Trial Outcomes & Findings for Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity (NCT NCT04724330)
NCT ID: NCT04724330
Last Updated: 2026-07-02
Results Overview
Observed difference between weight (lbs) at 37 weeks and baseline first trimester weight, measured prior to 15 weeks gestation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
534 participants
Primary outcome timeframe
At 37 weeks in pregnancy
Results posted on
2026-07-02
Participant Flow
Participants were recruited based on clinical referral at 9 academic and community-based obstetrics practices.
Of 534 pregnant women consented, 384 met the inclusion criteria and were randomized.
Participant milestones
| Measure |
Healthy for Two/Healthy for You (H42/H4U)
Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.
|
Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.
|
|---|---|---|
|
Full Maternal Follow-up Period
STARTED
|
191
|
193
|
|
Full Maternal Follow-up Period
37 Weeks of Gestation
|
187
|
190
|
|
Full Maternal Follow-up Period
COMPLETED
|
187
|
190
|
|
Full Maternal Follow-up Period
NOT COMPLETED
|
4
|
3
|
|
Postpartum Infant Follow-up Period
STARTED
|
187
|
190
|
|
Postpartum Infant Follow-up Period
COMPLETED
|
187
|
187
|
|
Postpartum Infant Follow-up Period
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Healthy for Two/Healthy for You (H42/H4U)
Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.
|
Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.
|
|---|---|---|
|
Full Maternal Follow-up Period
Physician Decision
|
4
|
3
|
|
Postpartum Infant Follow-up Period
Death
|
0
|
1
|
|
Postpartum Infant Follow-up Period
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity
Baseline characteristics by cohort
| Measure |
Healthy for Two/Healthy for You (H42/H4U)
n=187 Participants
Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.
|
Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)
n=190 Participants
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 4.9 • n=20 Participants
|
32.7 years
STANDARD_DEVIATION 5.0 • n=20 Participants
|
32.8 years
STANDARD_DEVIATION 5.0 • n=40 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=20 Participants
|
190 Participants
n=20 Participants
|
377 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
176 Participants
n=20 Participants
|
164 Participants
n=20 Participants
|
340 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=20 Participants
|
54 Participants
n=20 Participants
|
114 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=20 Participants
|
100 Participants
n=20 Participants
|
205 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Body Mass Index (BMI)
25-29.9
|
67 Participants
n=20 Participants
|
67 Participants
n=20 Participants
|
134 Participants
n=40 Participants
|
|
Body Mass Index (BMI)
30-39.9
|
86 Participants
n=20 Participants
|
95 Participants
n=20 Participants
|
181 Participants
n=40 Participants
|
|
Body Mass Index (BMI)
>= 40
|
34 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Participant Prenatal recruitment practices
Hospital-affiliated faculty practice
|
91 Participants
n=20 Participants
|
90 Participants
n=20 Participants
|
181 Participants
n=40 Participants
|
|
Participant Prenatal recruitment practices
Community-based practice
|
90 Participants
n=20 Participants
|
89 Participants
n=20 Participants
|
179 Participants
n=40 Participants
|
|
Participant Prenatal recruitment practices
Federal qualified health center practice
|
6 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: At 37 weeks in pregnancyPopulation: Complete cases from the intention-to-treat population (all participants randomized to H42/H4U or mHIP with non-missing outcome data) at 37 weeks of gestation.
Observed difference between weight (lbs) at 37 weeks and baseline first trimester weight, measured prior to 15 weeks gestation.
Outcome measures
| Measure |
Healthy for Two/Healthy for You (H42/H4U)
n=177 Participants
Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.
|
Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)
n=176 Participants
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.
|
|---|---|---|
|
Observed Total Gestational Weight Gain
|
22.4 lb
Standard Deviation 13.7
|
22.2 lb
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: At 37 weeks in pregnancyPopulation: Complete cases from the intention-to-treat population (all participants randomized to H42/H4U or mHIP with non-missing outcome data) at 37 weeks of gestation.
Defined and validated by electronic health record diagnosis.
Outcome measures
| Measure |
Healthy for Two/Healthy for You (H42/H4U)
n=187 Participants
Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.
|
Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)
n=188 Participants
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.
|
|---|---|---|
|
Observed Incidence of Gestational Diabetes Mellitus
|
27 Participants
|
22 Participants
|
Adverse Events
Healthy for Two/Healthy for You (H42/H4U)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Healthy for Two/Healthy for You (H42/H4U)
n=374 participants at risk
Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.
|
Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)
n=380 participants at risk
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Very pre-term infant at 24 weeks gestation
|
0.27%
1/374 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
0.00%
0/380 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta previa and postpartum hemorrhage
|
0.27%
1/374 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
0.00%
0/380 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
|
Pregnancy, puerperium and perinatal conditions
Intrauterine fetal death at 37 weeks gestation
|
0.00%
0/374 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
0.26%
1/380 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
|
Pregnancy, puerperium and perinatal conditions
Congenital heart defects in infant
|
0.27%
1/374 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
0.00%
0/380 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
Other adverse events
| Measure |
Healthy for Two/Healthy for You (H42/H4U)
n=374 participants at risk
Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.
|
Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)
n=380 participants at risk
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
ER visits, hospitalizations or other events requiring medical evaluation
|
6.4%
24/374 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
6.3%
24/380 • Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place