OverweightNCT02346162
PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention
A study testing Weight management in people with Overweight and Obese, run by Kaiser Permanente at 1 site in United States.
Trial summary
The US obesity epidemic is being transmitted to the next generation. Growing evidence suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during pregnancy, are associated with increased risk of pregnancy-related complications such as gestational diabetes and pre-eclampsia, and an… 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
- Overweight, Obese
- What is being tested?
- Weight management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 21 Jun 2019
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current Kaiser Permanente Northwest (KPNW) member
- Expects to be KPNW member for at least 2 more years
- Body Mass Index (BMI) ≥ 27
- Not currently pregnant
- Access to computer with Internet
- Completion of screening diet assessment
- English speaking
Who cannot join
- Taking medication (insulin or pills) for treatment of diabetes
- Gastrointestinal disease requiring special diet or medications (for example, ulcerative colitis, celiac sprue, phenylketonuria)
- Currently receiving treatment for cancer
- Renal disease (kidney disease requiring special diet or medication)
- History of bariatric surgery
- Use of prescription weight loss medications in the last three months
- Another household member already participating in the Prepare study
Trial locations and contacts
1 site in 1 country.
About this study
The US obesity epidemic is being transmitted to the next generation. Growing evidence suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during pregnancy, are associated with increased risk of pregnancy-related complications such as gestational diabetes and pre-eclampsia, and an increased risk that her child will become obese and face obesity-related health issues in later life.
Currently, over one-third of reproductive-aged women in the U.S. are obese [body mass index (BMI) ≥ 30]. Our research team has shown that we can improve birth weight outcomes in babies of obese women who start a weight-management intervention program at 14 to 15 weeks of their pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. Therefore, waiting to address mothers' weight, physical activity, and diet quality until the first prenatal visit is not optimal. Given the need to reach overweight and obese women prior to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on observational studies, that women should reach a healthy weight before conceiving, this randomized clinical trial will evaluate a comprehensive preconception weight loss program.
Read the detailed description
The goals are to help overweight and obese women (BMI ≥ 27) who are considering pregnancy to adopt improved dietary and physical activity habits and lose weight prior to becoming pregnant, and then help them maintain those habits and prevent excessive weight gain during their pregnancy. We model this intervention after successful, frequent-contact interventions designed by ourselves and other investigators. We start with face-to-face counseling followed by frequent telephone counseling contacts. The expected outcomes for mothers include reduced pregnancy-related weight gain (primary) and lower weight at the start of pregnancy (secondary) and for babies, decreased risk of exceeding national norms for weight at birth (secondary).
- Conditions
- Overweight, Obese
- Being tested
- Weight management, Usual Care Control
- Keywords
- Pre-pregnancy, Weight management
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight managementBehavioural
Phone counseling for pre-pregnancy weight loss and weight maintenance when BMI </=25, and when pregnant, weight gain within IOM guidelines.
Usual Care ControlOther
Usual care control participants receive general dietary advice as it relates to planning for a healthy pregnancy (e.g. folate requirements, prenatal vitamins, smoking cessation, alcohol cessation, and prenatal food safety).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Weight management intervention Receives: Behavioral: Weight management |
| Usual Care Control | Other | Usual Care for planning healthy pregnancy Receives: Other: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced pregnancy-related weight gain
Measured: 1 day at the end of pregnancy
Secondary outcomes (2)
Lower weight at the start of pregnancy
Measured: Self-reported pre-pregnancy weight supplemented by weight at first prenatal visit (1 day)
Decreased risk of exceeding national norms for weight at birth
Measured: birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJun 2015
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
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 OverweightStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin S LeBlanc, MD, Principal investigator, Center for Health Research, Kaiser Permanente NorthwestVictor J Stevens, PhD, Principal investigator, Center for Health Research, Kaiser Permanente Northwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346162
- Sponsor's protocol ID
- R01DK099882
- Other IDs
- R01DK099882
- Status last verified
- Apr 2022
- First submitted
- 20 Jan 2015
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Any information from this study we present in reports or publications will not identify any individual.
Publications
LeBlanc ES, Smith NX, Vesco KK, Paul IM, Stevens VJ. Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial. Am J Obstet Gynecol. 2021 Jan;224(1):99.e1-99.e14. doi: 10.1016/j.ajog.2020.07.027. Epub 2020 Jul 18.
PubMed 32687819LeBlanc ES, Boisvert C, Catlin C, Lee MH, Smith N, Vesco KK, Savage J, Mitchell DC, Gruss I, Stevens VJ. Prepare randomized clinical trial: Acceptability, engagement, and lifestyle effects of a weight loss intervention beginning in pre-pregnancy. Obes Sci Pract. 2022 Feb 24;8(5):603-616. doi: 10.1002/osp4.596. eCollection 2022 Oct.
PubMed 36238226LeBlanc ES, Smith NX, Vesco KK, Hillier TA, Stevens VJ. Weight Loss Prior to Pregnancy and Early Gestational Glycemia: Prepare, a Randomized Clinical Trial. J Clin Endocrinol Metab. 2021 Nov 19;106(12):e5001-e5010. doi: 10.1210/clinem/dgab547.
