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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD058061 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other | This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group |
|
| Weight Management Counseling | Experimental | In-person and group session counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Management | Behavioral | Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Weight Change | We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain. | baseline to 2 weeks post partum |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Weight Change | baseline to 34 weeks gestation | |
| Large for Gestational Age (LGA) | Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor J Stevens, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Center for Health Research | Portland | Oregon | 97227 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25164259 | Derived | Vesco KK, Karanja N, King JC, Gillman MW, Leo MC, Perrin N, McEvoy CT, Eckhardt CL, Smith KS, Stevens VJ. Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial. Obesity (Silver Spring). 2014 Sep;22(9):1989-96. doi: 10.1002/oby.20831. | |
| 22465256 | Derived | Vesco KK, Karanja N, King JC, Gillman MW, Perrin N, McEvoy C, Eckhardt C, Smith KS, Stevens VJ. Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale. Contemp Clin Trials. 2012 Jul;33(4):777-85. doi: 10.1016/j.cct.2012.03.006. Epub 2012 Mar 20. |
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Women were invited to attend an informational meeting which explained the study and covered the elements of consent. Interested volunteers were asked to come back to the research setting for the baseline visit. Randomization occurred at the baseline visit after a final review of eligibility and signing a consent.
English speaking, obese, age 18 or older receiving pregnancy care at an prepaid health plan clinic. Less than 21 weeks gestation. Recruitment November 2009-July 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group Usual Care: Standard nutrition counseling from Health Plan |
| FG001 | Weight Management Counseling | In-person and group session counseling Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group Usual Care: Standard nutrition counseling from Health Plan |
| BG001 | Weight Management Counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Weight Change | We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain. | Data was from follow up visit or validated clinical data | Posted | Mean | Standard Deviation | kg | baseline to 2 weeks post partum |
|
AE data collected at follow up visits (34wk gestation, 2 weeks post-partum, 6 and 12 months post partum)
AE data collected between November 2009 and July 2011, 20 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group Usual Care: Standard nutrition counseling from Health Plan |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cesarean Section | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victor J. Stevens, PhD Principle Investigator | Kaiser Permanente Center for Health Research | 503 335 6751 | victor.j.stevens@kpchr.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Care | Other | Standard nutrition counseling from Health Plan |
|
| At birth |
In-person and group session counseling Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
In-person and group session counseling
Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy
|
|
| Secondary | Pregnancy Weight Change | Participants returning for follow up visit or validated clinical data | Posted | Mean | Standard Deviation | kg | baseline to 34 weeks gestation |
|
|
|
| Secondary | Large for Gestational Age (LGA) | Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth. | Babies born to participants | Posted | Number | participants | At birth |
|
|
|
| 2 |
| 60 |
| 40 |
| 60 |
| EG001 | Weight Management Counseling | In-person and group session counseling Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy | 0 | 58 | 30 | 58 |
| Pre-Term Birth <37 weeks | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| NICU admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Respiratory morbidity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |