Trial Outcomes & Findings for Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy (NCT NCT03707834)
NCT ID: NCT03707834
Last Updated: 2026-01-21
Results Overview
Excessive weight gain is defined as the percentage of mothers exceeding weekly IOM weight gain targets (\>0.32 kg/week for BMI 25-29.9 kg/m2; \>0.27 kg/week for BMI ≥30 kg/m2) over the study period (from enrollment to end of pregnancy).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
416 participants
Primary outcome timeframe
End of Pregnancy (36-38 weeks' gestation)
Results posted on
2026-01-21
Participant Flow
Participant milestones
| Measure |
Antenatal Obesity Treatment (AO)
The AO arm consists of a multi-component, theory- and evidence-based intervention and includes weight-related behavior change through goal setting and self-monitoring, behavioral skills training, interpersonal support, and social modeling strategies.
Antenatal Obesity Treatment (AO): Participants in the treatment (AO) arm will receive a 4-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; and 4)WIC provider counseling
Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
|
WIC Standard Care (SC)
Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC.
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
207
|
|
Overall Study
COMPLETED
|
197
|
196
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
Baseline characteristics by cohort
| Measure |
WIC Standard Care (SC)
n=207 Participants
Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC.
|
Antenatal Obesity Treatment (AO)
n=209 Participants
The AO arm consists of a multi-component, theory- and evidence-based intervention and includes weight-related behavior change through goal setting and self-monitoring, behavioral skills training, interpersonal support, and social modeling strategies.
Antenatal Obesity Treatment (AO): Participants in the treatment (AO) arm will receive a 4-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; and 4)WIC provider counseling
Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 5.6 • n=37 Participants
|
29.2 years
STANDARD_DEVIATION 5.6 • n=44 Participants
|
29.4 years
STANDARD_DEVIATION 5.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
207 Participants
n=37 Participants
|
209 Participants
n=44 Participants
|
416 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
70 Participants
n=37 Participants
|
66 Participants
n=44 Participants
|
136 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=37 Participants
|
143 Participants
n=44 Participants
|
280 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
144 Participants
n=37 Participants
|
148 Participants
n=44 Participants
|
292 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=37 Participants
|
5 Participants
n=44 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
59 Participants
n=37 Participants
|
56 Participants
n=44 Participants
|
115 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
207 Participants
n=37 Participants
|
209 Participants
n=44 Participants
|
416 Participants
n=40 Participants
|
|
BMI, Categorical: 25-29.9 kg/m^2 (with overweight); >=30 kg/m2 (with obesity)
BMI >=30 kg/m^2 (with obesity)
|
155 Participants
n=37 Participants
|
152 Participants
n=44 Participants
|
307 Participants
n=40 Participants
|
|
BMI, Categorical: 25-29.9 kg/m^2 (with overweight); >=30 kg/m2 (with obesity)
BMI 25-29.9 kg/m^2 (with overweight)
|
52 Participants
n=37 Participants
|
57 Participants
n=44 Participants
|
109 Participants
n=40 Participants
|
|
Parity: Nulliparous, Primi- & Multiparous
Nulliparous
|
53 Participants
n=37 Participants
|
74 Participants
n=44 Participants
|
127 Participants
n=40 Participants
|
|
Parity: Nulliparous, Primi- & Multiparous
Primi- & Multiparous
|
154 Participants
n=37 Participants
|
135 Participants
n=44 Participants
|
289 Participants
n=40 Participants
|
|
Education: More than High School, High School and Below
More than High School
|
95 Participants
n=37 Participants
|
98 Participants
n=44 Participants
|
193 Participants
n=40 Participants
|
|
Education: More than High School, High School and Below
High School and Below
|
112 Participants
n=37 Participants
|
111 Participants
n=44 Participants
|
223 Participants
n=40 Participants
|
|
Gestational Age, Continuous
|
15.4 weeks
STANDARD_DEVIATION 2.5 • n=37 Participants
|
15.4 weeks
STANDARD_DEVIATION 2.4 • n=44 Participants
|
15.4 weeks
STANDARD_DEVIATION 2.4 • n=40 Participants
|
PRIMARY outcome
Timeframe: End of Pregnancy (36-38 weeks' gestation)Excessive weight gain is defined as the percentage of mothers exceeding weekly IOM weight gain targets (\>0.32 kg/week for BMI 25-29.9 kg/m2; \>0.27 kg/week for BMI ≥30 kg/m2) over the study period (from enrollment to end of pregnancy).
Outcome measures
| Measure |
WIC Standard Care (SC)
n=196 Participants
Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC.
|
Antenatal Obesity Treatment (AO)
n=197 Participants
The AO arm consists of a multi-component, theory- and evidence-based intervention and includes weight-related behavior change through goal setting and self-monitoring, behavioral skills training, interpersonal support, and social modeling strategies.
Antenatal Obesity Treatment (AO): Participants in the treatment (AO) arm will receive a 4-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; and 4)WIC provider counseling
Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
|
|---|---|---|
|
Percentage of Women With Excessive Gestational Weight Gain
|
126 Participants
|
119 Participants
|
PRIMARY outcome
Timeframe: At baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation)Weight gain will be calculated as the difference between weight in kilograms measured at 36-38 weeks' gestation and baseline weight.
Outcome measures
| Measure |
WIC Standard Care (SC)
n=196 Participants
Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC.
|
Antenatal Obesity Treatment (AO)
n=197 Participants
The AO arm consists of a multi-component, theory- and evidence-based intervention and includes weight-related behavior change through goal setting and self-monitoring, behavioral skills training, interpersonal support, and social modeling strategies.
Antenatal Obesity Treatment (AO): Participants in the treatment (AO) arm will receive a 4-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; and 4)WIC provider counseling
Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
|
|---|---|---|
|
Change in Maternal Weight
|
7.6 kilograms
Interval 4.0 to 11.5
|
7.2 kilograms
Interval 4.0 to 11.4
|
SECONDARY outcome
Timeframe: Baseline and 36-38 weeks' gestationWill be measured using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool, a web application developed by NCI. We will collect 3 separate 24-hour dietary recalls (1 weekend day, 2 weekdays) at baseline and 36-38 weeks' gestation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DeliveryEvaluated via medical record abstraction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DeliveryEvaluated via medical record abstraction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6-month PPWeight change will be calculated as the difference between mean 6-month PP weight and baseline weight in kilograms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 12-month PPWeight change will be calculated as the difference between mean 12-month PP weight and baseline weight in kilograms.
Outcome measures
Outcome data not reported
Adverse Events
WIC Standard Care (SC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antenatal Obesity Treatment (AO)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sharon J. Herring, MD, MPH, Principal Investigator
Temple University
Phone: 215-707-2234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place