Trial Outcomes & Findings for Weight Management for Improved Pregnancy Outcomes (NCT NCT00950235)
NCT ID: NCT00950235
Last Updated: 2015-07-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
baseline to 2 weeks post partum
Results posted on
2015-07-09
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
58
|
|
Overall Study
COMPLETED
|
58
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weight Management for Improved Pregnancy Outcomes
Baseline characteristics by cohort
| Measure |
Usual Care
n=60 Participants
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
|
Weight Management Counseling
n=58 Participants
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
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Weight
|
100.5 kg
STANDARD_DEVIATION 15.6 • n=5 Participants
|
98.8 kg
STANDARD_DEVIATION 15.1 • n=7 Participants
|
99.7 kg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 2 weeks post partumPopulation: Data was from follow up visit or validated clinical data
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.
Outcome measures
| Measure |
Usual Care
n=58 Participants
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
|
Weight Management Counseling
n=56 Participants
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
|
|---|---|---|
|
Maternal Weight Change
|
1.2 kg
Standard Deviation 5.6
|
-2.6 kg
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: baseline to 34 weeks gestationPopulation: Participants returning for follow up visit or validated clinical data
Outcome measures
| Measure |
Usual Care
n=58 Participants
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
|
Weight Management Counseling
n=56 Participants
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
|
|---|---|---|
|
Pregnancy Weight Change
|
8.4 kg
Standard Deviation 4.7
|
5.0 kg
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: At birthPopulation: Babies born to participants
Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.
Outcome measures
| Measure |
Usual Care
n=58 Participants
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
|
Weight Management Counseling
n=56 Participants
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
|
|---|---|---|
|
Large for Gestational Age (LGA)
|
15 participants
|
5 participants
|
Adverse Events
Usual Care
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Weight Management Counseling
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=60 participants at risk
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
|
Weight Management Counseling
n=58 participants at risk
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
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
3.3%
2/60 • Number of events 2 • 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
|
0.00%
0/58 • 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
|
Other adverse events
| Measure |
Usual Care
n=60 participants at risk
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
|
Weight Management Counseling
n=58 participants at risk
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
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Cesarean Section
|
43.3%
26/60 • Number of events 26 • 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
|
36.2%
21/58 • Number of events 21 • 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
|
|
Pregnancy, puerperium and perinatal conditions
Pre-Term Birth <37 weeks
|
1.7%
1/60 • Number of events 1 • 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
|
6.9%
4/58 • Number of events 4 • 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
|
|
Pregnancy, puerperium and perinatal conditions
NICU admission
|
10.0%
6/60 • Number of events 6 • 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
|
3.4%
2/58 • Number of events 2 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory morbidity
|
11.7%
7/60 • Number of events 7 • 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
|
5.2%
3/58 • Number of events 3 • 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
|
Additional Information
Victor J. Stevens, PhD Principle Investigator
Kaiser Permanente Center for Health Research
Phone: 503 335 6751
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place