Healthy Gestational Weight Gain Programme

Overweight and Obesity Clinical Trial

Official title:

The Effects of Mobile Health Based Lifestyle Intervention on Gestational Weight Gain in Pregnant Women With Overweight and Obesity: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370533
• Other study ID #: HGWG-pro
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: Peking University
• Contact: Haixue Wang, Doctor
• Phone: 13041196856
• Email: gwwanghaixue[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 BMI≥24 kg/m2) during the first trimester of pregnancy from Weifang maternal and Child Health Center, Shandong Province, China. 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 10-14 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 smart watch. 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.

Description:

Overweight and obesity is a major public health problem among women in reproductive age. Excessive gestational weight gain (EGWG) among this group is becoming a worldwide epidemic over recent decades. EGWG is associated with adverse outcomes including increased risk of developing gestational diabetes mellitus (GDM), cesarean section, hypertensive disorders of pregnancy (HDP), elevated infant birth weight and adiposity, and increased risk of metabolic syndrome and childhood obesity in offspring. Therefore, interventions are needed to help overweight and obesity pregnant women to control GWG.

Lifestyle intervention has been proved effective on weight management during pregnancy. However, the effects of interventions on controlling overweight and obesity women's GWG are inconsistent. Traditional face-to-face counseling are less cost effective. Effective intervention models based on Mobile health that can be scaled up are scarcity. Thus, this randomized controlled trial aims to identify: firstly, whether the mobile health lifestyle interventions will be effective on improving gestational weight gain and preventing GDM among overweight or obese pregnant women; secondly, whether the intervention will be beneficial for improving pregnancy outcomes, delivery outcomes, neonatal outcomes, metabolic indicators, body composition indicators, etc. among overweight or obese pregnant women.

The interventions are composed of health education (online and offline health education on recommended gestational weight gain, prenatal dietary guidance and physical activity recommendation), diet modification (8 core dietary goal setting and monitoring weekly), active physical activity (150 min per week of moderate-to vigorous-intensity physical activity including aerobic exercise (brisk walking) and resistance exercise; goal of 6000 steps/day), regular face to face or telephone sessions, lifestyle (diet and physical activity behavior) and weight monitoring via Huawei smart watch. Tailoring of the intervention will be guided by the transtheoretical model. A total of 200 overweight or obese singleton pregnant women of 10-14 weeks of gestation will be recruited and they 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.

Women in both study arms will attend three research appointments at 10-14 weeks (baseline),24-28 weeks (midterm) and 32-36 (terminal) weeks of gestation for data collection via questionnaires, physical measurements, and clinical laboratory examination. Information on demography, socioeconomic status, medical and family history, obstetric history, current pregnancy information, smoking, consumption of alcohol, attitude and knowledge about GWG, diet and exercise habits, sleep situation, quality of life, mental health (depression, anxiety), social support, self-efficacy, etc. will be collected with questionnaires and interviews by research stuff. Physical measurements including weight, height, blood pressure, and body composition using bioelectrical impedance (BIA) will be obtained using standardized methods. Laboratory tests performed in conjunction with antenatal visits include a 75 g 2-hour oral glucose tolerance test (OGTT). Data on mode of delivery, gestational age at birth, birth weight, Apgar scores, perinatal complications, etc. will be obtained from patient records. In addition, blood and urine samples will be drawn at three appointments and a sample of cord blood will be collected at birth. Maternal postpartum weight (42 days,6 months,1 year after delivery) will be obtained through routine physical examination or telephone follow-up, offspring physical growth indicators, such as height, weight, head circumference, etc., were collected from routine physical examination in 42 days,6 months and 12 months of age.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. At 10-14 weeks of gestation

2. Overweight or obese (pre-pregnancy 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)

3. 18-40 years of age

4. Singleton pregnant

5. Skilled at using smartphones and WeChat during pregnancy

6. Attend regular antenatal care and plan delivery at W.F. Maternal and Child Health Hospital

7. No contraindications to physical activity according to Physical Activity Readiness Questionnaire (PAR-Q)

8. Willing to be randomized and cooperate with research and regular follow-up visits and sign informed consent.

Exclusion Criteria:

1. 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.

