Trial Outcomes & Findings for Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (NCT NCT04914819)
NCT ID: NCT04914819
Last Updated: 2023-07-06
Results Overview
Mean change in weight in pounds from baseline to 16-week follow-up between study arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
Baseline and 16 weeks
Results posted on
2023-07-06
Participant Flow
1,047 participants were invited to participate in the study. Potentially eligible participants were recruited from the electronic health record and were sent an email invitation (n=1,000). Potentially eligible participants who did not respond to email recruitment and those who did not have an email address also received a mailer recruitment letter (n=849).
190 individuals signed up for an info session. Of the 190, 115 attended the info session. Excluded: 75 individuals did not attend info session. Of the 115, 89 provided consent and enrolled in run-in period. Excluded: 26 individuals who did not provide consent. Of the 89 enrolled, 60 completed run-in period and were randomized to one of two arms. Note: 27 people signed up for an info session after receiving a recruitment mailer but were excluded due to recruitment goals being met.
Participant milestones
| Measure |
Online Behavioral Weight Loss
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
26
|
18
|
|
Overall Study
NOT COMPLETED
|
14
|
2
|
Reasons for withdrawal
| Measure |
Online Behavioral Weight Loss
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Overall Study
Pregnancy
|
3
|
1
|
|
Overall Study
Discontinued study
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
0
|
Baseline Characteristics
Postpartum Weight Loss for Women at Elevated Cardiovascular Risk
Baseline characteristics by cohort
| Measure |
Online Behavioral Weight Loss
n=40 Participants
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
n=20 Participants
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
40 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 5.7 • n=39 Participants
|
32 years
STANDARD_DEVIATION 4.2 • n=41 Participants
|
33.1 years
STANDARD_DEVIATION 5.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
55 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=39 Participants
|
20 participants
n=41 Participants
|
60 participants
n=35 Participants
|
|
Chronic hypertension
|
8 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksMean change in weight in pounds from baseline to 16-week follow-up between study arms.
Outcome measures
| Measure |
Online Behavioral Weight Loss
n=40 Participants
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
n=20 Participants
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Change in Weight in Pounds From Baseline to 16-week Follow-up
|
-8.6 pounds
Interval -12.1 to -5.3
|
-3.3 pounds
Interval -7.3 to -0.9
|
PRIMARY outcome
Timeframe: 8 weeksWe will compare enrollment rates between two behaviorally-framed email strategies
Outcome measures
| Measure |
Online Behavioral Weight Loss
n=497 Participants
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
n=503 Participants
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Enrollment Rate Between Email Recruitment Strategies
|
88 Participants
|
102 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: A total of 849 patients were randomized to one of two mailer strategies. Participants were eligible for randomization if they met eligibility criteria in the EHR and did not respond to the email invitation (either signed up for information session or declined invitation). They were also eligible for randomization if they had a mailing address but did not have an email address on file.
We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift
Outcome measures
| Measure |
Online Behavioral Weight Loss
n=424 Participants
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
n=425 Participants
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Sign-up Rate Between Mailer Recruitment Strategies
|
11 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksProportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups.
Outcome measures
| Measure |
Online Behavioral Weight Loss
n=40 Participants
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
n=20 Participants
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 16 weeksProportion of participants that completed all follow-up procedures between both study arms.
Outcome measures
| Measure |
Online Behavioral Weight Loss
n=40 Participants
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
n=20 Participants
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Study Completion Rate Between 2 Arms
Completed follow-up
|
26 Participants
|
18 Participants
|
|
Study Completion Rate Between 2 Arms
Discontinued intervention
|
4 Participants
|
1 Participants
|
|
Study Completion Rate Between 2 Arms
Pregnant
|
3 Participants
|
1 Participants
|
|
Study Completion Rate Between 2 Arms
Lost to follow-up
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16 weeksEngagement with BWL platform measured by mean number of weeks with one or more logins
Outcome measures
| Measure |
Online Behavioral Weight Loss
n=40 Participants
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Intervention Arm: Number of Weeks With One or More Logins
|
8.6 weeks
Standard Deviation 5.3
|
—
|
SECONDARY outcome
Timeframe: 16 weeksMean number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days
Outcome measures
| Measure |
Online Behavioral Weight Loss
n=40 Participants
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Online Behavioral Weight Loss Program: Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
Usual Care
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Virtual weigh-in: Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
|
|---|---|---|
|
Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days
|
5.2 weeks
Standard Deviation 4.8
|
—
|
Adverse Events
Online Behavioral Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Run-In Phase
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place