RECRUITING

Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0

Conditions

Gestational Weight Gain Overweight and Obesity Pregnancy Energy Balance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-27

Study Completion:2028-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05807594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 * Any parity (i.e., first-time pregnancy, second pregnancy, etc.) * Any race/ethnicity * Ages 18-45 years \[based on our pilot data this group comprises more than 85% of the live births in Central Pennsylvania\] * Overweight or obese: body mass index (BMI) range 24.0 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 * Residing in the United States * 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. * Not currently smoking * No severe allergies/dietary restrictions/eating disorders that may preclude study participation * No diagnosed insomnia * No absolute contraindications to exercise in pregnancy and relative contraindications with provider consent (see below)	* Not pregnant women * Men (unable to become pregnant) * Multiple gestation * \< 8 weeks gestation or \> 18 weeks gestation at time of pre-intervention assessment * Outside of the age range of 18-45 years * Outside of the BMI range of 24.0-45.0 * 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 * Not residing in the United States * Unable to access materials by computer or phone (even with data plan assistance if necessary) * Currently smoking * Pre-existing diabetes * Diagnosed insomnia (women will self-report their insomnia) * Pre-existing eating disorders. Women will self-report their eating disorder diagnosis history and the study team will check their electronic health record data/confirm with physician. * Severe allergies and dietary restrictions that may preclude study participation. * Contraindications to aerobic exercise in pregnancy:

Inclusion Criteria

Exclusion 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
* Any parity (i.e., first-time pregnancy, second pregnancy, etc.)
* Any race/ethnicity
* Ages 18-45 years \[based on our pilot data this group comprises more than 85% of the live births in Central Pennsylvania\]
* Overweight or obese: body mass index (BMI) range 24.0 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
* Residing in the United States
* 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.
* Not currently smoking
* No severe allergies/dietary restrictions/eating disorders that may preclude study participation
* No diagnosed insomnia
* No absolute contraindications to exercise in pregnancy and relative contraindications with provider consent (see below)

* Not pregnant women
* Men (unable to become pregnant)
* Multiple gestation
* \< 8 weeks gestation or \> 18 weeks gestation at time of pre-intervention assessment
* Outside of the age range of 18-45 years
* Outside of the BMI range of 24.0-45.0
* 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
* Not residing in the United States
* Unable to access materials by computer or phone (even with data plan assistance if necessary)
* Currently smoking
* Pre-existing diabetes
* Diagnosed insomnia (women will self-report their insomnia)
* Pre-existing eating disorders. Women will self-report their eating disorder diagnosis history and the study team will check their electronic health record data/confirm with physician.
* Severe allergies and dietary restrictions that may preclude study participation.
* Contraindications to aerobic exercise in pregnancy:

Contacts and Locations

Study Contact

Abigail Pauley, PhD

CONTACT

814-865-0848

amp34@psu.edu

Study Locations (Sites)

Pennsylvania State University

University Park, Pennsylvania, 16802

United States

Collaborators and Investigators

Sponsor: Penn State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27

Study Completion Date2028-01-31

Study Record Updates

Study Start Date2023-11-27

Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

Gestational Weight Gain
Overweight and Obesity
Pregnancy
Energy Balance