Weight GainHM2BNCT03063528
Healthy Motivations for Moms-to-be Study
A study testing Healthy Eating and Physical Activity and Stress Reduction and Management in people with Weight Gain and Pregnancy, run by University of South Carolina at 1 site in United States.
Trial summary
This proposal is part of a broader research agenda that posits healthy gestational weight gain (GWG) may be achieved through behavioral intervention and may potentially reduce adverse maternal and infant health outcomes associated with excessive weight gain during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Pregnancy, Stress, Emotional
- What is being tested?
- Healthy Eating and Physical Activity and Stress Reduction and Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
This proposal is part of a broader research agenda that posits healthy gestational weight gain (GWG) may be achieved through behavioral intervention and may potentially reduce adverse maternal and infant health outcomes associated with excessive weight gain during pregnancy. The purpose of this study is to examine the use of a mobile application (mobile app) and mobile website for encouraging and maintaining healthy behaviors such as healthy eating, regular exercise, and stress management and reduction during pregnancy. The study will include collaborative group-based health behavior challenges for pregnant women living in the United States. The study will test the effectiveness of the intervention on improving maternal health behaviors. The proposed research project will examine if an intervention targeting healthy eating and exercise leads to significantly less weight gained during pregnancy versus a comparison group that receives stress reduction and management content.
Read the 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.
- Conditions
- Weight Gain, Pregnancy, Stress, Emotional, Exercise, Nutrition
- Being tested
- Healthy Eating and Physical Activity, Stress Reduction and Management
- Keywords
- Pregnancy, Weight, Gestational weight gain, Stress reduction, Exercise
- Medical subject headings
- Weight Gain, Stress, Psychological, Motor Activity, Body Weight, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating and Physical ActivityBehavioural
Also called HEPA
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.
Stress Reduction and ManagementBehavioural
Also called SRAM
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Eating/Physical Activity (HEPA) | Experimental | 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.
* 12 weeks of group-based health behavior (nutrition/PA focused) challenges and weight tracking; podcasts (10); weekly pregnancy tips
* website and mobile app Receives: Behavioral: Healthy Eating and Physical Activity |
| Stress Reduction/Management (SRAM) | Experimental | 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.
* 12 weeks of group-based health behavior (stress reduction/management) challenges and weight tracking; podcasts (10); weekly pregnancy tips
* website and mobile app Receives: Behavioral: Stress Reduction and Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total gestational weight gain (kg)
Photo-verified scale displays at baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
Measured: baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
Secondary outcomes (3)
Social engagement within group-based challenges
Total engagement score will be computed for app and website usage
Measured: 12 weeks
Podcast listenership
Number of podcasts downloaded by individual participant
Measured: 20-36 weeks
Motivation to change behavior
Surveys administered at baseline (<20 weeks) and 32 weeks
Measured: baseline (<20 weeks) and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start5 Jan 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia A Dahl, MS, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063528
- Sponsor's protocol ID
- Pro00061320
- Acronym
- HM2B
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2017
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Motivations for Moms-to-be Study
- ClinicalTrials.gov ID
- NCT03063528
- Acronym / sponsor ID
- HM2B / Pro00061320
- Conditions
- Weight Gain, Pregnancy, Stress, Emotional, Exercise, Nutrition
- Keywords
- Pregnancy, Weight, Gestational weight gain, Stress reduction, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal is part of a broader research agenda that posits healthy gestational weight gain (GWG) may be achieved through behavioral intervention and may potentially reduce adverse maternal and infant health outcomes associated with excessive weight gain during pregnancy. The purpose of this study is to examine the use of a mobile application (mobile app) and mobile website for encouraging and maintaining healthy behaviors such as healthy eating, regular exercise, and stress management and reduction during pregnancy. The study will include collaborative group-based health behavior challenges for pregnant women living in the United States. The study will test the effectiveness of the intervention on improving maternal health behaviors. The proposed research project will examine if an intervention targeting healthy eating and exercise leads to significantly less weight gained during pregnancy versus a comparison group that receives stress reduction and management content.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Eating/Physical Activity (HEPA) | Experimental | Behavioral: Healthy Eating and Physical ActivityThe 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. * 12 weeks of group-based health behavior (nutrition/PA focused) challenges and weight tracking; podcasts (10); weekly pregnancy tips * website and mobile app |
| Stress Reduction/Management (SRAM) | Experimental | Behavioral: Stress Reduction and ManagementThe 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. * 12 weeks of group-based health behavior (stress reduction/management) challenges and weight tracking; podcasts (10); weekly pregnancy tips * website and mobile app |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant upon enrollment
- Singleton pregnancy
- 20-35 years old
- Current resident of the United States
- Valid email address to receive study updates
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Eating and Physical ActivityAlso: HEPAParticipants 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. | Behavioural | Healthy Eating/Physical Activity (HEPA) |
| Stress Reduction and ManagementAlso: SRAMParticipants 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. | Behavioural | Stress Reduction/Management (SRAM) |
Primary outcome
Total gestational weight gain (kg)
Time frame: baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
Photo-verified scale displays at baseline (<20 weeks), 32 weeks, and delivery (40 weeks)
3 secondary outcomes
Social engagement within group-based challenges
Time frame: 12 weeks
Podcast listenership
Time frame: 20-36 weeks
Motivation to change behavior
Time frame: baseline (<20 weeks) and 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Weight Gain
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
The Safety and Effectiveness of dTMS for Reducing Antipsychotic-induced Weight Gain
Schizophrenia Spectrum, Schizophrenia
RecruitingObservational study
Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
Bariatric Surgery, Pregnency
Active, not recruiting
Time-restricted Eating Among Pregnant Females With Severe Obesity
Obesity, Morbid, Time Restricted Eating
Recruiting
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia A Dahl, MS principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Eating and Physical Activity and Stress Reduction and Management in people with Weight Gain and Pregnancy, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total gestational weight gain (kg) (time frame: baseline (<20 weeks), 32 weeks, and delivery (40 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018; AzTrials last refreshed its copy on 1 Nov 2026.