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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL153667-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Behavioral Weight Loss | Active Comparator | 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. |
|
| Usual Care | Active Comparator | Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Behavioral Weight Loss Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 16 weeks |
| Enrollment Rate Between Email Recruitment Strategies | We will compare enrollment rates between two behaviorally-framed email strategies | 8 weeks |
| Sign-up Rate Between Mailer Recruitment Strategies | We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift | 8 weeks |
| 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. | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Study Completion Rate Between 2 Arms | Proportion of participants that completed all follow-up procedures between both study arms. | 16 weeks |
| Intervention Arm: Number of Weeks With One or More Logins |
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Inclusion Criteria:
Exclusion Criteria:
Delivered prior to 32 weeks gestation in the EMR
Documentation of fetal demise or neonatal demise in the EMR
Currently pregnant or planning to get pregnant within the next 5 months
Does not speak English
Answers yes to any of the following questions:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | pounds | Baseline and 16 weeks |
|
1-week behavioral run-in plus 16 weeks intervention
Standard definitions were used
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Lewey | University of Pennsylvania | 215-662-7700 | jennifer.lewey@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2021 | Jun 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D000078064 | Gestational Weight Gain |
| D046110 | Hypertension, Pregnancy-Induced |
| D016640 | Diabetes, Gestational |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Virtual weigh-in | Behavioral | 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. |
|
Engagement with BWL platform measured by mean number of weeks with one or more logins
| 16 weeks |
| 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 | 16 weeks |
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Chronic hypertension | Count of Participants | Participants |
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| OG001 | 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. |
|
|
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| Primary | Enrollment Rate Between Email Recruitment Strategies | We will compare enrollment rates between two behaviorally-framed email strategies | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
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| Primary | Sign-up Rate Between Mailer Recruitment Strategies | We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift | 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. | Posted | Count of Participants | Participants | 8 weeks |
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| 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. | Posted | Count of Participants | Participants | Baseline and 16 weeks |
|
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|
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| Secondary | Study Completion Rate Between 2 Arms | Proportion of participants that completed all follow-up procedures between both study arms. | Posted | Count of Participants | Participants | 16 weeks |
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| 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 | Posted | Mean | Standard Deviation | weeks | 16 weeks |
|
|
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| 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 | Posted | Mean | Standard Deviation | weeks | 16 weeks |
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|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Run-In Phase | Participants who provide consent will be asked to complete a 7 day "run-in phase" where they are asked to track their meals daily in the online meal tracker app or on paper. After completing this period, participants are eligible to be randomized. | 0 | 89 | 0 | 89 | 0 | 89 |
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| D015430 | Weight Gain |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Pregnant |
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| Lost to follow-up |
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