Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0

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.

Conditions

• Gestational Weight Gain
• Overweight and Obesity
• Pregnancy
• Energy Balance

Interventions

BEHAVIORAL

HMZ 2.0 Intervention

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.

BEHAVIORAL

Attention Control Intervention

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.

Sponsors & Collaborators

• Arizona State University

  collaborator OTHER

• Penn State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-27

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• United States

Study Locations