MomZing Exercise Videos OnlinePhase 3MamaMoveNCT01738984
A Home Exercise Program for Women With Infants & Young Children
A Phase 3 study testing MomZing Web Program and Standard Exercise DVD in people with MomZing Exercise Videos Online and Standard Exercise DVD, run by University of Hawaii at 2 sites in United States.
Trial summary
This Phase II Small Business Technology Transfer(STTR) project will develop and test the effectiveness of an interactive web program optimized for use on a Internet connected television(TV), titled Moms Exercising or (MomZing) that is designed specifically for women with infants 2-8 months old. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- MomZing Exercise Videos Online, Standard Exercise DVD
- What is being tested?
- MomZing Web Program and Standard Exercise DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman aged 18-45 who has an infant 2-8 months old (who weighs 11-22 lbs)
- live in one of the 50 states in US
- have broadband, high speed wireless internet access at home
- have high definition, flat screen TV at home
- have DVD player at home
- sedentary (<30 minutes of exercise per week)
Show all 10Show fewer
- BMI between 17-40
- healthy woman
- healthy infant
- likes to learn about new technology
Who cannot join
- woman has health problems: pregnant or planning to become pregnant in next 3 months, dizziness/loss of consciousness, bone/joint problems that would be made worse by exercise, cancer, coronary heart disease (chest pain),insulin dependent diabetic, exercise -induced asthma or other atherosclerotic cardiovascular diseases, on medication for heart condition/high blood pressure, doctor has limited the amount of physical exertion/exercising.
- Baby has health problems -a chronic illness/disorder that would prevent mother from holding or lifting him/her in her arms while exercising
- Woman cannot read/write English
- woman unable or unwilling to connect a device to her television at home to link it to her home's wireless network
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cheryl Albright, PhD, MPH
Honolulu, Hawaii, 96813
University of Hawaii at Manoa
Honolulu, Hawaii, 96813
About this study
This Phase II Small Business Technology Transfer(STTR) project will develop and test the effectiveness of an interactive web program optimized for use on a Internet connected television(TV), titled Moms Exercising or (MomZing) that is designed specifically for women with infants 2-8 months old. Moms will select from a menu of 98, 10-minute exercise videos demonstrating yoga, aerobics, and strengthening exercises. They select and sequence together exercise videos personalized to their fitness level, form of exercise, and the choice to actively exercise with her baby or alone. The primary health goal of the MomZing Program is to increase home-based Moderate to Vigorous Physical Activity (MPVA) minutes per week in new mothers and to maintain their exercise increases over time as their baby grows.
The investigators hypothesize that women that use the MomZing Program will have greater increases in physical activity and fewer will return to cigarette smoking or alcohol use, compared to women who use a standard "mommy and me" exercise DVD.
Read the detailed description
Becoming a mother is a significant transition in a woman's life, and while this is a positive experience for many, there can be significant decreases in healthful behaviors such as physical activity and increases in unhealthy behaviors including sleep deprivation, stress, and depressive symptoms. Increasing postpartum physical activity can have multiple health benefits including risk reduction for chronic diseases like diabetes and cardiovascular disease, and improvement in psychological health including decreased stress and depressive symptoms. Improvements in mental health outcomes can prevent substance use since psychological stress is a risk factor for substance use and abuse. The postpartum period also represents a critical period to prevent a return to substance use, including tobacco and alcohol.
This Small Business Technology Transfer(STTR)- Phase II project will develop and test an interactive web-enabled television program, titled Mothers Exercising or ("MomZing). Features include the ability to select one to five 10-minute videos demonstrating yoga, aerobics, and strengthening exercises for mothers with infants 2 to 8 months of age. Women will select and sequence together videos personalized to their fitness level, preference for exercise type, and the choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding. MomZing is designed for viewing on a television taking advantage of new technologies that allow viewers to watch streaming video (including movies) from the internet on a television. The television can also be connected to the internet via a web-enabled console such as an internet-connecting device.
