Gestational Weight GainNCT06370533
Healthy Gestational Weight Gain Programme
A study testing behavioral interventions in people with Gestational Weight Gain and Overweight and Obesity, run by Peking University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Weight Gain, Overweight and Obesity
- What is being tested?
- behavioral interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 19 Apr 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
- 18-40 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Tongzhou Maternal and Child Health-care Institution
Beijing, Beijing Municipality
W.F. Maternal and Child Health Hospital；
Weifang, Shandong
About this study
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
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.
Read the detailed 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 obese 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 obese 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 scarce. 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 behavior 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 Wristband or WeChat Public Account. Tailoring of the intervention will be guided by the transtheoretical model. A total of 200 overweight or obese singleton pregnant women of 8-14 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 8-14 weeks (baseline),24-28 weeks (midterm) and 32-36 weeks (terminal) 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., will be collected from routine physical examination in 42 days, 6 months and 12 months of age.
- Conditions
- Gestational Weight Gain, Overweight and Obesity
- Being tested
- behavioral interventions
- Medical subject headings
- Gestational Weight Gain, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: behavioral interventions |
| usual-care control | No intervention | Provision of usual prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total gestational weight gain
Weight at gestational week 32-36 minus pre-pregnancy weight (kilograms)
Measured: 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)
Measured: From pre-pregnancy to midterm (24-28 weeks)
Secondary outcomes (8)
Weekly rate of gestational weight gain between study clinical assessments
Gestational weight gain between pre-pregnancy/baseline (8-14 weeks) and midterm (24-28 weeks)/terminal (32-36 weeks) divided by the number of weeks (kilograms per week)
Measured: 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
Exceeding the weekly rate of gestational weight gain according to Institute of Medicine guidelines was defined as being above the sum of the upper limit for the first trimester (2.0 kg)+upper limit for the weekly rate (0.33 kg for overweight, 0.27 kg for obesity) ×number of weeks in the second and/or third trimesters (ie, up until the last measured pregnancy weight).
Measured: 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
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
Measured: OGTT screening at 24-28 gestational weeks
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.
Measured: From 20 weeks of gestation to delivery
Rate of Cesarean Section
Cesarean Section
Measured: At delivery
Absolute/Mean Infant birth weight
Birth weight at delivery（kilograms）
Measured: At delivery
Rate of Macrosomia
Infant birth weight of ≥ 4000g
Measured: At delivery
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.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start19 Apr 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Health Science Center, W.F. Maternal and Child Health Hospital, Tongzhou Maternal and Child Health-care Institution of Beijing
- Responsible party
- Sponsor
- Investigators
- Haixue Wang, Doctor, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370533
- Sponsor's protocol ID
- HGWG-pro
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06370533
- Acronym / sponsor ID
- HGWG-pro
- Conditions
- Gestational Weight Gain, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University Health Science Center, W.F. Maternal and Child Health Hospital, Tongzhou Maternal and Child Health-care Institution of Beijing
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 obese 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 obese 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 scarce. 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 behavior 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 Wristband or WeChat Public Account. Tailoring of the intervention will be guided by the transtheoretical model. A total of 200 overweight or obese singleton pregnant women of 8-14 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 8-14 weeks (baseline),24-28 weeks (midterm) and 32-36 weeks (terminal) 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., will be collected from routine physical examination in 42 days, 6 months and 12 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Experimental | Behavioral: behavioral interventionsHealth 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. |
| usual-care control | No intervention | –Provision of usual prenatal care |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
- 18-40 years of age
- Singleton pregnant
- Skilled at using smartphones and WeChat during pregnancy
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral interventionsThe 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. | Behavioural | lifestyle intervention |
Primary outcome
Total gestational weight gain
Time frame: From pre-pregnancy to gestational week 32-36
Weight at gestational week 32-36 minus pre-pregnancy weight (kilograms)
Gestational weight gain before OGTT screening
Time frame: From pre-pregnancy to midterm (24-28 weeks)
Gestational weight gain before OGTT screening at 24-28 weeks (kilograms)
8 secondary outcomes
Weekly rate of gestational weight gain between study clinical assessments
Time frame: 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
Time frame: 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
Time frame: OGTT screening at 24-28 gestational weeks
Rate of Preeclampsia/Gestational hypertension
Time frame: From 20 weeks of gestation to delivery
Rate of Cesarean Section
Time frame: At delivery
Absolute/Mean Infant birth weight
Time frame: At delivery
Rate of Macrosomia
Time frame: At delivery
Absolute/Mean Apgar scores at 1 min or 5 min
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haixue Wang, Doctor principal investigator
Peking University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral interventions in people with Gestational Weight Gain and Overweight and Obesity, run by Peking University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total gestational weight gain (time frame: From pre-pregnancy to gestational week 32-36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.