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Clinical Trials/NCT02448563
NCT02448563
Completed
Not Applicable

Reducing Obesity in Underserved Postpartum African American Women

Boston Medical Center0 sites128 target enrollmentAugust 2011
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Boston Medical Center
Enrollment
128
Primary Endpoint
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based weight loss program to reduce obesity among postpartum African American (AA) adult women that can be integrated into a postpartum care model within a clinical setting.

Detailed Description

The investigators proposal adapts The Diabetes Prevention Program (DPP) 16 session core curriculum to our 8 session model and in addition uses the cultural tailoring techniques of the DPP to address the needs of our AA population in several ways: 1) The reference materials and lesson handouts include information about the types of foods and cooking methods used by an AA culture (see Other Study Documents); 2) Topics are selected for group classes that are most appropriate for our participants such as Hip Hop or Salsa dancing for physical activity. Participants will be randomized during the early postpartum period to either usual care or intervention. Usual care participants will be offered the weight management standard of care which is one visit with a dietitian in the Nutrition and Weight Management Center. Intervention participants will be assigned a Birth Sister for the postpartum period. They will also attend 8 weekly sessions for the weight loss program. All participants will complete study assessment visits at 6 weeks postpartum and 15 weeks postpartum.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
September 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Caroline Apovian

Professor of Medicine and Pediatrics

Boston Medical Center

Eligibility Criteria

Inclusion Criteria

  • Pre-Natal:
  • BMI greater than or equal to 25
  • Ready to change (classified as answering yes to: Are you seriously considering trying to lose weight to reach your goal in the next 6 months?)
  • English-speaking
  • Post-partum:
  • Live birth (based on medical record review)

Exclusion Criteria

  • Pre-Natal:
  • Signs of moderate to severe depression based on the Patient Health Questionnaire-9 (PHQ-9)
  • Previous enrollment in the Birth Sister's program prior to the study
  • Post-partum:
  • Signs of moderate to severe post-partum depression based on the Edinburgh Postnatal Depression Scale (EPDS)

Outcomes

Primary Outcomes

Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)

Time Frame: Weekly up to 8 weeks

Secondary Outcomes

  • Waist Circumference at 8 Weeks(8 weeks)
  • Change From Baseline Weight to 8 Weeks(Baseline and 8 weeks)
  • Participant Satisfaction as Measured by Questionnaire and Exit Interview(8 weeks)
  • Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire(Baseline and 8 weeks)
  • Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire(Baseline and 8 weeks)
  • Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale(Baseline and 8 weeks)

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