Recruiting

Healthy Mom Zone

Sponsor:

Penn State University

Code:

NCT05807594

Conditions

Gestational Weight Gain

Overweight and Obesity

Pregnancy

Energy Balance

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

HMZ 2.0 Intervention

Attention Control Intervention

Study Details

Brief summary:

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. Does the new intervention manage GWG?
2. Does the new intervention have any influence on sleep and eating behaviors and infant outcomes.
3. Does the new platform and other data collected help inform how well the research and information can be used in health care settings?

144 pregnant women with overweight/obesity will be randomized to either the HMZ 2.0 intervention or attention control groups from \~8-36 weeks gestation. All participants will be asked to:

1. Weight themselves and wear an activity monitor each day over the study.
2. Complete online surveys at either a weekly or monthly level about their thoughts, attitudes, and behaviors on GWG, physical activity, eating behaviors, sleep, their anxiety, depression, and stress.
3. Attend weekly sessions with a registered dietician.

The weekly sessions will differ based on intervention group. The HMZ 2.0 intervention group will receive education, create and follow goal-setting and action plans, self-monitor their behaviors, and receive feature evidence and fetal growth facts. Education, goals, and self-monitoring will focus on GWG, physical activity, eating behaviors, sleep, self-regulating behaviors and emotions, and preparing for labor/delivery and postpartum.

The attention control group will receive weekly sessions on preparing for labor/delivery and benefits of behavioral pain management strategies (e.g., mindfulness-based relaxation, imagery, music, massage, deep-breathing) to help with pain after childbirth without medicine.

Conditions

Gestational Weight Gain

Overweight and Obesity

Pregnancy

Energy Balance

Study ID

NCT05807594

Start date

Nov 27, 2023

Status verified date

Jan, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion 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 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 Criteria:

  • 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:

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)

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: HMZ 2.0 Intervention Group

HMZ 2.0 will be delivered by a registered dietitian in weekly didactic, one-on-one discussions in remote synchronous format (e.g., Zoom). If a subject has internet connectivity issues, she will be able to participate in the remote sessions from an onsite location (e.g., laboratory space on the Penn State University Park campus, clinical space at Hershey campus or Geisinger). All intervention women will receive the baseline intervention delivered as a maximum of 24 weekly modules (depending on gestational age at enrollment) which includes: Education and Counseling (GWG/PA/EI/sedentary behaviors/sleep behaviors/stress management, etc.), Goal-Setting and Action Plans (guided and self-selected PA/EI goals including recipe and workout booklet use), Self-Monitoring (wearing/using mHealth tools to monitor GWG/PA/EI/sleep), and Featured Evidence and Fetal Growth Facts (evidence-based studies and baby growth fun facts shared with women about how mom's health impacts her baby).

active comparator: Attention Control Group

All women will receive prenatal care offered by recruitment sites with routine provider visits, prenatal counseling, brief discussions on healthy prenatal behaviors, and clinical oversight of health (e.g., monitor glucose levels if diagnosed with gestational diabetes during the study period). Women randomized to the attention control group will complete the same measurement procedures as the intervention group. To match the HMZ intervention group, women will receive weekly, remote-delivered education content (60 min/session) on preparing for labor/delivery and benefits of behavioral pain management strategies (e.g., mindfulness-based relaxation, imagery, music, massage, deep-breathing) to regulate pain after childbirth with non-pharmacological approaches. Content is drawn from evidence-based guidelines and materials designed by Dr. Downs and her team for a Patient-Provider Toolbox to reduce opioid-related pain management use after childbirth.

Interventions

HMZ 2.0 Intervention

The intervention may be adapted such that a woman receives more support with each adaptation (only women who need added support to regulate GWG will receive adaptation). The model-based predictive control system in the HMZ 2.0 digital platform will continually and automatically evaluate GWG, identify when a woman may exceed GWG guidelines, and recommend an adaptation. The registered dietitian will review the data and behavior strategies that are suggested (guided PA workouts, EI cooking demonstrations, customized grocery planning, portion size control, food scales, and meal replacements). Practical, easy-to-adopt examples will be provided (walking in 5-10 min increments throughout the day to increase PA kcal, reduce sitting by 5 min/hour; replace 8 oz of whole milk with skim milk to reduce EI kcal) to facilitate behavior change while adhering to safety standards. Each woman's unique preferences and past successes with strategies are also considered when personalizing the dosage.

Attention Control Intervention

Consistent with guidelines for comparator groups, all women will receive prenatal care offered by recruitment sites with routine provider visits, counseling about prenatal behaviors (e.g., no smoking), and clinical oversight of health. Women randomized to the attention control group will complete the same measurement procedures as the intervention group.

Primary outcome measure

  • Gestational Weight Gain and Weight Change [ Time Frame: Measured daily at pre-post intervention and daily throughout the intervention study period (~6 months). ]
  • Physical Activity (PA) and Sedentary Behavior [ Time Frame: Measured daily at pre-post intervention (Fitbit Charge 5 and ActiGraph) and daily (Fitbit Charge 5) throughout the intervention study period (~6 months). ]
  • Energy Intake (EI) Estimation (Back-Calculation of Energy Intake) [ Time Frame: Measured at pre-post intervention and daily throughout the intervention study period (~6 months). ]

Central Contacts and Locations

Central contacts

Abigail Pauley, PhD

814-865-0840amp34@psu.edu

Locations

Pennsylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

Abigail M Pauley, PhD

814-865-0840amp34@psu.edu

Principal Investigator:

Danielle Symons Downs, PhD

More Information

Sponsor

Penn State University

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-01-16.