Evidence mapPaperPMID 40080809Full record

ArticleJMIR research protocols2025

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.

Danielle Symons Downs, Abigail M Pauley, Daniel E Rivera, Jennifer S Savage, Amy M Moore, Danying Shao, Sy-Miin Chow, Constantino Lagoa, Jaimey M Pauli, Owais Khan and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05807594 (Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems Methodology), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05807594 narecruitingnot on this map

Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems Methodology

TypeinterventionalSponsorPenn State UniversityRan2023 to 2028Enrolled144ConditionsGestational Weight Gain, Overweight and Obesity, Pregnancy, Energy BalanceArmsHMZ 2.0 Intervention, Attention Control Intervention
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Danielle Symons DownsDepartment of Kinesiology, Pennsylvania State University, University Park, PA, United States.ORCID 0000-0003-1294-9742
Abigail M PauleyDepartment of Kinesiology, Pennsylvania State University, University Park, PA, United States.ORCID 0000-0003-0644-0181
Daniel E RiveraSchool of Engineering of Matter, Transport and Energy, Arizona State University, Tempe, AZ, United States.ORCID 0000-0002-3141-0577
Jennifer S SavageDepartment of Nutrition, Center for Childhood Obesity Research, Pennsylvania State University, University Park, PA, United States.ORCID 0000-0002-2912-8687
Amy M MooreDepartment of Nutrition, Center for Childhood Obesity Research, Pennsylvania State University, University Park, PA, United States.ORCID 0000-0001-6935-2379
Danying ShaoInstitute for Computational and Data Sciences, Pennsylvania State University, University Park, PA, United States.ORCID 0000-0002-1920-3081
Sy-Miin ChowHuman Development and Family Studies, Quantitative Developmental Systems Methodology Core, Pennsylvania State University, University Park, PA, United States.ORCID 0000-0003-1938-027X
Constantino LagoaCollege of Engineering, School of Electrical Engineering and Computer Science, Pennsylvania State University, University Park, PA, United States.ORCID 0000-0001-6871-3240
Jaimey M PauliDivision of Maternal Fetal Medicine, College of Medicine, Pennsylvania State University, Hershey, PA, United States.ORCID 0000-0003-2089-4155
Owais KhanSchool of Engineering of Matter, Transport and Energy, Arizona State University, Tempe, AZ, United States.ORCID 0009-0008-2885-5752
Allen KunselmanDepartment of Public Health Services, Division of Biostatistics and Bioinformatics, College of Medicine, Pennsylvania State University, Hershey, PA, United States.ORCID 0000-0001-8485-2953

Funding

Penn State Clinical and Translational Science InstituteUL1TR002014 · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · 2025 to 2025
$3.8M
Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems MethodologyR01DK134863 · NIDDK · PENNSYLVANIA STATE UNIVERSITY, THE · 2023 to 2025
$2.0M
NCATS NIH HHS UL1 TR000127NCATS NIH HHS UL1 TR002014NHLBI NIH HHS R01 HL119245NHLBI NIH HHS R56 HL126799NIDA NIH HHS K25 DA021173NIDA NIH HHS R21 DA024266NIDDK NIH HHS R01 DK134863
6 · The paper itself

Abstract

backgroundRegulating gestational weight gain (GWG) in pregnant women with overweight or obesity is difficult, particularly because of the narrow range of recommended GWG for optimal health outcomes. Given that many pregnant women show excessive GWG and considering the lack of a "gold standard" intervention to manage GWG, there is a timely need for effective and efficient approaches to regulate GWG. We have enhanced the Healthy Mom Zone (HMZ) 2.0 intervention with a novel digital platform, automated dosage changes, and personalized strategies to regulate GWG, and our pilot study demonstrated successful recruitment, compliance, and utility of our new control system and digital platform.

objectiveThe goal of this paper is to describe the study protocol for a randomized controlled optimization trial to examine the efficacy of the enhanced HMZ 2.0 intervention with the new automated control system and digital platform to regulate GWG and influence secondary maternal and infant outcomes while collecting implementation data to inform future scalability.

methodsThis is an efficacy study using a randomized controlled trial design. HMZ 2.0 is a multidosage, theoretically based, and individually tailored adaptive intervention that is delivered through a novel digital platform with an automated link of participant data to a new model-based predictive control algorithm to predict GWG. Our new control system computes individual dosage changes and produces personalized physical activity (PA) and energy intake (EI) strategies to deliver just-in-time dosage change recommendations to regulate GWG. Participants are 144 pregnant women with overweight or obesity randomized to an intervention (n=72) or attention control (n=72) group, stratified by prepregnancy BMI (<29.9 vs ≥30 kg/m

resultsRecruitment started in April 2024, and enrollment will continue through May 2027. The primary (GWG) and secondary (eg, maternal and infant health) outcome results will be analyzed, posted on ClinicalTrials.gov, and published after January 2028.

conclusionsExamining the efficacy of the novel HMZ 2.0 intervention in terms of GWG and secondary outcomes expands the boundaries of current GWG interventions and has high clinical and public health impact. There is excellent potential to further refine HMZ 2.0 to scale-up use of the novel digital platform by clinicians as an adjunct treatment in prenatal care to regulate GWG in all pregnant women. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66637.

Indexed as

Gestational Weight GainObesityOverweightPregnancy ComplicationsAdultFemaleHumansPilot ProjectsPregnancyPregnant PeopleRandomized Controlled Trials as Topicgestational weight gainhealthy eatinginterventionobesityoverweightphysical activitypregnancy

Identifiers

PMID40080809
PMCPMC11950706

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.