Postpartum Weight RetentionE-MomsNCT01751230
A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
A study testing WIC E-Moms in people with Postpartum Weight Retention, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to help women lose the weight they gained during their pregnancy using a SmartPhone app the investigators have developed called E-Moms. The investigators hypothesize that the moms given the app to use during the study will lose more weight than the moms who do not use the app. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Weight Retention
- What is being tested?
- WIC E-Moms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2014
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are a female who has delivered a baby within the last 2 months
- Are 18 years of age or older
- Have a body mass index ≥25 kg/m2 or <40 kg/m2
- Are accepted for post-pregnancy WIC services
- Are English-speaking
Who cannot join
- Are participating in the Nurse Family Partnership program
- Had multiples in your most recent pregnancy
- Are unwilling to be assigned at random to either of the 2 study groups
- Are planning to move out of the study area within the next 6 months
- Have a history of psychiatric conditions or chronic disease than can impact body weight, appetite, or energy intake such as HIV/AIDS, cancer, bipolar disorder or schizophrenia
- Currently use antipsychotic medications or have used such medications in the previous 12 months
Show all 12Show fewer
- Have been diagnosis with type I diabetes
- Report having a heart attack, stroke, or being hospitalized or treated for chest pain
- Currently taking medications or supplements to aid in weight loss
- Have had weight loss surgery in the past year or plan to have it prior to study completion.
- Currently participating in another interventional study that influences weight control
- Currently abusing drugs or alcohol (up to 14 drinks per week allowed)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: E-Moms: A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
The purpose of this study is to help women lose the weight they gained during their pregnancy using a SmartPhone app the investigators have developed called E-Moms. The investigators hypothesize that the moms given the app to use during the study will lose more weight than the moms who do not use the app.
Read the detailed description
The E-Moms Study will last about 4 months. The weight management program is 4 months long and will end about 6 months after the participant's baby is born. All participants will receive Women, Infants and Children (WIC) services.
For the weight management program, participants will be put into one of these groups:
- WIC Moms: receive advice and services for nutrition and weight management after pregnancy from their WIC clinic.
- WIC E-Moms: receive a personalized diet and exercise plan to help them lose the weight they gained during their pregnancy. All information will be given to them using a SmartPhone, such as an iPhone. They will also get advice and services from your WIC clinic.
- Conditions
- Postpartum Weight Retention
- Being tested
- WIC E-Moms
- Keywords
- pregnancy, weight loss
- Medical subject headings
- Gestational Weight Gain, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIC E-MomsBehavioural
Also called E-Moms
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
| Study group | Role | What they receive |
|---|---|---|
| WIC E-Moms | Experimental | If picked for this group, you will receive a personalized diet and exercise plan to help you lose the weight you gained during your pregnancy. All information will be given to you using a SmartPhone, such as an iPhone. You can use your own phone or one can be loaned to you for the study. You will also be loaned a scale so you can weigh yourself at home. You will also get advice and services from your WIC clinic. Receives: Behavioral: WIC E-Moms |
| WIC Moms | No intervention | You will get advice and services for nutrition and weight management after pregnancy from your WIC clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Change
The primary outcome measure is weight change after the 16 week intervention.
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionOct 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 Postpartum Weight RetentionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne Redman, M.S., Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751230
- Sponsor's protocol ID
- PBRC 12030
- Acronym
- E-Moms
- Status last verified
- Aug 2021
- First submitted
- 13 Dec 2012
- Last updated
- 24 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study data available upon request and following appropriate data transfer agreements in place.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Moms: A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
- ClinicalTrials.gov ID
- NCT01751230
- Acronym / sponsor ID
- E-Moms / PBRC 12030
- Conditions
- Postpartum Weight Retention
- Keywords
- pregnancy, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, United States Department of Agriculture (USDA)
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to help women lose the weight they gained during their pregnancy using a SmartPhone app the investigators have developed called E-Moms. The investigators hypothesize that the moms given the app to use during the study will lose more weight than the moms who do not use the app.
Detailed description
The E-Moms Study will last about 4 months. The weight management program is 4 months long and will end about 6 months after the participant's baby is born. All participants will receive Women, Infants and Children (WIC) services.
For the weight management program, participants will be put into one of these groups:
- WIC Moms: receive advice and services for nutrition and weight management after pregnancy from their WIC clinic.
- WIC E-Moms: receive a personalized diet and exercise plan to help them lose the weight they gained during their pregnancy. All information will be given to them using a SmartPhone, such as an iPhone. They will also get advice and services from your WIC clinic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WIC E-Moms | Experimental | Behavioral: WIC E-MomsIf picked for this group, you will receive a personalized diet and exercise plan to help you lose the weight you gained during your pregnancy. All information will be given to you using a SmartPhone, such as an iPhone. You can use your own phone or one can be loaned to you for the study. You will also be loaned a scale so you can weigh yourself at home. You will also get advice and services from your WIC clinic. |
| WIC Moms | No intervention | –You will get advice and services for nutrition and weight management after pregnancy from your WIC clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are a female who has delivered a baby within the last 2 months
- Are 18 years of age or older
- Have a body mass index ≥25 kg/m2 or <40 kg/m2
- Are accepted for post-pregnancy WIC services
- Are English-speaking
Key exclusion criteria (12 listed)
- Are participating in the Nurse Family Partnership program
- Had multiples in your most recent pregnancy
- Are unwilling to be assigned at random to either of the 2 study groups
- Are planning to move out of the study area within the next 6 months
- Have a history of psychiatric conditions or chronic disease than can impact body weight, appetite, or energy intake such as HIV/AIDS, cancer, bipolar disorder or schizophrenia
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 |
|---|---|---|
| WIC E-MomsAlso: E-MomsParticipants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week. | Behavioural | WIC E-Moms |
Primary outcome
Body Weight Change
Time frame: Baseline and 16 weeks
The primary outcome measure is weight change after the 16 week intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Study data available upon request and following appropriate data transfer agreements in place.
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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.
Leanne Redman, M.S., Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIC E-Moms in people with Postpartum Weight Retention, run by Pennington Biomedical Research Center 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 5 inclusion and 12 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 24 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2019). 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?
Body Weight Change (time frame: Baseline and 16 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 24 Aug 2021.