Reducing Obesity in Underserved Postpartum African American Women

NCT ID: NCT02448563

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-09-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Weekly, in-person, support groups providing nutrition and physical activity education

Group Type: EXPERIMENTAL

Nutrition and physical activity education

Intervention Type: BEHAVIORAL

Eight weekly in-person groups

Control

Standard of care - one counseling visit with a study dietitian

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutrition and physical activity education

Eight weekly in-person groups

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Caroline Apovian

Professor of Medicine and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline M. Apovian, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine and Pediatrics

Other Identifiers

R21HD061311

Identifier Type: NIH

Identifier Source: secondary_id

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U54TR001012

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-28272

Identifier Type: -

Identifier Source: org_study_id