Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
NCT ID: NCT05807594
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2023-11-27
2028-01-31
Brief Summary
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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.
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Detailed Description
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Pre-intervention: Free-living procedures. A 7-9-day period will provide a grounding of each subject's baseline physical activity (including sedentary behavior), energy intake, social cognitive determinants, and sleep/eating behaviors for the individual energy balance model to predict GWG. Energy intake kcal will be estimated with the back-calculation method utilizing measured weight, physical activity, and resting metabolic rate (quadratic regression formula). There is not a set threshold of data compliance for back-calculating energy intake, the investigators will use strategies to reach similar compliance (\>90%) as our feasibility trial and other studies that used a run-in phase. Only women with no weight or physical activity data during this period will be excluded. On the morning of each day of the 7-9-day free-living protocol, subjects will be asked to complete study measures. The investigators will prompt with daily reminders and follow-up with non-compliant women to resolve barriers/technology issues.
Measurement procedures over study period. Subjects will use mHealth tools for real-time data collection on our energy balance and behavior model constructs to predict GWG in the Control Optimization Trial and assess sleep/eating behaviors. Data collection will occur: daily for GWG and physical activity/sedentary behavior/sleep; weekly for physical activity/energy intake social cognitive determinants (online in REDCap), and on at least 2 weekdays/1 weekend for energy intake diet quality. Monthly measures of eating behaviors and psychosocial health will be assessed.
Post-intervention assessments. Maternal GWG, physical activity, sedentary behavior, energy intake, social cognitive determinants, and sleep/eating behaviors will be obtained with the same mHealth devices/procedures as described above in the pre-intervention assessments. To reduce subject burden, there will be no onsite post-assessments.
Labor and delivery data will be abstracted from the medical record with patient HIPAA authorization.
Randomization. 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 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. ≥ 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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).
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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)
18 Years
45 Years
FEMALE
Yes
Sponsors
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Arizona State University
OTHER
Penn State University
OTHER
Responsible Party
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Danielle Downs
Professor
Locations
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Pennsylvania State University
University Park, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Gray NW, Fourgeaud L, Huang B, Chen J, Cao H, Oswald BJ, Hemar A, McNiven MA. Dynamin 3 is a component of the postsynapse, where it interacts with mGluR5 and Homer. Curr Biol. 2003 Mar 18;13(6):510-5. doi: 10.1016/s0960-9822(03)00136-2.
Garcia Compean D. [Treatment of acute hepatitis C]. Rev Gastroenterol Mex. 2002 Oct;67 Suppl 2:S61-6. Spanish.
Badon LA, Hicks A, Lord K, Ogden BA, Meleg-Smith S, Varner KJ. Changes in cardiovascular responsiveness and cardiotoxicity elicited during binge administration of Ecstasy. J Pharmacol Exp Ther. 2002 Sep;302(3):898-907. doi: 10.1124/jpet.302.3.898.
Calabresi L, Gomaraschi M, Villa B, Omoboni L, Dmitrieff C, Franceschini G. Elevated soluble cellular adhesion molecules in subjects with low HDL-cholesterol. Arterioscler Thromb Vasc Biol. 2002 Apr 1;22(4):656-61. doi: 10.1161/hq0402.105901.
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.
Other Identifiers
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00019075
Identifier Type: -
Identifier Source: org_study_id
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