The primary goal of the MomZing web-enabled Program is to increase home-based moderate-to-vigorous physical activity (MVPA) minutes per week in new mothers. Phase II activities will include: 1) programming the MomZing multimedia web enabled Program, a recruitment website, and online survey; 2) producing 98,10-minute video segments showing women exercising with or without an infant; 3) conducting iterative usability testing of the features and content of the Program; and, 4) conducting a randomized trial of the efficacy of the Program with 572 new mothers recruited from across the U.S. New mothers will be randomly assigned to receive either the MomZing web-enabled TV Program or a standard exercise DVD designed for new mothers. The primary outcome will be minutes per week of leisure-time moderate to vigorous physical activity measured at baseline, 4 and 12 weeks. Secondary outcomes include changes in fatigue, sleep, depressive symptoms, tobacco and alcohol use at 12 weeks. Process evaluation will also determine extent to which the technology is utilized (frequency of use and time per access) over 12 weeks in both conditions. We will investigate whether key demographic (i.e., weight of infant, number of children) physiological (i.e., body mass index), and lifestyle factors (sleep quality, fatigue) act as mediators or moderators of any change in physical activity.
The MomZing Program will allow Moms to tailor a range of exercise options to meet their needs and those of their infant. As their infant grows and progresses through different cognitive and developmental stages the Program can grow with them, allowing the Mom to change her preferences unlike any exercise multimedia(DVD or website) currently available on the market.
- Being tested
- MomZing Web Program, Standard Exercise DVD
- Keywords
- exercise, video, DVD, mother, infant
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MomZing Web ProgramBehavioural
Online web platform that is accessed via a television connected to internet
Standard Exercise DVDBehavioural
Standard exercise DVD that demonstrates exercises a women does with an infant.
| Study group | Role | What they receive |
|---|---|---|
| MomZing Web Program | Experimental | Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding. Receives: Behavioral: MomZing Web Program |
| Standard exercise DVD | Experimental | Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant. Receives: Behavioral: Standard Exercise DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes Per Week of Moderate-to-Vigorous Physical Activity (MPVA Min/wk) Assessed at 12 Weeks
physical activity will be obtained via online surveys at the 12 week assessment point
Measured: 12 weeks
Secondary outcomes (1)
Number Who Returned to Smoking From Baseline and 12 Weeks
change in smoking status between baseline and 12 week assessment will be collected via survey at baseline and at the 12 week survey
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MomZing Exercise Videos OnlineStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Klein Buendel, Inc.
- Responsible party
- Sponsor
- Investigators
- Cheryl L Albright, PhD, MPH, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738984
- Sponsor's protocol ID
- 9R42DA031402
- Acronym
- MamaMove
- Status last verified
- Mar 2016
- First submitted
- 28 Nov 2012
- Last updated
- 12 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home Exercise Program for Women With Infants & Young Children
- ClinicalTrials.gov ID
- NCT01738984
- Acronym / sponsor ID
- MamaMove / 9R42DA031402
- Keywords
- exercise, video, DVD, mother, infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Klein Buendel, Inc.
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 12 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II Small Business Technology Transfer(STTR) project will develop and test the effectiveness of an interactive web program optimized for use on a Internet connected television(TV), titled Moms Exercising or (MomZing) that is designed specifically for women with infants 2-8 months old. Moms will select from a menu of 98, 10-minute exercise videos demonstrating yoga, aerobics, and strengthening exercises. They select and sequence together exercise videos personalized to their fitness level, form of exercise, and the choice to actively exercise with her baby or alone. The primary health goal of the MomZing Program is to increase home-based Moderate to Vigorous Physical Activity (MPVA) minutes per week in new mothers and to maintain their exercise increases over time as their baby grows.
The investigators hypothesize that women that use the MomZing Program will have greater increases in physical activity and fewer will return to cigarette smoking or alcohol use, compared to women who use a standard "mommy and me" exercise DVD.
Detailed description
Becoming a mother is a significant transition in a woman's life, and while this is a positive experience for many, there can be significant decreases in healthful behaviors such as physical activity and increases in unhealthy behaviors including sleep deprivation, stress, and depressive symptoms. Increasing postpartum physical activity can have multiple health benefits including risk reduction for chronic diseases like diabetes and cardiovascular disease, and improvement in psychological health including decreased stress and depressive symptoms. Improvements in mental health outcomes can prevent substance use since psychological stress is a risk factor for substance use and abuse. The postpartum period also represents a critical period to prevent a return to substance use, including tobacco and alcohol.
