Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Not pregnant women

Men (unable to become pregnant)

Multiple gestation

< 8 weeks gestation or > 18 weeks gestation at time of pre-intervention assessment

Trial design

Design model

Parallel

Treatments tested in this trial

  • HMZ 2.0 Intervention

    Behavioral

    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

    Behavioral

    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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: HMZ 2.0 Intervention GroupExperimental treatment 1 intervention
Group B: Attention Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gestational Weight Gain and Weight Change

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).

Time frame
Measured daily at pre-post intervention and daily throughout the intervention study period (~6 months).
2

Physical Activity (PA) and Sedentary Behavior

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.

Time frame
Measured daily at pre-post intervention (Fitbit Charge 5 and ActiGraph) and daily (Fitbit Charge 5) throughout the intervention study period (~6 months).
3

Energy Intake (EI) Estimation (Back-Calculation of Energy Intake)

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.

Time frame
Measured at pre-post intervention and daily throughout the intervention study period (~6 months).

Secondary outcomes

1

Theory of Planned Behavior Constructs: Healthy Eating/Limit Unhealthy Eating Attitude, Subjective Norm, Perceived Behavioral Control, Intention

The Theory of Planned Behavior will inform our dynamical model in order to create individualized interventions for OW/OBPW. Beliefs: These items were developed to assess Theory of Planned Behavior (TPB) behavioral, control, and normative beliefs. Main Constructs: The Theory of Planned Behavior (TPB) Healthy Eating Main Constructs measure is a 38-item measure developed to assess the main constructs of the TPB (i.e., attitude, subjective norm (SN), perceived behavioral control (PBC), intention) as they relate tohealthy eating behavior. Scoring for the TPB is the sum of each subscale. Attitude and Limit Attitude range of scores: 7-49 - higher score means greater/more positive attitude; SN and Limit SN range: 3-21 - higher score greater/more positive subjective norm; PBC and Limit PBC range: 3-21 - higher score greater/more positive PBC; Intention range: 6-42 - higher score greater/more positive intention.

Time frame
Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).
2

Theory of Planned Behavior Constructs: Physical Activity Attitude, Subjective Norm, Perceived Behavioral Control, Intention

The Theory of Planned Behavior will inform our dynamical model in order to create individualized interventions for OW/OBPW. Beliefs: These items were developed to assess Theory of Planned Behavior (TPB) behavioral, control, and normative beliefs. Main Constructs: The Theory of Planned Behavior (TPB) Healthy Eating Main Constructs measure is a 38-item measure developed to assess the main constructs of the TPB (i.e., attitude, subjective norm (SN), perceived behavioral control (PBC), intention) as they relate to healthy eating behavior. Scoring for the TPB is the sum of each subscale. Attitude range of scores: 7-49 - higher score means greater/more positive attitude; SN range: 3-21 - higher score greater/more positive subjective norm; PBC range: 3-21 - higher score greater/more positive PBC; Intention range: 6-42 - higher score greater/more positive intention.

Time frame
Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).
3

Self-Regulation Healthy Eating Constructs: Prospective/ Retrospective Control, Action Planning

Self-regulation of HE will be measured in order to inform our dynamical model and to how well OW/OBPW are at regulating their energy intake and expenditure and how it impacts their GWG. These items were taken from Ryan Rhodes items for self-regulation of PA and adapted for HE behaviors. Ryan has indicated that these items work really well as an index for HE self-regulation because these behaviors are naturally inter-connected but to look at specific self-regulatory behaviors: self-monitoring, goal-setting, action planning, coping planning, scheduling, affective There are also 2 sets of 8 questions-first 8 examine prospective behaviors while the second set assesses retrospective behaviors. Retrospective scores range from 11-55 and Prospective scores range from 11-55. Total scores range from 22-110. A higher score indicates higher levels of HE self-regulation.

Time frame
Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).
4

Self-Regulation Physical Activity Constructs: Prospective/ Retrospective Control, Action Planning

Self-regulation of PA will be measured in order to inform our dynamical model and to how well OW/OBPW are at regulating their energy intake and expenditure and how it impacts their GWG. These items are taken from Ryan Rhodes. Ryan has indicated that these items work really well as an index because these behaviors are naturally inter-connected but to look at specific self-regulatory behaviors: Item #1: self-monitoring, Item #2: goal-setting, Item # 3: action planning, Item #4: coping planning, Item #5: scheduling, Item #6, 7, 8, 9: cuing, Items 10 \& 11: affective. There are also 2 sets of 8 questions-first 8 examine prospective behaviors while the second set assesses retrospective behaviors. Retrospective scores range from 11-55 and Prospective scores range from 11-55. Total scores for overall self-regulation range from 22-110. A higher score indicates higher levels of PA self-regulation.

Time frame
Measured at pre-post intervention, daily during the 10-day free-living period, and weekly throughout the intervention study period (~6 months).

Other outcomes

1

Clinical/Safety Protocol: Height

Height will be assessed with a stadiometer using standard procedures in the Penn State Clinical Research Center.

Time frame
Measured at pre-intervention
2

Clinical/Safety Protocol: Blood Pressure/Urine

Blood pressure and urine BP\>140/90, 1+ protein in urine) to will be measured/collected to (screen for preeclampsia at the Penn State Clinical Research Center.

Time frame
Measured at pre-intervention
3

Clinical/Safety Protocol: Socio-demographic Measures

Participants complete measures assessing general demographic information (e.g., age, pre-pregnancy BMI, race/ethnicity, marital status, family income, parity, medical history, smoking, drinking, other health-related behaviors, family health history, pregnancy history, and complications in any previous pregnancies they may have had that did go to full term.

Time frame
Measured at pre-intervention
4

Clinical/Safety Protocol: Center for Epidemiological Studies Depression Scale

The Center for Epidemiological Studies Depression (CES-D) scale is a 20-item self-report scale that is designed to measure current levels of depressive symptomology (with emphasis on the affective component, depressed mood) in the general population. Scores can range from 0-60. A score of 16 or higher is indicative of depressive symptoms. Women with scores of 16 or higher will be referred for follow-up with their provider (or given a referral as needed).

Time frame
Measured at pre-post intervention and monthly over the study for the safety protocol (~6 months)

Sponsors and contacts

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Penn State University

Lead sponsor

Arizona State University

Collaborator