Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems Methodology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Gestational Weight Gain and Weight Change
研究概览
简要总结
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:
- Does the new intervention manage GWG?
- Does the new intervention have any influence on sleep and eating behaviors and infant outcomes.
- 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:
- Weight themselves and wear an activity monitor each day over the study.
- 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.
- 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.
详细描述
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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
- •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)
排除标准
- •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:
- •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)
研究组 & 干预措施
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).
干预措施: HMZ 2.0 Intervention (Behavioral)
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.
干预措施: Attention Control Intervention (Behavioral)
结局指标
主要结局
Gestational Weight Gain and Weight Change
时间窗: Measured daily at pre-post intervention and daily throughout the intervention study period (~6 months).
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).
Physical Activity (PA) and Sedentary Behavior
时间窗: Measured daily at pre-post intervention (Fitbit Charge 5 and ActiGraph) and daily (Fitbit Charge 5) throughout the intervention study period (~6 months).
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.
Energy Intake (EI) Estimation (Back-Calculation of Energy Intake)
时间窗: Measured at pre-post intervention and daily throughout the intervention study period (~6 months).
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.
次要结局
- 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).)
- Activity and Sleep Logs(Measured daily at pre-post intervention and daily throughout the study (~6 months))
- Pittsburgh Sleep Quality Index(Measured once at pre-post intervention and monthly throughout the intervention study period (~6 months))
- Sleep Behaviors - FitBit Charge 5 Activity Monitor(Measured daily at pre-post intervention and daily throughout the intervention study period (~6 months).)
- PROMIS Sleep Disturbance Short Form(Measured daily at pre-post intervention and daily throughout the 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.)
- Diet Quality(Measured at pre-post intervention and weekly (3 days/week) throughout the intervention study period (~6 months).)
- Three Factor Eating Questionnaire(Measured once at pre-post intervention and monthly throughout the intervention study period (~6 months))
- Infant Birth Outcomes(Measured at delivery of child. Data will be retrieved from medical records.)
- Maternal-Infant Labor/Delivery and Adverse Pregnancy Outcomes(Measured at labor/delivery. Data will be retrieved from medical records.)
- Implementation Markers: Subject engagement/participation and acceptability(Through study completion, approximately 6 months)
- Implementation Markers: Subject Facilitators and Barriers(Measured at post-intervention, approximately at 34-37 weeks gestation)
- Implementation Markers: Clinician Stakeholder Facilitators and Barriers(Measured at study completion and once all participants have completed the study, which could be roughly 2 years after start of study)
- Implementation Markers: Dosage exposure(Through study completion, approximately 6 months)
- Implementation Markers: Staff engagement, burden(Through study completion, approximately 6 months)
研究者
Danielle Downs
Professor
Penn State University