Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0

NCT05807594 | Recruiting DMC

• 1 other identifier: 00019075
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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. 1.Does the new intervention manage GWG?
2. 2.Does the new intervention have any influence on sleep and eating behaviors and infant outcomes.
3. 3.Does the new platform and other data collected help inform how well the research and information can be used in health care settings?
4. 4.Weight themselves and wear an activity monitor each day over the study.
5. 5.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.
6. 6.Attend weekly sessions with a registered dietician.

Conditions

Energy Balance; Gestational Weight Gain; Overweight and Obesity; Pregnancy

Outcome Measures

Primary Outcomes (3)

• Gestational Weight Gain and Weight Change

  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).

  Measured daily at pre-post intervention and daily throughout the intervention study period (~6 months).

• Physical Activity (PA) and Sedentary Behavior

  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.

  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)

  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.

  Measured at pre-post intervention and daily throughout the intervention study period (~6 months).

Secondary Outcomes (18)

• Theory of Planned Behavior Constructs: Healthy Eating/Limit Unhealthy Eating Attitude, Subjective Norm, Perceived Behavioral Control, Intention

  Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).

• Theory of Planned Behavior Constructs: Physical Activity Attitude, Subjective Norm, Perceived Behavioral Control, Intention

  Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).

• Self-Regulation Healthy Eating Constructs: Prospective/ Retrospective Control, Action Planning

  Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).

• Self-Regulation Physical Activity Constructs: Prospective/ Retrospective Control, Action Planning

  Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).

• Resting Metabolic Rate

  Measured at pre- and -post intervention of the 6 month intervention study period.

Other Outcomes (4)

• Clinical/Safety Protocol: Height

  Measured at pre-intervention

• Clinical/Safety Protocol: Blood Pressure/Urine

  Measured at pre-intervention

• Clinical/Safety Protocol: Socio-demographic Measures

  Measured at pre-intervention

Study Arms (2)

HMZ 2.0 Intervention Group

EXPERIMENTAL

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).

Behavioral: HMZ 2.0 Intervention

Attention Control Group

ACTIVE COMPARATOR

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.

Behavioral: Attention Control Intervention

Interventions

HMZ 2.0 Intervention BEHAVIORAL

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.

HMZ 2.0 Intervention Group

Attention Control Intervention BEHAVIORAL

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.

Attention Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Penn State University: lead
• Arizona State University: collaborator

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

RECRUITING

Related Publications (4)

• Khan O, Campregher F, Rivera DE, Visioli A, Pauley AM, Downs DS. An Optimized Behavioral Intervention for Managing Gestational Weight Gain Using Semi-Physical Modeling and Hybrid Model Predictive Control. IEEE Int Conf Commun. 2025 Jul;2025:3317-3322. doi: 10.23919/ACC63710.2025.11107916. Epub 2025 Aug 21.

  PMID: 41306560 BACKGROUND

• Das JN, Ji L, Shen Y, Kumara S, Buxton OM, Chow SM. Performance evaluation of a machine learning-based methodology using dynamical features to detect nonwear intervals in actigraphy data in a free-living setting. Sleep Health. 2025 Apr;11(2):166-173. doi: 10.1016/j.sleh.2024.10.003. Epub 2025 Jan 9.

  PMID: 39788836 BACKGROUND

• Oh H, Hunter MD, Chow SM. Measurement Model Misspecification in Dynamic Structural Equation Models: Power, Reliability, and Other Considerations. Struct Equ Modeling. 2025;32(3):511-528. doi: 10.1080/10705511.2025.2452884. Epub 2025 Feb 13.

  PMID: 40556684 BACKGROUND

• Downs DS, Pauley AM, Rivera DE, Savage JS, Moore AM, Shao D, Chow SM, Lagoa C, Pauli JM, Khan O, Kunselman A. Healthy Mom Zone Adaptive Intervention With a Novel Control System and Digital Platform to Manage Gestational Weight Gain in Pregnant Women With Overweight or Obesity: Study Design and Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 13;14:e66637. doi: 10.2196/66637.

  PMID: 40080809 BACKGROUND

MeSH Terms

Conditions

Gestational Weight Gain; Overweight; Obesity

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Abigail Pauley, PhD

CONTACT

814-865-0840; amp34@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All investigators and the outcomes assessor(s) will be masked from the randomization scheme, and what study groups each participant will be/was randomized to. The randomization scheme will be developed and programmed into REDCap by the biostatistician. The team of investigators will not have knowledge of the randomization scheme or be able to view the programming. The programming will be password protected and only be able to be accessed by the biostatistician.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A staff member will request randomization after the pre-intervention measures by unique subject ID number. The study biostatistician will develop the randomization scheme using variable-size, random permuted blocks to ensure the number of subjects in each group is balanced after each set of B randomized subjects where B is block size. Randomization to control (n=72) and intervention (n=72) groups will use 1:1 allocation; subjects will be entered consecutively. Randomization will be stratified by pre-pregnancy BMI status (\< 29.9 kg/m2 vs. greater than or equal to 30 kg/m2). A staff member will call each woman to inform her of study assignment and schedule her for the first session (attention control or HMZ 2.0 intervention).

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 11, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)