Diabetes Mellitus in Pregnancy, Hypertension in Pregnancy, Postpartum Weight Retention, Preeclampsia, Recruitment, Weight Loss
Conditions
Keywords
weight loss, postpartum period, hypertension in pregnancy, cardiovascular risk reduction, diabetes prevention program
Brief summary
The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. The investigators will also be testing different behavioral strategies to recruit postpartum women to the study, including 2 email recruitment strategies and 2 mailer recruitment strategies, informed by behavioral design.
Interventions
BEHAVIORALOnline 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.
BEHAVIORALVirtual 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. Delivered a baby at HUP or PAH within 3-12 months prior to study start; 3. BMI ≥ 27 kg/m2 4. Diagnosis of one of the following medical conditions: chronic hypertension, gestational hypertension, preeclampsia, eclampsia, gestational diabetes, or diabetes mellitus (type 1 or 2) based on diagnosis codes in the EMR 5. Has online access through smartphone or computer and has email address 6. Ability to read and provide informed consent to participate in the study
Exclusion criteria
1. Delivered prior to 32 weeks gestation in the EMR 2. Documentation of fetal demise or neonatal demise in the EMR 3. Currently pregnant or planning to get pregnant within the next 5 months 4. Does not speak English 5. Answers yes to any of the following questions: * Are you currently participating in any other weight loss or physical activity studies? * Do you have any medical conditions or other reasons why you could not participate in a 16-week weight loss or physical activity program? 6. Participants will be excluded after completing the run-in period if they do not complete the daily food log or their baseline BMI is \< 27 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight in Pounds From Baseline to 16-week Follow-up | Baseline and 16 weeks | Mean change in weight in pounds from baseline to 16-week follow-up between study arms. |
| Enrollment Rate Between Email Recruitment Strategies | 8 weeks | We will compare enrollment rates between two behaviorally-framed email strategies |
| Sign-up Rate Between Mailer Recruitment Strategies | 8 weeks | We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift |
| Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up | Baseline and 16 weeks | Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Arm: Number of Weeks With One or More Logins | 16 weeks | Engagement with BWL platform measured by mean number of weeks with one or more logins |
| Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days | 16 weeks | Mean number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days |
| Study Completion Rate Between 2 Arms | 16 weeks | Proportion of participants that completed all follow-up procedures between both study arms. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued study | 4 | 1 |
| Overall Study | Lost to Follow-up | 7 | 0 |
| Overall Study | Pregnancy | 3 | 1 |
Baseline characteristics
| Characteristic | Online Behavioral Weight Loss | Usual Care | Total |
|---|---|---|---|
| Age, Categorical Age <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age Between 18 and 65 years | 40 Participants | 20 Participants | 60 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 5.7 | 32 years STANDARD_DEVIATION 4.2 | 33.1 years STANDARD_DEVIATION 5.3 |
| Chronic hypertension | 8 Participants | 3 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 18 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 10 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 19 Participants | 8 Participants | 27 Participants |
| Region of Enrollment United States | 40 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 40 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 20 | 0 / 89 |
| other Total, other adverse events | 0 / 40 | 0 / 20 | 0 / 89 |
| serious Total, serious adverse events | 0 / 40 | 0 / 20 | 0 / 89 |
Outcome results
Primary
Change in Weight in Pounds From Baseline to 16-week Follow-up
Mean change in weight in pounds from baseline to 16-week follow-up between study arms.
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Online Behavioral Weight Loss | Change in Weight in Pounds From Baseline to 16-week Follow-up | -8.6 pounds |
| Usual Care | Change in Weight in Pounds From Baseline to 16-week Follow-up | -3.3 pounds |
Comparison: Change in weight among participants who completed final assessmentp-value: 0.04895% CI: [0.04, 10.8]Mixed Models Analysis
Primary
Enrollment Rate Between Email Recruitment Strategies
We will compare enrollment rates between two behaviorally-framed email strategies
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Behavioral Weight Loss | Enrollment Rate Between Email Recruitment Strategies | 88 Participants |
| Usual Care | Enrollment Rate Between Email Recruitment Strategies | 102 Participants |
p-value: 0.3Chi-squared
Primary
Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up
Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups.
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Behavioral Weight Loss | Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up | 9 Participants |
| Usual Care | Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up | 3 Participants |
p-value: 0.734Fisher Exact
Primary
Sign-up Rate Between Mailer Recruitment Strategies
We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Behavioral Weight Loss | Sign-up Rate Between Mailer Recruitment Strategies | 11 Participants |
| Usual Care | Sign-up Rate Between Mailer Recruitment Strategies | 16 Participants |
p-value: 0.331Chi-squared
Secondary
Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days
Mean number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Behavioral Weight Loss | Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days | 5.2 weeks | Standard Deviation 4.8 |
Secondary
Intervention Arm: Number of Weeks With One or More Logins
Engagement with BWL platform measured by mean number of weeks with one or more logins
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Behavioral Weight Loss | Intervention Arm: Number of Weeks With One or More Logins | 8.6 weeks | Standard Deviation 5.3 |
Secondary
Study Completion Rate Between 2 Arms
Proportion of participants that completed all follow-up procedures between both study arms.
Time frame: 16 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Online Behavioral Weight Loss | Study Completion Rate Between 2 Arms | Completed follow-up | 26 Participants |
| Online Behavioral Weight Loss | Study Completion Rate Between 2 Arms | Pregnant | 3 Participants |
| Online Behavioral Weight Loss | Study Completion Rate Between 2 Arms | Discontinued intervention | 4 Participants |
| Online Behavioral Weight Loss | Study Completion Rate Between 2 Arms | Lost to follow-up | 7 Participants |
| Usual Care | Study Completion Rate Between 2 Arms | Discontinued intervention | 1 Participants |
| Usual Care | Study Completion Rate Between 2 Arms | Completed follow-up | 18 Participants |
| Usual Care | Study Completion Rate Between 2 Arms | Lost to follow-up | 0 Participants |
| Usual Care | Study Completion Rate Between 2 Arms | Pregnant | 1 Participants |