Gestational Weight GainPhase 3eMOMSNCT01331564
eMOMS of Rochester
A Phase 3 study testing electronic intervention during pregnancy and postpartum and electronic intervention during pregnancy in people with Gestational Weight Gain and Postpartum Weight Retention, run by University of Rochester at 1 site in United States.
Trial summary
The project aims to develop, implement and evaluate electronically-mediated behavioral intervention programs for pregnant and postpartum women in order to prevent excessive weight gain during pregnancy and postpartum weight retention. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain, Postpartum Weight Retention
- What is being tested?
- electronic intervention during pregnancy and postpartum and electronic intervention during pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,641 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2014
- Phase
- Phase 3
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 35 at the time of delivery
- Consented at or before 20 weeks gestation
- Intending to be available for a 24 months intervention
- Plan to deliver in one of the 4 hospitals in Rochester, NY (the study area)
- Plan to carry the pregnancy to term
- Plan to keep the baby
- Read and understand English
Who cannot join
- BMI < 18.5 kg/m2 and > 35.0 kg/m2.
- Multiple gestation. If multiple gestation is diagnosed after enrollment participant will be terminated from the study (reasons for termination will be included in the consent form)
- Medical conditions prior to pregnancy which could influence weight loss or gain: cystic fibrosis, hyperthyroidism, renal insufficiency1, proteinuria1, cerebral palsy, lupus erythematosus; rheumatoid arthritis, Crohns disease (severity and other autoimmune diseases evaluated case by case), ulcerative colitis, maternal congenital heart disease (patients are often underweight); hypertension treated with medication2,
- Psychiatric medication associated with major weight gain or loss (e.g.; Lithium \& Divalproex) Common Criteria
- Household member on study staff
- Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); currently enrolled or planned to enroll in a weight loss or another weight gain prevention study
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- Participants will be excluded during screening if they report regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected- insulin, metformin, byetta, TZDs, other). "Regular use" is defined as "taking this medication most days of the week for the previous month"
- Current treatment for eating disorder
- Positive screening for bulimia
- Weight loss of more than 15 pounds in the three months prior to pregnancy
- Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 month. Revascularization is defined as bypass surgery or stints
- Mental or psychiatric condition that precludes giving informed consent and completing questionnaires
- Current treatment for malignancy (other than non-melanoma skin cancer and CIN cervix) or on remission for less than 5 years
- Blood pressure criterion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women
The project aims to develop, implement and evaluate electronically-mediated behavioral intervention programs for pregnant and postpartum women in order to prevent excessive weight gain during pregnancy and postpartum weight retention.
Read the detailed description
This study seeks to expand the understanding of how to slow the accumulation of weight in childbearing women. The intervention goals are to decrease the prevalence of excessive pregnancy weight gain and mean weight retention in the first 18 months postpartum in socio-economically and racially/ethnically diverse sample of 1,641 pregnant women. Women will be randomly assigned to one of three groups: Intervention Group 1 will receive the intervention program only during pregnancy (e-intervention 1). Intervention Group 2 will receive e-intervention 1 plus intervention for 18 months postpartum (e-intervention 2). Control women will receive non-weight related content during both time periods at the project website. The primary hypotheses for the randomized controlled trial are: H1: The proportion of women in Intervention Groups 1 and 2 who gain more weight in pregnancy than is recommended by the IOM will be 33% less than the proportion of the women in the Control Group who gain excessively and H2: The Control Group will have a higher mean weight retention at 12 months postpartum than Intervention Groups 1 and 2.
- Being tested
- electronic intervention during pregnancy and postpartum, electronic intervention during pregnancy, Control
- Keywords
- Pregnancy, Postpartum, Weight gain, Weight retention, Behavior, Electronic Media, Randomized Clinical Trial
- Medical subject headings
- Gestational Weight Gain, Weight Gain, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic intervention during pregnancy and postpartumBehavioural
Also called Behavior modification intervention for pregnancy, Behavior modification intervention for postpartum, Prevention of excessive gestational weight gain, Prevention of postpartum weight retention
Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy and to follow a healthy lifestyle postpartum to minimize postpartum weight retention
electronic intervention during pregnancyBehavioural
Also called Behavior modification intervention for pregnancy, Prevention of excessive gestational weight gain, Electronically-mediated behavioral interventions
Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.
ControlBehavioural
Also called Control group
Control women will receive non-weight related content during both time periods at the project website.
| Study group | Role | What they receive |
|---|---|---|
| electronic intervention group 2 | Experimental | (e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum Receives: Behavioral: electronic intervention during pregnancy and postpartum |
| electronic intervention group 1 | Experimental | (e-intervention 1) receives a behavioral intervention through a website during pregnancy. During the postpartum period this arm receives the same non-weight-related information as the control arm Receives: Behavioral: electronic intervention during pregnancy |
| Control | Placebo comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms
Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight).
