ObesityRENEWNCT02448563
Reducing Obesity in Underserved Postpartum African American Women
A study testing Nutrition and physical activity education in people with Obesity, run by Boston Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrition and physical activity education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
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.
Read the 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
- Being tested
- Nutrition and physical activity education
- Keywords
- Pregnancy, African American, Weight Management Program, Behavioral Modifications
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and physical activity educationBehavioural
Eight weekly in-person groups
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Weekly, in-person, support groups providing nutrition and physical activity education Receives: Behavioral: Nutrition and physical activity education |
| Control | No intervention | Standard of care - one counseling visit with a study dietitian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Measured: Weekly up to 8 weeks
Secondary outcomes (6)
Change From Baseline Weight to 8 Weeks
Measured: Baseline and 8 weeks
Participant Satisfaction as Measured by Questionnaire and Exit Interview
Measured: 8 weeks
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).
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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).
Measured: Baseline and 8 weeks
Waist Circumference at 8 Weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Caroline Apovian, Boston Medical Center
- Investigators
- Caroline M. Apovian, MD, Principal investigator, Professor of Medicine and Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448563
- Sponsor's protocol ID
- H-28272
- Other IDs
- R21HD061311, U54TR001012
- Acronym
- RENEW
- Status last verified
- Jun 2017
- First submitted
- 12 May 2015
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Obesity in Underserved Postpartum African American Women
- ClinicalTrials.gov ID
- NCT02448563
- Acronym / sponsor ID
- RENEW / H-28272
- Conditions
- Obesity
- Keywords
- Pregnancy, African American, Weight Management Program, Behavioral Modifications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Posted 9 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nutrition and physical activity educationWeekly, in-person, support groups providing nutrition and physical activity education |
| Control | No intervention | –Standard of care - one counseling visit with a study dietitian |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pre-Natal:
- Post-partum:
Key exclusion criteria (5 listed)
- Pre-Natal:
- Post-partum:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and physical activity educationEight weekly in-person groups | Behavioural | Intervention |
Primary outcome
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Time frame: Weekly up to 8 weeks
6 secondary outcomes
Change From Baseline Weight to 8 Weeks
Time frame: Baseline and 8 weeks
Participant Satisfaction as Measured by Questionnaire and Exit Interview
Time frame: 8 weeks
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire
Time frame: Baseline and 8 weeks
Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire
Time frame: Baseline and 8 weeks
Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale
Time frame: Baseline and 8 weeks
Waist Circumference at 8 Weeks
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline M. Apovian, MD principal investigator
Professor of Medicine and Pediatrics
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and physical activity education in people with Obesity, run by Boston Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) (time frame: Weekly up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.