HMZ 2.0 Intervention for Pregnancy Weight Management

(HMZ Two Trial)

Overseen By Abigail Pauley, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Penn State University

Must not be taking: Weight loss medications

Disqualifiers: Multiple gestation, Smoking, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

Duration: 6 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be using weight loss medications to participate.

Is the HMZ 2.0 Intervention for Pregnancy Weight Management safe for humans?

The studies reviewed focus on managing gestational weight gain through behavioral and educational interventions, which are generally considered safe for pregnant women. These interventions include providing information, motivational interviewing, and self-monitoring, all of which are non-invasive and have been associated with positive outcomes in managing weight gain during pregnancy. ^{1 2 3 4 5}

How does the HMZ 2.0 Intervention for Pregnancy Weight Management differ from other treatments?

The HMZ 2.0 Intervention is unique because it combines behavioral strategies with adaptive dosages to manage gestational weight gain, focusing on personalized education and counseling sessions. It also uses mHealth tools for daily monitoring, which helps tailor the intervention to individual needs, unlike standard treatments that may not offer such personalized and technology-driven approaches. ^{1 4 6 7 8}

What data supports the effectiveness of the HMZ 2.0 Intervention for Pregnancy Weight Management treatment?

The research on psychological strategies and cognitive-behavioral methods for pain management suggests that increasing perceived control and using cognitive coping skills can be beneficial. These elements, which are part of the HMZ 2.0 Intervention, may help manage weight during pregnancy by promoting healthier behaviors and improving self-management. ^{9 10 11 12 13}

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-45, with a BMI of 25.0 to 45.0, living in specific areas of Pennsylvania. They must be at 8-15 weeks gestation and have their doctor's consent to participate. Women over a BMI of 40 will need extra checks from their healthcare provider.

Inclusion Criteria

I am between 8 and 15 weeks pregnant.

All races and ethnicities are welcome to participate.

My BMI is between 25.0 and 45.0.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Pre-intervention

Participants complete assessments and a 10-day free-living period to establish baseline data

2-4 weeks

1 visit (in-person or virtual) and daily self-assessments

Treatment

Participants engage in weekly sessions with a registered dietitian and daily self-monitoring using mHealth tools

6 months

24 weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control Intervention
• HMZ 2.0 Intervention

Trial Overview The study tests the HMZ 2.0 intervention against an attention control group to manage weight during pregnancy and improve mother-infant outcomes using daily self-monitoring and weekly sessions with dieticians versus pain management education.

How Is the Trial Designed?

Group I: HMZ 2.0 Intervention Group Experimental Treatment 1 Intervention

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).

Group II: Attention Control Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Published Research Related to This Trial

A pain self-management program combining Cognitive Behavioural Therapy (CBT) and physical exercise (PE) over 10 weeks showed significant improvements in pain experience, depression, anxiety, and overall health in 214 out of 311 participants.

The program effectively addressed complex pain by incorporating education, cognitive skills, exercise, and self-management strategies, demonstrating that multimodal approaches can enhance pain management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from 10 Years of a CBT Pain Self-Management Outpatient Program for Complex Chronic Conditions. Boschen, KA., Robinson, E., Campbell, KA., et al.[2018]

A randomized trial involving 66 adolescents with chronic noncancer pain found that attention bias modification (ABM) training did not significantly change attention bias or improve pain-related outcomes compared to placebo or no training.

The study concluded that ABM training was ineffective in enhancing pain management or reducing symptoms of pain, anxiety, and depression in the participants, indicating that this approach may not be beneficial for adolescents with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention bias modification training for adolescents with chronic pain: a randomized placebo-controlled trial. Heathcote, LC., Jacobs, K., Van Ryckeghem, DML., et al.[2021]

Cognitive and cognitive-behavioral methods for pain control, such as coping strategies and preparatory information, show some promising but limited efficacy in clinical settings, based on a review of controlled studies.

Despite laboratory research on the psychological aspects of these methods, there is a significant lack of robust evidence supporting their effectiveness for managing clinical pain, highlighting the need for more thorough evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and cognitive-behavioral methods for pain control: a selective review. Tan, SY.[2022]

An 8-week Mindfulness-Oriented Recovery Enhancement (MORE) intervention significantly reduced pain attentional bias (AB) in chronic pain patients, indicating its potential effectiveness in managing chronic pain-related stimuli.

Participants in the MORE group reported increased perceived control over their pain and reduced emotional distress, suggesting that mindfulness practices can positively influence psychological factors associated with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-oriented recovery enhancement reduces pain attentional bias in chronic pain patients. Garland, EL., Howard, MO.[2013]

Psychological strategies, such as distraction, relaxation, and hypnosis, can effectively help manage acute pain by increasing patients' perceived control over their pain experience.

The effectiveness of these psychological interventions may vary based on individual factors like coping style and anxiety levels, suggesting a personalized approach to pain management is beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological strategies in acute pain management. VanDalfsen, PJ., Syrjala, KL.[2011]

Excess gestational weight gain is a significant predictor of long-term obesity risks for both mothers and their children, highlighting pregnancy as a critical time to address weight management.