Measured: 40 weeks
Postpartum weight retention in kg at 12 months postpartum
The difference between the weight at 12 months postpartum and the pre-pregnancy weight (or early pregnancy weight. Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum.
Measured: 1.5 years
Secondary outcomes (3)
Caloric Intake in Kilocalories
Caloric intake will be calculated based on the average food intake assessed by 2 24-hour dietary recall.
Measured: 2 years
Physical activity as an average weekly energy expenditure (METS)
Physical activity during pregnancy is measured using the Pregnancy Physical Activity Questionnaire and during postpartum using the Global Physical Activity Questionnaire.
Measured: 2 years
Postpartum weight retention at 18 months
The difference between the weight at 18 months postpartum and the prepregnancy weight (or early pregnancy weight). Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gestational Weight GainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,641 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Principal investigator, Diana Fernandez, University of Rochester
- Investigators
- Isabel D Fernandez, MD, MPH, PhD, Principal investigator, University of RochesterChristine M Olson, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331564
- Sponsor's protocol ID
- HL096760
- Acronym
- eMOMS
- Status last verified
- Nov 2015
- First submitted
- 31 Mar 2011
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yu Y, Ma Q, Fernandez ID, Groth SW. Mental Health, Behavior Change Skills, and Eating Behaviors in Postpartum Women. West J Nurs Res. 2022 Oct;44(10):932-945. doi: 10.1177/01939459211021625. Epub 2021 Jun 4.
PubMed 34088249Olson CM, Groth SW, Graham ML, Reschke JE, Strawderman MS, Fernandez ID. The effectiveness of an online intervention in preventing excessive gestational weight gain: the e-moms roc randomized controlled trial. BMC Pregnancy Childbirth. 2018 May 9;18(1):148. doi: 10.1186/s12884-018-1767-4.
PubMed 29743026Olson CM, Strawderman MS, Graham ML. Association between consistent weight gain tracking and gestational weight gain: Secondary analysis of a randomized trial. Obesity (Silver Spring). 2017 Jul;25(7):1217-1227. doi: 10.1002/oby.21873. Epub 2017 Jun 2.
PubMed 28573669Graham ML, Strawderman MS, Demment M, Olson CM. Does Usage of an eHealth Intervention Reduce the Risk of Excessive Gestational Weight Gain? Secondary Analysis From a Randomized Controlled Trial. J Med Internet Res. 2017 Jan 9;19(1):e6. doi: 10.2196/jmir.6644.
PubMed 28069560Fernandez ID, Groth SW, Reschke JE, Graham ML, Strawderman M, Olson CM. eMoms: Electronically-mediated weight interventions for pregnant and postpartum women. Study design and baseline characteristics. Contemp Clin Trials. 2015 Jul;43:63-74. doi: 10.1016/j.cct.2015.04.013. Epub 2015 May 6.
PubMed 25957183Demment MM, Graham ML, Olson CM. How an online intervention to prevent excessive gestational weight gain is used and by whom: a randomized controlled process evaluation. J Med Internet Res. 2014 Aug 20;16(8):e194. doi: 10.2196/jmir.3483.
PubMed 25143156
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women
- ClinicalTrials.gov ID
- NCT01331564
- Acronym / sponsor ID
- eMOMS / HL096760
- Keywords
- Pregnancy, Postpartum, Weight gain, Weight retention, Behavior, Electronic Media, Randomized Clinical Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,641 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Apr 2011 (estimated)
- 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.
The project aims to develop, implement and evaluate electronically-mediated behavioral intervention programs for pregnant and postpartum women in order to prevent excessive weight gain during pregnancy and postpartum weight retention.
Detailed description
This study seeks to expand the understanding of how to slow the accumulation of weight in childbearing women. The intervention goals are to decrease the prevalence of excessive pregnancy weight gain and mean weight retention in the first 18 months postpartum in socio-economically and racially/ethnically diverse sample of 1,641 pregnant women. Women will be randomly assigned to one of three groups: Intervention Group 1 will receive the intervention program only during pregnancy (e-intervention 1). Intervention Group 2 will receive e-intervention 1 plus intervention for 18 months postpartum (e-intervention 2). Control women will receive non-weight related content during both time periods at the project website. The primary hypotheses for the randomized controlled trial are: H1: The proportion of women in Intervention Groups 1 and 2 who gain more weight in pregnancy than is recommended by the IOM will be 33% less than the proportion of the women in the Control Group who gain excessively and H2: The Control Group will have a higher mean weight retention at 12 months postpartum than Intervention Groups 1 and 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| electronic intervention group 2 | Experimental | Behavioral: electronic intervention during pregnancy and postpartum(e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum |
| electronic intervention group 1 | Experimental | Behavioral: electronic intervention during pregnancy(e-intervention 1) receives a behavioral intervention through a website during pregnancy. During the postpartum period this arm receives the same non-weight-related information as the control arm |
| Control | Placebo comparator | Behavioral: Control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 - 35 at the time of delivery
- Consented at or before 20 weeks gestation
- Intending to be available for a 24 months intervention
- Plan to deliver in one of the 4 hospitals in Rochester, NY (the study area)
- Plan to carry the pregnancy to term
Key exclusion criteria (14 listed)
- BMI < 18.5 kg/m2 and > 35.0 kg/m2.
