144 Participants Needed

HMZ 2.0 Intervention for Pregnancy Weight Management

(HMZ Two Trial)

AP
Overseen ByAbigail Pauley, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Penn State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.678910

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.69111213

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.

Eligibility Criteria

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.
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Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: HMZ 2.0 Intervention GroupExperimental Treatment1 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 GroupActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Results from 10 Years of a CBT Pain Self-Management Outpatient Program for Complex Chronic Conditions. [2018]
Attention bias modification training for adolescents with chronic pain: a randomized placebo-controlled trial. [2021]
Cognitive and cognitive-behavioral methods for pain control: a selective review. [2022]
Mindfulness-oriented recovery enhancement reduces pain attentional bias in chronic pain patients. [2013]
Psychological strategies in acute pain management. [2011]
Preventing Excess Gestational Weight Gain and Obesity in Pregnancy: the Potential of Targeting Psychological Mechanisms. [2021]
Association Between Maternal Body Mass and Physical Activity Counseling During Pregnancy. [2021]
Interventions designed to limit gestational weight gain: a systematic review of theory and meta-analysis of intervention components. [2022]
Preventing excessive weight gain among publicly insured pregnant women. [2021]
Patient Attitudes toward Gestational Weight Gain and Exercise during Pregnancy. [2020]
[Advising Women to Avoid Excessive Gestational Weight Gain: What do Pregnant Women Think?] [2018]
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 Statespubmed.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]
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