Reducing Obesity in Underserved Postpartum African American Women (RENEW)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrition and physical activity education
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Pregnancy, African American, Weight Management Program, Behavioral Modifications
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Weekly, in-person, support groups providing nutrition and physical activity education
Standard of care - one counseling visit with a study dietitian
Outcomes
Primary Outcome Measures
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Secondary Outcome Measures
Change From Baseline Weight to 8 Weeks
Participant Satisfaction as Measured by Questionnaire and Exit Interview
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire
Items were rated on a 5 point scale (1 strongly disagree, 2 disagree, 3 neutral or not applicable, 4 agree, 5 strongly agree). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score).
Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire
The Multidimensional Body Relations Questionnaire (MBSRQ-AS) includes the following subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale (BASS). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score). Scale ranges from 1-5 (1=definitely disagree, 2=mostly disagree, 3=neither agree nor disagree, 4=mostly agree, 5=definitely agree) with higher scores reflecting better outcome. A positive value shows improvement in that subscale over time.
Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale
Activity indices were created for each domain of activity (household/caregiving, occupational, active living, sports/exercise) by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at Baseline from that measured at 8 weeks (difference = 8 weeks score - baseline score).
Waist Circumference at 8 Weeks
Full Information
NCT ID
NCT02448563
First Posted
May 12, 2015
Last Updated
June 27, 2017
Sponsor
Boston Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02448563
Brief Title
Reducing Obesity in Underserved Postpartum African American Women
Acronym
RENEW
Official Title
Reducing Obesity in Underserved Postpartum African American Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Pregnancy, African American, Weight Management Program, Behavioral Modifications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Weekly, in-person, support groups providing nutrition and physical activity education
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care - one counseling visit with a study dietitian
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and physical activity education
Intervention Description
Eight weekly in-person groups
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change From Baseline Weight to 8 Weeks
Time Frame
Baseline and 8 weeks
Title
Participant Satisfaction as Measured by Questionnaire and Exit Interview
Time Frame
8 weeks
Title
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire
Description
Items were rated on a 5 point scale (1 strongly disagree, 2 disagree, 3 neutral or not applicable, 4 agree, 5 strongly agree). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score).
Time Frame
Baseline and 8 weeks
Title
Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire
Description
The Multidimensional Body Relations Questionnaire (MBSRQ-AS) includes the following subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale (BASS). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score). Scale ranges from 1-5 (1=definitely disagree, 2=mostly disagree, 3=neither agree nor disagree, 4=mostly agree, 5=definitely agree) with higher scores reflecting better outcome. A positive value shows improvement in that subscale over time.
Time Frame
Baseline and 8 weeks
Title
Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale
Description
Activity indices were created for each domain of activity (household/caregiving, occupational, active living, sports/exercise) by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at Baseline from that measured at 8 weeks (difference = 8 weeks score - baseline score).
Time Frame
Baseline and 8 weeks
Title
Waist Circumference at 8 Weeks
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline M. Apovian, MD
Organizational Affiliation
Professor of Medicine and Pediatrics
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Reducing Obesity in Underserved Postpartum African American Women
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