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Reducing Obesity in Underserved Postpartum African American Women (RENEW)

Boston Medical Center (BMC) logo

Boston Medical Center (BMC)

Status

Completed

Conditions

Obesity

Treatments

Behavioral: Nutrition and physical activity education

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02448563
R21HD061311 (U.S. NIH Grant/Contract)
H-28272
U54TR001012 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 2 patient groups

Intervention
Experimental group
Description:
Weekly, in-person, support groups providing nutrition and physical activity education
Treatment:
Behavioral: Nutrition and physical activity education
Control
No Intervention group
Description:
Standard of care - one counseling visit with a study dietitian

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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