This Small Business Technology Transfer(STTR)- Phase II project will develop and test an interactive web-enabled television program, titled Mothers Exercising or ("MomZing). Features include the ability to select one to five 10-minute videos demonstrating yoga, aerobics, and strengthening exercises for mothers with infants 2 to 8 months of age. Women will select and sequence together videos personalized to their fitness level, preference for exercise type, and the choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding. MomZing is designed for viewing on a television taking advantage of new technologies that allow viewers to watch streaming video (including movies) from the internet on a television. The television can also be connected to the internet via a web-enabled console such as an internet-connecting device.
The primary goal of the MomZing web-enabled Program is to increase home-based moderate-to-vigorous physical activity (MVPA) minutes per week in new mothers. Phase II activities will include: 1) programming the MomZing multimedia web enabled Program, a recruitment website, and online survey; 2) producing 98,10-minute video segments showing women exercising with or without an infant; 3) conducting iterative usability testing of the features and content of the Program; and, 4) conducting a randomized trial of the efficacy of the Program with 572 new mothers recruited from across the U.S. New mothers will be randomly assigned to receive either the MomZing web-enabled TV Program or a standard exercise DVD designed for new mothers. The primary outcome will be minutes per week of leisure-time moderate to vigorous physical activity measured at baseline, 4 and 12 weeks. Secondary outcomes include changes in fatigue, sleep, depressive symptoms, tobacco and alcohol use at 12 weeks. Process evaluation will also determine extent to which the technology is utilized (frequency of use and time per access) over 12 weeks in both conditions. We will investigate whether key demographic (i.e., weight of infant, number of children) physiological (i.e., body mass index), and lifestyle factors (sleep quality, fatigue) act as mediators or moderators of any change in physical activity.
The MomZing Program will allow Moms to tailor a range of exercise options to meet their needs and those of their infant. As their infant grows and progresses through different cognitive and developmental stages the Program can grow with them, allowing the Mom to change her preferences unlike any exercise multimedia(DVD or website) currently available on the market.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MomZing Web Program | Experimental | Behavioral: MomZing Web ProgramFeatures include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding. |
| Standard exercise DVD | Experimental | Behavioral: Standard Exercise DVDExercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- woman aged 18-45 who has an infant 2-8 months old (who weighs 11-22 lbs)
- live in one of the 50 states in US
- have broadband, high speed wireless internet access at home
- have high definition, flat screen TV at home
- have DVD player at home
Key exclusion criteria (4 listed)
- woman has health problems: pregnant or planning to become pregnant in next 3 months, dizziness/loss of consciousness, bone/joint problems that would be made worse by exercise, cancer, coronary heart disease (chest pain),insulin dependent diabetic, exercise -induced asthma or other atherosclerotic cardiovascular diseases, on medication for heart condition/high blood pressure, doctor has limited the amount of physical exertion/exercising.
- Baby has health problems -a chronic illness/disorder that would prevent mother from holding or lifting him/her in her arms while exercising
- Woman cannot read/write English
- woman unable or unwilling to connect a device to her television at home to link it to her home's wireless network
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 |
|---|---|---|
| MomZing Web ProgramOnline web platform that is accessed via a television connected to internet | Behavioural | MomZing Web Program |
| Standard Exercise DVDStandard exercise DVD that demonstrates exercises a women does with an infant. | Behavioural | Standard exercise DVD |
Primary outcome
Minutes Per Week of Moderate-to-Vigorous Physical Activity (MPVA Min/wk) Assessed at 12 Weeks
Time frame: 12 weeks
physical activity will be obtained via online surveys at the 12 week assessment point
1 secondary outcome
Number Who Returned to Smoking From Baseline and 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- recruitment websiteLink provided by the sponsor.
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.
Cheryl L Albright, PhD, MPH principal investigator
University of Hawaii
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MomZing Web Program and Standard Exercise DVD in people with MomZing Exercise Videos Online and Standard Exercise DVD, run by University of Hawaii at 2 sites 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 10 inclusion and 4 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 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Minutes Per Week of Moderate-to-Vigorous Physical Activity (MPVA Min/wk) Assessed at 12 Weeks (time frame: 12 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 12 Apr 2016.