CompletedNot Applicable

Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

United States89 participantsStarted 2021-06-18

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥18 years;
✓. Delivered a baby at HUP or PAH within 3-12 months prior to study start;
✓. BMI ≥ 27 kg/m2
✓. 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
✓. Has online access through smartphone or computer and has email address
✓. Ability to read and provide informed consent to participate in the study

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

What they're measuring

Change in Weight in Pounds From Baseline to 16-week Follow-up

Timeframe: Baseline and 16 weeks

Enrollment Rate Between Email Recruitment Strategies

Timeframe: 8 weeks

Sign-up Rate Between Mailer Recruitment Strategies

Timeframe: 8 weeks

Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up

Timeframe: Baseline and 16 weeks

Trial details

NCT IDNCT04914819

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Results submitted2023-02-06

View on ClinicalTrials.gov More Weight Loss trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥18 years;
✓. Delivered a baby at HUP or PAH within 3-12 months prior to study start;
✓. BMI ≥ 27 kg/m2
✓. 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
✓. Has online access through smartphone or computer and has email address
✓. Ability to read and provide informed consent to participate in the study

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

What they're measuring

Change in Weight in Pounds From Baseline to 16-week Follow-up

Timeframe: Baseline and 16 weeks

Enrollment Rate Between Email Recruitment Strategies

Timeframe: 8 weeks

Sign-up Rate Between Mailer Recruitment Strategies

Timeframe: 8 weeks

Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up

Timeframe: Baseline and 16 weeks