Obesity, Pregnancy
Conditions
Keywords
obese, pregnant, large for gestational age, large for gestational age baby
Brief summary
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
Interventions
BEHAVIORALWeight Management
Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy
OTHERUsual Care
Standard nutrition counseling from Health Plan
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 30 or more * Less than 20 weeks gestation * member of Kaiser Permanente Northwest (NW) * receive pre-natal care at Kaiser Permanente NW * speaks English
Exclusion criteria
* no current treatment for cancer * no bariatric surgery * no current renal disease * no multiple birth anticipated * no hyperemesis requiring hospitalization * no diabetes (type 1 or 2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Weight Change | baseline to 2 weeks post partum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Weight Change | baseline to 34 weeks gestation | — |
| Large for Gestational Age (LGA) | At birth | Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| 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 | 58 |
| Total | 118 |
Baseline characteristics
| Characteristic | Usual Care | Weight Management Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 58 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 52 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 50 Participants | 101 Participants |
| Region of Enrollment United States | 60 participants | 58 participants | 118 participants |
| Sex: Female, Male Female | 60 Participants | 58 Participants | 118 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 100.5 kg STANDARD_DEVIATION 15.6 | 98.8 kg STANDARD_DEVIATION 15.1 | 99.7 kg STANDARD_DEVIATION 15.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 60 | 30 / 58 |
| serious Total, serious adverse events | 2 / 60 | 0 / 58 |
Outcome results
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.
Time frame: baseline to 2 weeks post partum
Population: Data was from follow up visit or validated clinical data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Maternal Weight Change | 1.2 kg | Standard Deviation 5.6 |
| Weight Management Counseling | Maternal Weight Change | -2.6 kg | Standard Deviation 5.5 |
Secondary
Large for Gestational Age (LGA)
Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.
Time frame: At birth
Population: Babies born to participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Large for Gestational Age (LGA) | 15 participants |
| Weight Management Counseling | Large for Gestational Age (LGA) | 5 participants |
Secondary
Pregnancy Weight Change
Time frame: baseline to 34 weeks gestation
Population: Participants returning for follow up visit or validated clinical data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Pregnancy Weight Change | 8.4 kg | Standard Deviation 4.7 |
| Weight Management Counseling | Pregnancy Weight Change | 5.0 kg | Standard Deviation 4.1 |