Gestational Weight GainNCT02130232
Appropriate Gestational Weight Gain in Overweight/Obese Women
A study testing Lifestyle Intervention in people with Gestational Weight Gain, run by Kaiser Permanente at 2 sites in United States.
Trial summary
The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Weight Gain
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Feb 2020
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant
- Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record)
Who cannot join
- Diabetes
- Cardiovascular disease
- Gastrointestinal disease
- Bariatric surgery
- Lung disease
- Thyroid disease
Show all 12Show fewer
- Eating disorder
- Cancer
- Bed rest or Gestational Diabetes in the current pregnancy
- Planning to get pregnant again or move within 1 year of delivery
- Substance abuse
- Serious mental health disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, 95051
About this study
The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.
- Conditions
- Gestational Weight Gain
- Being tested
- Lifestyle Intervention, Usual Care
- Keywords
- Gestational weight gain, Lifestyle, Intervention
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Usual CareOther
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The pregnancy lifestyle intervention will be delivered by trained study dieticians via individual counseling sessions: 2 in-person and 11 telephone sessions delivered on a weekly basis, followed by telephone sessions delivered every other week through the end of pregnancy. Receives: Behavioral: Lifestyle Intervention |
| Usual Care | Active comparator | Usual Medical Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of gestational weight gain per week
Measured: From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week
Measured: from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Secondary outcomes (11)
Total gestational weight gain
Measured: from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks
Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week
Measured: From pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks
Rate of gestational weight gain between study clinical assessments
Measured: Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week)
Diet - total calories from fat
Measured: Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
Diet - proportion of calories from fat
Measured: Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
Physical Activity
Measured: Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - glycemia
Measured: Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - insulinemia
Measured: Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - lipids
Measured: Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - leptin
Measured: Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - adiponectin
Measured: Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2019
- Study completionFeb 2020
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 Gestational Weight GainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Assiamira Ferrara, MD PhD, Principal investigator, Kaiser Permanente Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130232
- Sponsor's protocol ID
- CN-13-1628
- Other IDs
- 5R01HD073572-02
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2014
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005.
PubMed 34544560Ferrara A, Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Feng J, Galarce M, Marcovina S, Catalano P, Quesenberry CP. A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):490-500. doi: 10.1016/S2213-8587(20)30107-8.
PubMed 32445736Brown SD, Hedderson MM, Ehrlich SF, Galarce MN, Tsai AL, Quesenberry CP, Ferrara A. Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesity. BMC Pregnancy Childbirth. 2019 Apr 30;19(1):145. doi: 10.1186/s12884-019-2293-8.
PubMed 31039753
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Gestational Weight Gain in Overweight/Obese Women
- ClinicalTrials.gov ID
- NCT02130232
- Acronym / sponsor ID
- CN-13-1628
- Conditions
- Gestational Weight Gain
- Keywords
- Gestational weight gain, Lifestyle, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 5 May 2014 (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 goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionThe goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The pregnancy lifestyle intervention will be delivered by trained study dieticians via individual counseling sessions: 2 in-person and 11 telephone sessions delivered on a weekly basis, followed by telephone sessions delivered every other week through the end of pregnancy. |
| Usual Care | Active comparator | Other: Usual CareUsual Medical Care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant
- Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record)
Key exclusion criteria (12 listed)
- Diabetes
- Cardiovascular disease
- Gastrointestinal disease
- Bariatric surgery
- Lung disease
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 |
|---|---|---|
| Lifestyle Intervention | Behavioural | Lifestyle Intervention |
| Usual Care | Other | Usual Care |
Primary outcome
Rate of gestational weight gain per week
Time frame: From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week
Time frame: from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy
11 secondary outcomes
Total gestational weight gain
Time frame: from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks
Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week
Time frame: From pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks
Rate of gestational weight gain between study clinical assessments
Time frame: Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week)
Diet - total calories from fat
Time frame: Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
Diet - proportion of calories from fat
Time frame: Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
Physical Activity
Time frame: Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - glycemia
Time frame: Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - insulinemia
Time frame: Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - lipids
Time frame: Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - leptin
Time frame: Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Metabolic marker - adiponectin
Time frame: Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
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 7 Apr 2020.
- Derived from this study: PubMed 34544560Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005.
- Derived from this study: PubMed 32445736Ferrara A, Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Feng J, Galarce M, Marcovina S, Catalano P, Quesenberry CP. A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):490-500. doi: 10.1016/S2213-8587(20)30107-8.
- Derived from this study: PubMed 31039753Brown SD, Hedderson MM, Ehrlich SF, Galarce MN, Tsai AL, Quesenberry CP, Ferrara A. Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesity. BMC Pregnancy Childbirth. 2019 Apr 30;19(1):145. doi: 10.1186/s12884-019-2293-8.
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Time-restricted Eating Among Pregnant Females With Severe Obesity
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Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
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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.
Assiamira Ferrara, MD PhD principal investigator
Kaiser Permanente Division of Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Gestational Weight Gain, run by Kaiser Permanente 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 2 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 7 Apr 2020. 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.
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?
Rate of gestational weight gain per week (time frame: From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy). 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 NCT02130232, 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 7 Apr 2020.