Current interventions mainly focus on diet and physical activity but show limited effectiveness; thus, there is a growing need to explore psychological strategies to promote healthier weight-related behaviors during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Excess Gestational Weight Gain and Obesity in Pregnancy: the Potential of Targeting Psychological Mechanisms. Blau, LE., Hormes, JM.[2021]

A survey of 141 pregnant women revealed that a significant number did not receive essential advice on physical activity (37.5%), gestational weight gain (53.2%), and nutrition (66.2%), despite over 80% wanting this information.

Women with pre-pregnancy overweight or excessive gestational weight gain were less likely to receive counseling, indicating a need for health professionals to improve communication and support for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Maternal Body Mass and Physical Activity Counseling During Pregnancy. Ruart, S., Sinnapah, S., Hue, O., et al.[2021]

Interventions aimed at limiting gestational weight gain (GWG) were found to be equally effective whether they were based on behavior change theories or not, with 19 studies analyzed in this review.

Key strategies for effective GWG interventions included providing information, motivational interviewing, behavioral self-monitoring, and offering rewards for successful behavior, suggesting that combining these techniques with dietary changes may enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions designed to limit gestational weight gain: a systematic review of theory and meta-analysis of intervention components. Hill, B., Skouteris, H., Fuller-Tyszkiewicz, M.[2022]

The intervention aimed at helping pregnant women manage their weight gain included educational materials and provider counseling, but did not result in significantly different total weight gain compared to the control group (24.5 lbs vs. 25.3 lbs).

However, the intervention was effective in reducing the likelihood of excessive weight gain, with participants being only 34% as likely to exceed the recommended guidelines, indicating its potential for obesity prevention during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing excessive weight gain among publicly insured pregnant women. Rosenbloom, L., Buchert, E., Vasiloff, R., et al.[2021]

A survey of 182 pregnant women revealed that while most received counseling on weight gain and exercise, a significant portion (28% of obese women) did not receive exercise counseling, highlighting a gap in support for maintaining physical activity during pregnancy.

Despite the benefits of exercise, many women reduced their exercise frequency during pregnancy, with 40.6% exercising three or more days a week before pregnancy compared to only 30.7% during pregnancy, indicating a need for better encouragement and resources to promote physical activity among expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Attitudes toward Gestational Weight Gain and Exercise during Pregnancy. Lott, ML., Power, ML., Reed, EG., et al.[2020]

A study involving 34 pregnant women revealed that many were unaware of the health risks associated with excessive weight gain during pregnancy, highlighting a need for better education on this topic.

The research identified four distinct nutritional behavior patterns among pregnant women, suggesting that tailored interventions based on these behaviors could improve outcomes related to weight management and healthy eating during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advising Women to Avoid Excessive Gestational Weight Gain: What do Pregnant Women Think?] Nehring, I., Feurig, S., Roebl-Matthieu, M., et al.[2018]

In a study of 24 pregnant women with overweight or obesity, those who experienced more than one nighttime awakening per week engaged in significantly less physical activity, burning 167.56 fewer calories compared to those with fewer awakenings.

Each additional weekly nighttime awakening was associated with a 0.76-pound increase in gestational weight gain, highlighting the importance of sleep quality in managing weight during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short Nighttime Sleep Duration and High Number of Nighttime Awakenings Explain Increases in Gestational Weight Gain and Decreases in Physical Activity but Not Energy Intake among Pregnant Women with Overweight/Obesity. Pauley, AM., Hohman, EE., Leonard, KS., et al.[2023]

The study involved 31 pregnant women with overweight/obesity and tested an adaptive intervention aimed at regulating gestational weight gain (GWG), showing that the intervention group had a 21% lower GWG compared to the control group, although this difference was not statistically significant.

Participants in the intervention group also demonstrated significantly lower energy intake post-intervention, indicating that the educational and counseling support may help manage dietary habits during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive, behavioral intervention impact on weight gain, physical activity, energy intake, and motivational determinants: results of a feasibility trial in pregnant women with overweight/obesity. Downs, DS., Savage, JS., Rivera, DE., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Results from 10 Years of a CBT Pain Self-Management Outpatient Program for Complex Chronic Conditions. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Attention bias modification training for adolescents with chronic pain: a randomized placebo-controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive and cognitive-behavioral methods for pain control: a selective review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-oriented recovery enhancement reduces pain attentional bias in chronic pain patients. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Psychological strategies in acute pain management. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Preventing Excess Gestational Weight Gain and Obesity in Pregnancy: the Potential of Targeting Psychological Mechanisms. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Association Between Maternal Body Mass and Physical Activity Counseling During Pregnancy. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Interventions designed to limit gestational weight gain: a systematic review of theory and meta-analysis of intervention components. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Preventing excessive weight gain among publicly insured pregnant women. [2021]

10. Egypt pubmed.ncbi.nlm.nih.gov

Patient Attitudes toward Gestational Weight Gain and Exercise during Pregnancy. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

[Advising Women to Avoid Excessive Gestational Weight Gain: What do Pregnant Women Think?] [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Short Nighttime Sleep Duration and High Number of Nighttime Awakenings Explain Increases in Gestational Weight Gain and Decreases in Physical Activity but Not Energy Intake among Pregnant Women with Overweight/Obesity. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Adaptive, behavioral intervention impact on weight gain, physical activity, energy intake, and motivational determinants: results of a feasibility trial in pregnant women with overweight/obesity. [2022]