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New treatment option for Gestational Weight Gain
Official title Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
ClinicalTrials.gov ID: NCT05807594
What this study is testing
- What it's testing
- The goal of this clinical trial is to see if the enhanced HMZ 2.0 intervention with new control system/digital platform to regulate gestational weight gain (GWG) and impact maternal-infant outcomes while collecting implementation data works and can be given to other pregnant women in various settings. The question this study aims to answer are: 1.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant women
- ≥ 8 and \< 18 weeks gestation at time of screening. This range of gestational age is chosen to: a) reduce chances of false pregnancy or miscarriage...
- Singleton gestation
- Not currently heavily smoking (\>20 cigarettes/day)
- Any parity (i.e., first-time pregnancy, second pregnancy, etc.)
You likely can't join if
- Not pregnant women
- Men (unable to become pregnant)
- Multiple gestation
- \ 18 weeks gestation at time of pre-intervention assessment
- Currently smoking \> 20 cigarettes/day
- Outside of the age range of 18-45 years
See the full eligibility criteria
- Pregnant women
- ≥ 8 and \< 18 weeks gestation at time of screening. This range of gestational age is chosen to: a) reduce chances of false pregnancy or miscarriage under 8 weeks gestation and b) recruit women in the 1st trimester for...
- Singleton gestation
- Not currently heavily smoking (\>20 cigarettes/day)
- Any parity (i.e., first-time pregnancy, second pregnancy, etc.)
- Any race/ethnicity
- Ages 18-45 years
- Body mass index (BMI) range 20.0 to 45.0. If BMI is over 40, consultation with woman's health care provider will be made to determine eligibility and ensure she does not have any contraindications to physical activity...
- Haven't exceeded 25% or more of their total GWG (based on BMI and IOM guidelines) from pre-pregnancy to date of enrollment.
- Participant has physician consent to confirm subject participation
- Able to read, understand, and speak English
- Access to a computer/phone
- Willingness and ability to complete study materials and intervention sessions electronically (e.g., email, Facetime, Zoom), at home (e.g., Zoom sessions delivered synchronous and asynchronous) or if requested by the...
- No current use of weight loss medications
- No current participation in another treatment study or program that influences weight control
- No planned bariatric surgery during this current pregnancy
- No absolute contraindications to exercise in pregnancy and relative contraindications with provider consent (see below)
- Not pregnant women
- Men (unable to become pregnant)
- Multiple gestation
- \ 18 weeks gestation at time of pre-intervention assessment
- Currently smoking \> 20 cigarettes/day
- Outside of the age range of 18-45 years
- Outside of the BMI range of 20.0-45.0
- Exceeded 25% of their total GWG (based on BMI and IOM guidelines) from pre-pregnancy to date of enrollment
- Not able to read and/or understand English
- Unable to access materials by computer or phone (even with data plan assistance if necessary)
- Current use of weight loss medications
- Current participation in another treatment study or program that influences weight control
- Planned bariatric surgery during this current pregnancy
- Contraindications to aerobic exercise in pregnancy: Absolute contraindications to exercise:
- Hemodynamically significant heart disease
- Restrictive lung disease (pulmonary fibrosis, sarcoidosis, pleural effusion, neuromuscular disease). This DOES NOT include ASTHMA
- Incompetent cervix/cerclage
- Severe anemia
- Multiple gestation at risk for premature labor
- Persistent 2nd or 3rd trimester bleeding
- Placenta previa after 26 weeks gestation
- Premature labor during the current pregnancy
- Ruptured membranes
- Poorly controlled chronic hypertension
- Preeclampsia diagnosis during current pregnancy
- Poorly controlled Type 1 diabetes Relative contraindications to exercise (if permission is not given by provider):
- Unevaluated maternal cardiac arrhythmia
- Chronic bronchitis
- Extreme morbid obesity (BMI \> 40.0; needs provider consent to participate)
- Extreme underweight (BMI \< 12.0)
- History of extremely sedentary lifestyle
- Current eating disorder(s) diagnosis
- Severe food allergies and/or dietary restrictions that may preclude study participation.
- Intrauterine growth restriction in current pregnancy
- Poorly controlled respiratory disorder (severe asthma) that precludes study participation
- Orthopedic limitations
- Poorly controlled seizure disorder
- Poorly controlled thyroid disease
- Uncontrolled sleep disorder (insomnia, sleep-disordered breathing)
The study team makes the final eligibility decision.
Where it's taking place
- University Park, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include University Park, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.