Interventions

behavioral interventions BEHAVIORAL

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.

lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At 8-14 weeks of gestation
• Overweight or obese (pre-pregnancy 40 kg/m2≥BMI≥24 kg/m2) based on BMI recommendations of the Group of China Obesity Task Force of the Chinese Ministry of Health accounting for interracial differences (overweight BMI 24-28 kg/m2 and obese BMI≥28kg/m2)
• years of age
• Singleton pregnant
• Skilled at using smartphones and WeChat during pregnancy
• Attend regular antenatal care and plan delivery at W.F. Maternal and Child Health Hospital or Tongzhou Maternal and Child Health-care Institution of Beijing
• No contraindications to physical activity according to Physical Activity Readiness Questionnaire (PAR-Q)
• Willing to be randomized and cooperate with research and regular follow-up visits and sign informed consent.

You may not qualify if:

• Pre-pregnancy hypertension, severe cardiovascular and cerebrovascular diseases, respiratory disease, hepatic and renal disease, malignant tumors, systemic lupus erythematosus, thyroid disease, severe anemia, and other chronic consumptive diseases.
• Cervical insufficiency (historical painless cervical dilation leading to recurrent second-trimester births in the absence of other causes; dilated cervix on manual or speculum examination, etc.), multiple pregnancy, or continuous vaginal bleeding, etc.
• Diabetes before pregnancy
• Special dietary needs (e.g. , vegetarianism)
• Severe psychiatric disorders (serious mental health disorders including depression, anxiety, bipolar disorders, etc.)
• Cognitive impairment, visual impairment or hearing impairment
• History of bariatric surgery or surgical history involving important organs within 3 months
• Participated in other clinical trials within 6 months

Sponsors & Collaborators

• Peking University: lead
• W.F. Maternal and Child Health Hospital: collaborator
• Tongzhou Maternal and Child Health-care Institution of Beijing: collaborator
• Peking University Health Science Center-Weifang Joint Research Center for Maternal and Child Health: collaborator

Study Sites (2)

Tongzhou Maternal and Child Health-care Institution

Beijing, Beijing Municipality, China

Location

W.F. Maternal and Child Health Hospital；

Weifang, Shandong, China

Location

MeSH Terms

Conditions

Gestational Weight Gain; Overweight; Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Haixue Wang, Doctor

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 17, 2024
• Study Start: April 19, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)