Weight GainPhase 3NCT01117961
Promoting Healthy Weight Gain During Pregnancy
A Phase 3 study testing Lifestyle in people with Weight Gain, run by The Miriam Hospital.
Trial summary
Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to May 2012
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking, adults,
- < 16 weeks gestation
Who cannot join
- medical comorbidities
About this study
Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.
It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.
- Conditions
- Weight Gain
- Being tested
- Lifestyle
- Keywords
- Excessive gestational weight gain
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleBehavioural
Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| Intervention | Experimental | Lifestyle intervention delivered during pregnancy Receives: Behavioral: Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women above the Institute of Medicine Guidelines for gestational weight gain
Objective measures of weight collected by trained staff on calibrated scales at study entry and after delivery to classify women as above or below the Institute of Medicine Guidelines for gestational weight gain
Measured: 40 weeks
Secondary outcomes (1)
Behavioral measures
The Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startMar 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- California Polytechnic State University-San Luis Obispo, Women and Infants Hospital of Rhode Island, University of California, Berkeley
- Responsible party
- Principal investigator, Rena R. Wing, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117961
- Sponsor's protocol ID
- CMTT# 2035-06
- Status last verified
- Apr 2013
- First submitted
- 15 Apr 2010
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mercado A, Marquez B, Abrams B, Phipps MG, Wing RR, Phelan S. Where Do Women Get Advice About Weight, Eating, and Physical Activity During Pregnancy? J Womens Health (Larchmt). 2017 Sep;26(9):951-956. doi: 10.1089/jwh.2016.6078. Epub 2017 May 19.
PubMed 28525293Phelan S, Phipps MG, Abrams B, Darroch F, Grantham K, Schaffner A, Wing RR. Does behavioral intervention in pregnancy reduce postpartum weight retention? Twelve-month outcomes of the Fit for Delivery randomized trial. Am J Clin Nutr. 2014 Feb;99(2):302-11. doi: 10.3945/ajcn.113.070151. Epub 2013 Nov 27.
PubMed 24284438Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.
PubMed 21310836
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Weight Gain During Pregnancy
- ClinicalTrials.gov ID
- NCT01117961
- Acronym / sponsor ID
- CMTT# 2035-06
- Conditions
- Weight Gain
- Keywords
- Excessive gestational weight gain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- California Polytechnic State University-San Luis Obispo, Women and Infants Hospital of Rhode Island, University of California, Berkeley
- Study start
- Mar 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 May 2010 (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.
Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.
It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| Intervention | Experimental | Behavioral: LifestyleLifestyle intervention delivered during pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- non-smoking, adults,
- < 16 weeks gestation
Key exclusion criteria (1 listed)
- medical comorbidities
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 |
|---|---|---|
| LifestyleBehavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain | Behavioural | Intervention |
Primary outcome
Percentage of women above the Institute of Medicine Guidelines for gestational weight gain
Time frame: 40 weeks
Objective measures of weight collected by trained staff on calibrated scales at study entry and after delivery to classify women as above or below the Institute of Medicine Guidelines for gestational weight gain
1 secondary outcome
Behavioral measures
Time frame: 40 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 1 May 2013.
- Derived from this study: PubMed 28525293Mercado A, Marquez B, Abrams B, Phipps MG, Wing RR, Phelan S. Where Do Women Get Advice About Weight, Eating, and Physical Activity During Pregnancy? J Womens Health (Larchmt). 2017 Sep;26(9):951-956. doi: 10.1089/jwh.2016.6078. Epub 2017 May 19.
- Derived from this study: PubMed 24284438Phelan S, Phipps MG, Abrams B, Darroch F, Grantham K, Schaffner A, Wing RR. Does behavioral intervention in pregnancy reduce postpartum weight retention? Twelve-month outcomes of the Fit for Delivery randomized trial. Am J Clin Nutr. 2014 Feb;99(2):302-11. doi: 10.3945/ajcn.113.070151. Epub 2013 Nov 27.
- Derived from this study: PubMed 21310836Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lifestyle in people with Weight Gain, run by The Miriam Hospital.
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 2 inclusion and 1 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 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (time frame: 40 weeks). 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 NCT01117961, which also lists 3 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 1 May 2013.