- Multiple gestation. If multiple gestation is diagnosed after enrollment participant will be terminated from the study (reasons for termination will be included in the consent form)
- Medical conditions prior to pregnancy which could influence weight loss or gain: cystic fibrosis, hyperthyroidism, renal insufficiency1, proteinuria1, cerebral palsy, lupus erythematosus; rheumatoid arthritis, Crohns disease (severity and other autoimmune diseases evaluated case by case), ulcerative colitis, maternal congenital heart disease (patients are often underweight); hypertension treated with medication2,
- Psychiatric medication associated with major weight gain or loss (e.g.; Lithium \& Divalproex) Common Criteria
- Household member on study staff
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 |
|---|---|---|
| electronic intervention during pregnancy and postpartumAlso: Behavior modification intervention for pregnancy, Behavior modification intervention for postpartum, Prevention of excessive gestational weight gain, Prevention of postpartum weight retentionElectronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy and to follow a healthy lifestyle postpartum to minimize postpartum weight retention | Behavioural | electronic intervention group 2 |
| electronic intervention during pregnancyAlso: Behavior modification intervention for pregnancy, Prevention of excessive gestational weight gain, Electronically-mediated behavioral interventionsElectronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy. | Behavioural | electronic intervention group 1 |
| ControlAlso: Control groupControl women will receive non-weight related content during both time periods at the project website. | Behavioural | Control |
Primary outcome
Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms
Time frame: 40 weeks
Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight).
Postpartum weight retention in kg at 12 months postpartum
Time frame: 1.5 years
The difference between the weight at 12 months postpartum and the pre-pregnancy weight (or early pregnancy weight. Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum.
3 secondary outcomes
Caloric Intake in Kilocalories
Time frame: 2 years
Physical activity as an average weekly energy expenditure (METS)
Time frame: 2 years
Postpartum weight retention at 18 months
Time frame: 2 years
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 2 Dec 2015.
- Derived from this study: PubMed 34088249Yu Y, Ma Q, Fernandez ID, Groth SW. Mental Health, Behavior Change Skills, and Eating Behaviors in Postpartum Women. West J Nurs Res. 2022 Oct;44(10):932-945. doi: 10.1177/01939459211021625. Epub 2021 Jun 4.
- Derived from this study: PubMed 29743026Olson CM, Groth SW, Graham ML, Reschke JE, Strawderman MS, Fernandez ID. The effectiveness of an online intervention in preventing excessive gestational weight gain: the e-moms roc randomized controlled trial. BMC Pregnancy Childbirth. 2018 May 9;18(1):148. doi: 10.1186/s12884-018-1767-4.
- Derived from this study: PubMed 28573669Olson CM, Strawderman MS, Graham ML. Association between consistent weight gain tracking and gestational weight gain: Secondary analysis of a randomized trial. Obesity (Silver Spring). 2017 Jul;25(7):1217-1227. doi: 10.1002/oby.21873. Epub 2017 Jun 2.
- Derived from this study: PubMed 28069560Graham ML, Strawderman MS, Demment M, Olson CM. Does Usage of an eHealth Intervention Reduce the Risk of Excessive Gestational Weight Gain? Secondary Analysis From a Randomized Controlled Trial. J Med Internet Res. 2017 Jan 9;19(1):e6. doi: 10.2196/jmir.6644.
- Derived from this study: PubMed 25957183Fernandez ID, Groth SW, Reschke JE, Graham ML, Strawderman M, Olson CM. eMoms: Electronically-mediated weight interventions for pregnant and postpartum women. Study design and baseline characteristics. Contemp Clin Trials. 2015 Jul;43:63-74. doi: 10.1016/j.cct.2015.04.013. Epub 2015 May 6.
- Derived from this study: PubMed 25143156Demment MM, Graham ML, Olson CM. How an online intervention to prevent excessive gestational weight gain is used and by whom: a randomized controlled process evaluation. J Med Internet Res. 2014 Aug 20;16(8):e194. doi: 10.2196/jmir.3483.
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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.
Isabel D Fernandez, MD, MPH, PhD principal investigator
University of Rochester
Christine M Olson, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing electronic intervention during pregnancy and postpartum and electronic intervention during pregnancy in people with Gestational Weight Gain and Postpartum Weight Retention, run by University of Rochester 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 7 inclusion and 14 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 2 Dec 2015. 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. Some participants in this study may receive a placebo. 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?
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?
Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms (time frame: 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331564, which also lists 6 linked publications.
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 2 Dec 2015.