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Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0

This study is testing an enhanced program called HMZ 2.0 to help pregnant women manage their weight gain during pregnancy. It compares HMZ 2.0 to standard prenatal care. The goal is to see if HMZ 2.0 can effectively control gestational weight gain (GWG), influence sleep and eating habits, and impact infant health. Researchers also want to understand how well this program could be used in regular healthcare settings. You might be able to join if you are a pregnant woman between 18 and 45 years old, are 8 to less than 18 weeks pregnant, and are considered overweight or obese. The study will measure your weight, physical activity, and how much you eat daily for about six months to see if the intervention is successful.

Study design
This interventional study plans to enroll 144 pregnant women. Participants will be randomly assigned to either the HMZ 2.0 intervention group or a control group receiving standard prenatal care.
What's involved
You will complete assessments at a research center or via Zoom, which takes about 90 minutes. You will also track your physical activity, eating habits, and sleep daily for about six months.
Compensation
Not stated in the trial record.
Follow-up
Your weight, physical activity, and energy intake will be measured daily throughout the intervention period, which is approximately six months.

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NCT05807594

Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0

Recruiting
NAAges 18–45InterventionalPrevention
Penn State University
~144 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:HMZ 2.0 InterventionAttention Control Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gestational Weight Gain and Weight Change
Measured over Measured daily at pre-post intervention and daily throughout the intervention study period (~6 months).
+2 more outcomes measured

Conditions

Gestational Weight Gain
Overweight and Obesity
Pregnancy
Energy Balance

Explore related trials

ObesityPregnancy

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Abigail Pauley, PhD
[email protected]
814-865-0840
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 greatest impact of the intervention on gestational weight gain. In the feasibility and initial impact study, the investigators had less than 10% (n=3) miscarriages prior to randomization using these criteria
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 or other concerns with intervention participation.
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 participant, on-site at Penn State University Park or Hershey campuses.
No current use of weight loss medications
No current participation in another interventional 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)

Exclusion

Not pregnant women
Men (unable to become pregnant)
Multiple gestation
\< 8 weeks gestation or \> 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 interventional study or program that influences weight control
Planned bariatric surgery during this current pregnancy
Contraindications to aerobic exercise in pregnancy:
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
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)

What this trial measures

  • Gestational Weight Gain and Weight ChangeMeasured daily at pre-post intervention and daily throughout the intervention study period (~6 months).

    Weight and GWG will be assessed daily at home using the FitBit Aria Air Smart Scale (weights will be uploaded to online program via Bluetooth). GWG will be standardized: target weight gain will be determined for each woman based on BMI status (OW = 15-25 lb., OB = 11-20 lb.). For the criterion measure to determine when to adapt the intervention, weight gain will be calculated to determine if a woman is gaining \< her goal (-), at the exact amount of her goal (0), or \> her goal (+). Pre-pregnancy weight and GWG from the first prenatal visit to the last pre-delivery weight will also be obtained from clinical records. Weight will also be assessed at the Penn State Clinical Research Center using standard procedures (measured in duplicate to nearest kg using a high precision stand-on adult scale).

  • Physical Activity (PA) and Sedentary BehaviorMeasured daily at pre-post intervention (Fitbit Charge 5 and ActiGraph) and daily (Fitbit Charge 5) throughout the intervention study period (~6 months).

    Women will wear the wrist-worn Fitbit Charge 5 (Fitbit Inc., San Francisco, CA) 24 hours/day from the pre-intervention assessment until the end of the post-intervention assessment. The Fitbit Charge 5 will be used for continuous PA measure for our energy balance model to predict GWG. It will measure activity kcal, steps, minutes in sedentary/light/moderate PA. The waist-mounted ActiGraph GT3X will be worn at pre- and post-intervention during waking hours to assess PA and sedentary behavior (activity kcal, steps, minutes in sedentary/light/moderate PA). While the ActiGraph is considered a "gold standard" PA measure, our pilot data showed high burden for PW-OW/OB to wear it continuously; thus, it will be used as a pre-post intervention PA measure only.

  • Energy Intake (EI) Estimation (Back-Calculation of Energy Intake)Measured at pre-post intervention and daily throughout the intervention study period (~6 months).

    Self-report EI measures under-estimate EI by 35-59%; EI under-reporting is common in people with obesity and especially in PW-OW/OB. Because our energy balance model relies on accurate EI/PA estimates to predict GWG (and our PA/weight measures provide accurate estimates), EI under-reporting compromises the prediction. EI is estimated from measured W (Aria Wi-Fi scale), PA (Fitbit Charge 5 activity monitor), and resting metabolic rate (RMR; Breezing mobile metabolism device) with k=1, 2,… N relating to day 1- day N. T is the sampling time (T=1 day). The noise in W is small relative to the total W, but the extent of this noise can affect the calculated rate of GWG/day, so a 5-day moving average filter is used to preprocess (smooth) measured W before "true" daily EI is estimated.