PubMed 34313765
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention
- ClinicalTrials.gov ID
- NCT02346162
- Acronym / sponsor ID
- R01DK099882
- Conditions
- Overweight, Obese
- Keywords
- Pre-pregnancy, Weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2015
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 26 Jan 2015 (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 US obesity epidemic is being transmitted to the next generation. Growing evidence suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during pregnancy, are associated with increased risk of pregnancy-related complications such as gestational diabetes and pre-eclampsia, and an increased risk that her child will become obese and face obesity-related health issues in later life.
Currently, over one-third of reproductive-aged women in the U.S. are obese [body mass index (BMI) ≥ 30]. Our research team has shown that we can improve birth weight outcomes in babies of obese women who start a weight-management intervention program at 14 to 15 weeks of their pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. Therefore, waiting to address mothers' weight, physical activity, and diet quality until the first prenatal visit is not optimal. Given the need to reach overweight and obese women prior to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on observational studies, that women should reach a healthy weight before conceiving, this randomized clinical trial will evaluate a comprehensive preconception weight loss program.
Detailed description
The goals are to help overweight and obese women (BMI ≥ 27) who are considering pregnancy to adopt improved dietary and physical activity habits and lose weight prior to becoming pregnant, and then help them maintain those habits and prevent excessive weight gain during their pregnancy. We model this intervention after successful, frequent-contact interventions designed by ourselves and other investigators. We start with face-to-face counseling followed by frequent telephone counseling contacts. The expected outcomes for mothers include reduced pregnancy-related weight gain (primary) and lower weight at the start of pregnancy (secondary) and for babies, decreased risk of exceeding national norms for weight at birth (secondary).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Weight managementWeight management intervention |
| Usual Care Control | Other | Other: Usual Care ControlUsual Care for planning healthy pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Current Kaiser Permanente Northwest (KPNW) member
- Expects to be KPNW member for at least 2 more years
- Body Mass Index (BMI) ≥ 27
- Not currently pregnant
- Access to computer with Internet
Key exclusion criteria (7 listed)
- Taking medication (insulin or pills) for treatment of diabetes
- Gastrointestinal disease requiring special diet or medications (for example, ulcerative colitis, celiac sprue, phenylketonuria)
- Currently receiving treatment for cancer
- Renal disease (kidney disease requiring special diet or medication)
- History of bariatric surgery
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 |
|---|---|---|
| Weight managementPhone counseling for pre-pregnancy weight loss and weight maintenance when BMI </=25, and when pregnant, weight gain within IOM guidelines. | Behavioural | Intervention |
| Usual Care ControlUsual care control participants receive general dietary advice as it relates to planning for a healthy pregnancy (e.g. folate requirements, prenatal vitamins, smoking cessation, alcohol cessation, and prenatal food safety). | Other | Usual Care Control |
Primary outcome
Reduced pregnancy-related weight gain
Time frame: 1 day at the end of pregnancy
2 secondary outcomes
Lower weight at the start of pregnancy
Time frame: Self-reported pre-pregnancy weight supplemented by weight at first prenatal visit (1 day)
Decreased risk of exceeding national norms for weight at birth
Time frame: birth
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 5 Apr 2022.
- Results publication: PubMed 32687819LeBlanc ES, Smith NX, Vesco KK, Paul IM, Stevens VJ. Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial. Am J Obstet Gynecol. 2021 Jan;224(1):99.e1-99.e14. doi: 10.1016/j.ajog.2020.07.027. Epub 2020 Jul 18.
- Derived from this study: PubMed 36238226LeBlanc ES, Boisvert C, Catlin C, Lee MH, Smith N, Vesco KK, Savage J, Mitchell DC, Gruss I, Stevens VJ. Prepare randomized clinical trial: Acceptability, engagement, and lifestyle effects of a weight loss intervention beginning in pre-pregnancy. Obes Sci Pract. 2022 Feb 24;8(5):603-616. doi: 10.1002/osp4.596. eCollection 2022 Oct.
- Derived from this study: PubMed 34313765LeBlanc ES, Smith NX, Vesco KK, Hillier TA, Stevens VJ. Weight Loss Prior to Pregnancy and Early Gestational Glycemia: Prepare, a Randomized Clinical Trial. J Clin Endocrinol Metab. 2021 Nov 19;106(12):e5001-e5010. doi: 10.1210/clinem/dgab547.
- Individual participant dataSharing planned: No. Any information from this study we present in reports or publications will not identify any individual.
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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.
Erin S LeBlanc, MD principal investigator
Center for Health Research, Kaiser Permanente Northwest
Victor J Stevens, PhD principal investigator
Center for Health Research, Kaiser Permanente Northwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight management in people with Overweight and Obese, run by Kaiser Permanente 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 7 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 5 Apr 2022. 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?
Reduced pregnancy-related weight gain (time frame: 1 day at the end of pregnancy). 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 NCT02346162, 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 5 Apr 2022.