2. 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.

3. Diabetes before pregnancy

4. Special dietary needs (e.g. , vegetarianism)

5. Severe psychiatric disorders (serious mental health disorders including depression, anxiety, bipolar disorders, etc.)

6. Cognitive impairment, visual impairment or hearing impairment

7. History of bariatric surgery or surgical history involving important organs within 3 months

8. Participation in other clinical trials within 6 months

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Obesity
• Overweight
• Overweight and Obesity
• Weight Gain

Intervention

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 official 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 official account and Huawei smart watch. They will receive individual in-person or telephone sessions every 2 weeks to complete health education, goal review, motivational interview as well as collecting adverse events.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	W.F. Maternal and Child Health Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Blood pressure	Systolic blood pressure and diastolic blood pressure (mmHg) will be measured by using electronic sphygmomanometer	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of body fat percentage (%)	measure body fat percentage by bioelectrical impedance analysis	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of fat free mass (kg)	measure body fat free mass by bioelectrical impedance analysis	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of muscle mass (kg)	measure muscle mass by bioelectrical impedance analysis	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of handgrip strength (kg)	Handgrip strength measured by grip strength gauge(kg)	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of Attitude and knowledge	Attitude and knowledge about gestational weight gain and weight management measured by 8 questions: ?Perceived weight category; ?The importance of knowing the recommended weight gain during pregnancy ?The best amount of weight to gain in pregnancy ?The harm of too much weight gain in pregnancy for the mother ?The harm of too much weight gain in pregnancy for the baby ?Whether the energy needs vary according to the early, middle and late stages of pregnancy ?Is it right to eat for two during pregnancy? ?Ways to manage weight gain in pregnancy According to each question pregnant women answer the correct or not to score, answer the correct for 1 point, error for 0, the total score ranged form 0 to 8 points. The higher the score the more healthy attitude and knowledge	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of dietary intake	Dietary intake measured by food frequency questionnaire (FFQ) investigating the frequency of food consumption over the past one month. The die balance index for pregnancy will be obtained according to whether the food intake of pregnant women reached the Chinese standard for pregnant women. The die balance index for pregnancy include low bound score (-60 to 0) , high bound score (0 to 44) and die quality distance (-60 to 44) . The closer these three scores get to 0, the healthier the pregnant woman's diet.	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of physical activity	Physical activity will be measured by International Physical Activity Questionnaire-Short Form (IPAQ-SF). It asks about the frequency and duration of various types of physical activities over the past 7 days. The metabolic equivalent (MET) for different types of activities will be calculated as below and the higher score means the higher physical activity level: walking MET-minutes/week = 3.3 × walking minutes × walking days; moderate MET-minutes/week = 4.0 × moderate-intensity activity minutes × moderate-intensity activity days; vigorous MET-minutes/week = 8.0 × vigorous-intensity activity minutes × vigorous-intensity activity days; total physical activity MET-minutes/week = walking + moderate + vigorous MET-minutes/week.	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of sleep quality	Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). The score ranges from 0 to 21 and the higher score indicates the higher sleep quality.	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Change of Quality of life (12-Item Short Form Survey, SF-12)	Quality of life will be measured by 12-Item Short Form Survey (SF-12). The score ranges from 0 to 100 and the higher score indicates the higher quality of life.	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Incidence of depression	Depression will be measured by 9-item Patient Health Questionnaire (PHQ-9). The score ranges from 0 to 27 and the higher score indicates higher level of depression. A score greater than 4 indicates depression.	