Clinical trial NCT02448563: Reducing Obesity in Underserved Postpartum African American Women
Official title: Reducing Obesity in Underserved Postpartum African American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Pregnancy
African American
Weight Management Program
Behavioral Modifications
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-05-19
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Pre-Natal:

  1. BMI greater than or equal to 25
  2. 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?)
  3. English-speaking
* Post-partum:

  1. Live birth (based on medical record review)

Exclusion Criteria:

* Pre-Natal:

  1. Signs of moderate to severe depression based on the Patient Health Questionnaire-9 (PHQ-9)
  2. Previous enrollment in the Birth Sister's program prior to the study
* Post-partum:

  1. Signs of moderate to severe post-partum depression based on the Edinburgh Postnatal Depression Scale (EPDS)

Primary outcomes:
measure: Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
timeFrame: Weekly up to 8 weeks
Secondary outcomes:
measure: Change From Baseline Weight to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Participant Satisfaction as Measured by Questionnaire and Exit Interview
timeFrame: 8 weeks
measure: Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire
timeFrame: Baseline and 8 weeks
measure: Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire
timeFrame: Baseline and 8 weeks
measure: Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale
timeFrame: Baseline and 8 weeks
measure: Waist Circumference at 8 Weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Medicine and Pediatrics
name: Caroline M. Apovian, MD
role: PRINCIPAL_INVESTIGATOR
References: