- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03063528
Healthy Motivations for Moms-to-be Study (HM2B)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to test the effects of a mobile app and study website for a gestational weight gain intervention targeted to pregnant women living anywhere in the United States (n=130). Participants will be assigned to groups of 8-12 and assigned to two conditions: intervention or comparison. The intervention groups will receive a weight-related intervention (focused on fruit and vegetable intake, self-regulation of foods, and physical activity (PA)), while the comparison groups will receive a non-diet/PA health behavior program (focused on sleep, stress reduction, mental health, and stress management). Participants will be instructed on how to use the a commercially available free mobile app and study website. Each week for 12 consecutive weeks, participants will receive a health related behavioral goal through the mobile app. Participants can track their goal achievements through the app and connect with other pregnant women in the study. The study website will have participants log daily body weight or stress level, based on their respective group assignments. The study website will also offer 10 podcasts and weekly pregnancy tips related to the study content of both groups. Participants will also be asked to complete three online surveys and provide a report of body weight at three time points throughout pregnancy. Participants will receive an incentive gift for their participation.
The proposed research project is significant for several reasons: (1) rates of overweight and obesity among pregnant and postpartum women are increasing, (2) overweight and obesity is associated with unfavorable maternal and child health outcomes and (3) past research has demonstrated the importance of providing social support during pregnancy to reduce antenatal and postpartum depression.
The proposed research project is innovative for several reasons: (1) current modes of delivering interventions are costly and may be limited in reach and scope while mobile technology provides a solution to these burdens, (2) this intervention is the first of its kind to utilize a commercially-available mobile app to address GWG among pregnant women living in the US, (3) using mobile technology for all aspects of the study will allow greater reach to rural populations who have limited ability to regularly receive health information, and (4) this intervention will employ social support strategies by grouping pregnant women into small groups assigned with a weekly weight-related health goal.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant upon enrollment
- Singleton pregnancy
- 20-35 years old
- Current resident of the United States
- Valid email address to receive study updates
- Owner of an Android or iPhone and willing to download a commercially-available, free mobile app
Exclusion Criteria:
- Does not own or cannot access a scale to weigh themselves regularly
- Has uncontrolled/untreated thyroid disease
- Currently takes insulin for diabetes
- Has high blood pressure that is not controlled
- Has had persistent bleeding in the first trimester
- Has a history of 3 or more miscarriages
- Has a history of incompetent (weakened) cervix
- Currently has or has ever had an eating disorder or malnutrition
- Has physical disabilities that prevent her from exercising
- Was told by her doctor that she should NOT exercise during pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy Eating/Physical Activity (HEPA)
The goals of the HEPA condition are to encourage healthy eating and physical activity behaviors for gaining a healthy amount of weight during pregnancy and to provide motivation and social support to help overcome challenges to eating healthier and becoming more physically active while pregnant.
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Participants will be assigned to a group of 8-10 other pregnant women to work towards the same healthy eating or physical activity behavior challenge each week for a total of 12 weeks.
The challenges will not require travel or financial support, but will focus on modifying or encouraging daily lifestyle activities, such as "drink 8 full glasses of water 3 times this week."
Participants will track their healthy eating and physical activity behaviors in a mobile app.
The HEPA condition will have access to podcasts and informational tips for having a healthy pregnancy through the study website.
The HEPA condition will be able to log their weight on a daily basis and track their overall weight gain on a chart through the study website.
Other Names:
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EXPERIMENTAL: Stress Reduction/Management (SRAM)
The goals of the SRAM condition are to encourage stress reduction and management techniques as well as to provide motivation and social support to reduce stress levels during pregnancy.
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Participants will be put into a group of 8-10 other pregnant women to work towards the same stress reduction and management goal each week for a total of 12 weeks.
The challenges will not require travel or financial support, but will focus on modifying or encouraging daily lifestyle activities, such as "take a 15 minute technology break each day this week."
Participants will track their stress reduction and management behaviors in a mobile app.
In addition, the SRAM condition will have access to meditation podcasts and informational tips for having a healthy pregnancy through the study website.
Lastly, the SRAM condition will be able to rate their stress level on a daily basis and track their stress on a graph.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total gestational weight gain (kg)
Time Frame: baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
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Photo-verified scale displays at baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
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baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social engagement within group-based challenges
Time Frame: 12 weeks
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Total engagement score will be computed for app and website usage
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12 weeks
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Podcast listenership
Time Frame: 20-36 weeks
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Number of podcasts downloaded by individual participant
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20-36 weeks
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Motivation to change behavior
Time Frame: baseline (<20 weeks) and 32 weeks
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Surveys administered at baseline (<20 weeks) and 32 weeks
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baseline (<20 weeks) and 32 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alicia A Dahl, MS, University of South Carolina
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00061320
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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