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Incidence of anxiety	Anxiety will be measured by Zung's Self Rating Anxiety Scale (SAS). The score ranges from 25 to 100 and the higher score indicates higher level of anxiety. A score greater than 49 indicates anxiety.	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	The Change of Self-efficacy score (General Self-Efficacy Scale, GSES)	Self-efficacy will be measured by General Self-Efficacy Scale (GSES). The score ranged from 10 to 40 and the higher score indicates higher level of self-efficacy.	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	The stage of change related to gestational weight control behavior	The investigators will use two items to assess it. "Have the participants started to adjust their diet/physical activity to control their weight during pregnancy?", "No and I do not plan to do so in the next 6 months/No, but I am ready to start within the next 6 months/No, but I am ready to start in the next 30 days/Yes, but not regularly/Yes, I am currently controlling my weight by adjusting my diet/physical activity regularly, but it has not reached 6 months /Yes, I have been controlling my weight for more than 6 months by adjusting my diet/physical activity" choices will be provided.	From baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Other	Rate of Postpartum weight retention	Maternal postpartum weight will be obtained through routine physical examination or telephone follow-up.	42 days, 6 months, 1 year after delivery
Other	Absolute/mean offspring weight in kilograms	The difference between arms in offspring's weight.	42 days, 6 months and 1 year after birth.
Other	Absolute/mean offspring height in centimetres	The difference between arms in offspring's height.	42 days, 6 months and 1 year after birth.
Other	Absolute/mean offspring head circumference	The difference between arms in offspring's head circumference.	42 days, 6 months and 1 year after birth.
Primary	Total gestational weight gain	Weight at gestational week 32-36 minus pre-pregnancy weight (kilograms)	From pre-pregnancy to gestational week 32-36
Primary	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	Weekly rate of gestational weight gain between study clinical assessments	Gestational weight gain between pre-pregnancy/baseline (10-14 weeks) and midterm (24-28 weeks)/terminal (32-36 weeks) divided by the number of weeks (kilograms per week)	Gestational weight gain from pre-pregnancy/baseline (10-14 weeks) to midterm (24-28 weeks)/terminal (32-36 weeks)
Secondary	Proportion of women who exceed the Chinese reference/2009 IOM guidelines for total gestational weight gain	The percentage of women who gain more weight during pregnancy than the recommended guidelines set by either the Chinese reference or the 2009 Institute of Medicine (IOM) guidelines.	From pre-pregnancy to terminal (32-36 weeks)
Secondary	Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG in second and third trimester	The percentage of women who surpass the recommended weekly weight gain during the second and third trimesters according to either the Chinese reference or the 2009 IOM guidelines.	From baseline (10-14 weeks) to terminal (32-36 weeks)
Secondary	Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG before OGTT screening	The percentage of women who gain more weight than the recommended weight gain before OGTT screening that is whether weight gain during the first and second trimester or during the second trimester is beyond the recommendations.	From pre-pregnancy/baseline (10-14 weeks) to midterm (24-28 weeks)
Secondary	Rate of Gestational Diabetes Mellitus diagnosed according to International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria	Fasting plasma glucose (FPG) = 5.1 mmol/L, and/or 1-h blood glucose = 10.0 mmol/L, and/or 2-h blood glucose = 8.5 mmol/L	OGTT screening at 24-28 gestational weeks
Secondary	Rate of Preeclampsia/Gestational hypertension	Preeclampsia was defined according to the criteria of the American College of Obstetricians and Gynecologists (ACOG) i.e. systolic blood pressure of = 140 mmHg or diastolic blood pressure of = 90 mmHg occurring after 20 weeks of gestation in a previously normotensive woman combined with new-onset proteinuria of =0.3 g/24 h. Gestational hypertension was defined similarly but without the presence of proteinuria.	From 20 weeks of gestation to delivery
Secondary	Rate of Cesarean Section	Cesarean Section	At delivery
Secondary	Absolute/Mean Infant birth weight	Birth weight at delivery(kilograms)	At delivery
Secondary	Rate of Macrosomia	Infant birth weight of = 4000g	At delivery
Secondary	Absolute/Mean Apgar scores at 1 min or 5 min	Apgar scores at 1 min or 5 min evaluates the baby's heart rate, respiratory effort, muscle tone, reflex irritability, and color. Each category is scored from 0 to 2, and the total score ranges from 0 to 10. A higher Apgar score indicates that the newborn is in good health.	At delivery