Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

NCT04914819 | Completed Results

• 2 other identifiers: 8446945K23HL153667-03
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Postpartum Weight Retention; Hypertension in Pregnancy; Diabetes Mellitus in Pregnancy; Preeclampsia; Recruitment

Keywords

weight loss; postpartum period; hypertension in pregnancy; cardiovascular risk reduction; diabetes prevention program

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Study Completion Rate Between 2 Arms

  16 weeks

• Intervention Arm: 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

  16 weeks

Study Arms (2)

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.

Behavioral: Online Behavioral Weight Loss Program; Behavioral: Virtual weigh-in

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.

Behavioral: Virtual weigh-in

Interventions

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.

Online Behavioral Weight Loss

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.

Online Behavioral Weight Loss; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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?
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Weight Loss; Gestational Weight Gain; Hypertension, Pregnancy-Induced; Diabetes, Gestational; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Jennifer Lewey
• Organization: University of Pennsylvania

jennifer.lewey@pennmedicine.upenn.edu

215-662-7700

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 7, 2021
• Study Start: June 18, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 6, 2023
• Results First Posted: July 6, 2023

Record last verified: 2023-06

Locations

US (1)