Clinical trial NCT05807594: Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
Official title: Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems Methodology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Weight Gain
Overweight and Obesity
Pregnancy
Energy Balance
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2023-04-11
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed description: Pre-intervention: Onsite procedures. Pregnant women with overweight/obesity enrolled in the study will be asked to complete assessments (≥8 and \<18 weeks gestation) at the Penn State Clinical Research Center (University Park or Hershey campus) or at home via Zoom. A study staff member will describe the study and obtain consent. Women with any health issues will be asked to follow-up with their provider and/or given a referral as needed. Subjects will have access to REDCap (Research Electronic Data Capture), a secure, web-based application to complete online surveys for social cognitive outcomes for PA and EI (eating healthy/ limiting unhealthy foods), and sleep and eating behaviors. A staff member will answer questions and explain the free-living procedures. This visit will take \~90 minutes.

Pre-intervention: Free-living procedures. A 10-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 10-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).

Eligibility criteria: 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
* 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
* 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 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
* 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)

Primary outcomes:
measure: Gestational Weight Gain and Weight Change
timeFrame: Measured daily at pre-post intervention and daily throughout the intervention study period (~6 months).
measure: Physical Activity (PA) and Sedentary Behavior
timeFrame: Measured daily at pre-post intervention (Fitbit Charge 5 and ActiGraph) and daily (Fitbit Charge 5) throughout the intervention study period (~6 months).
measure: Energy Intake (EI) Estimation (Back-Calculation of Energy Intake)
timeFrame: Measured at pre-post intervention and daily throughout the intervention study period (~6 months).
Secondary outcomes:
measure: Theory of Planned Behavior Constructs: Healthy Eating/Limit Unhealthy Eating Attitude, Subjective Norm, Perceived Behavioral Control, Intention
timeFrame: Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).
measure: Theory of Planned Behavior Constructs: Physical Activity Attitude, Subjective Norm, Perceived Behavioral Control, Intention
timeFrame: Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).
measure: Self-Regulation Healthy Eating Constructs: Prospective/ Retrospective Control, Action Planning
timeFrame: Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).
measure: Self-Regulation Physical Activity Constructs: Prospective/ Retrospective Control, Action Planning
timeFrame: Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).
measure: Resting Metabolic Rate
timeFrame: Measured at pre- and -post intervention of the 6 month intervention study period.
measure: Diet Quality
timeFrame: Measured at pre-post intervention and weekly (3 days/week) throughout the intervention study period (~6 months).
measure: Pittsburgh Sleep Quality Index
timeFrame: Measured once at pre-post intervention and monthly throughout the intervention study period (~6 months)
measure: Sleep Behaviors - FitBit Charge 5 Activity Monitor
timeFrame: Measured daily at pre-post intervention and daily throughout the intervention study period (~6 months).
measure: PROMIS Sleep Disturbance Short Form
timeFrame: Measured daily at pre-post intervention and daily throughout the study period (~6 months)
measure: Activity and Sleep Logs
timeFrame: Measured daily at pre-post intervention and daily throughout the study (~6 months)
measure: Three Factor Eating Questionnaire
timeFrame: Measured once at pre-post intervention and monthly throughout the intervention study period (~6 months)
measure: Infant Birth Outcomes
timeFrame: Measured at delivery of child. Data will be retrieved from medical records.
measure: Maternal-Infant Labor/Delivery and Adverse Pregnancy Outcomes
timeFrame: Measured at labor/delivery. Data will be retrieved from medical records.
measure: Implementation Markers: Subject engagement/participation and acceptability
timeFrame: Through study completion, approximately 6 months
measure: Implementation Markers: Subject Facilitators and Barriers
timeFrame: Measured at post-intervention, approximately at 34-37 weeks gestation
measure: Implementation Markers: Clinician Stakeholder Facilitators and Barriers
timeFrame: Measured at study completion and once all participants have completed the study, which could be roughly 2 years after start of study
measure: Implementation Markers: Staff engagement, burden
timeFrame: Through study completion, approximately 6 months
measure: Implementation Markers: Dosage exposure
timeFrame: Through study completion, approximately 6 months
Other outcomes:
measure: Clinical/Safety Protocol: Height
timeFrame: Measured at pre-intervention
measure: Clinical/Safety Protocol: Blood Pressure/Urine
timeFrame: Measured at pre-intervention
measure: Clinical/Safety Protocol: Socio-demographic Measures
timeFrame: Measured at pre-intervention
measure: Clinical/Safety Protocol: Center for Epidemiological Studies Depression Scale
timeFrame: Measured at pre-post intervention and monthly over the study for the safety protocol (~6 months)
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
References: