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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD061311 | U.S. NIH Grant/Contract | View source | |
| U54TR001012 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Weekly, in-person, support groups providing nutrition and physical activity education |
|
| Control | No Intervention | Standard of care - one counseling visit with a study dietitian |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition and physical activity education | Behavioral | Eight weekly in-person groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) | Weekly up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Weight to 8 Weeks | Baseline and 8 weeks | |
| Participant Satisfaction as Measured by Questionnaire and Exit Interview | 8 weeks | |
| Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire |
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Inclusion Criteria:
Pre-Natal:
Post-partum:
Exclusion Criteria:
Pre-Natal:
Post-partum:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline M. Apovian, MD | Professor of Medicine and Pediatrics | Principal Investigator |
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Participants were considered "enrolled" when they signed the informed consent form. From the time of enrollment to intervention start, 66 participants either withdrew from the study or became lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups |
| FG001 | Control | Standard of care - one counseling visit with a study dietitian |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Completers | Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups |
| BG001 | Intervention Non-completers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) | Posted | Number | participants | Weekly up to 8 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashley McCarthy, Clinical Research Manager | Boston Medical Center | 617-638-5906 | ashley.mccarthy@bmc.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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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). |
| 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. | 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). | Baseline and 8 weeks |
| Waist Circumference at 8 Weeks | 8 weeks |
Non-completers
Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups
| BG002 | Control Completers | Standard of care - one counseling visit with a study dietitian |
| BG003 | Control Non-completers | Non-completers Standard of care - one counseling visit with a study dietitian |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference | Mean | Standard Deviation | centimeters |
|
| Breastfeeding | Number | participants |
|
|
| Secondary | Change From Baseline Weight to 8 Weeks | Posted | Mean | Standard Error | kilograms | Baseline and 8 weeks |
|
|
|
| Secondary | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Posted | Number | Percentage | 8 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Error | z-score | Baseline and 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Waist Circumference at 8 Weeks | Posted | Mean | Standard Deviation | centimeters | 8 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Control | Standard of care - one counseling visit with a study dietitian | 0 | 30 | 0 | 30 | 0 | 30 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003710 | Demography |
| D011154 | Population Characteristics |
| Program met other health concerns |
|
| Interventionist was responsive to questions |
|
| Interventionist was helpful/available |
|
| Program should be continued at hospital |
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| Snacking |
|
| Cultural/lifestyle behaviors |
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| Haphazard planning |
|
| Meal skipping |
|
| Body areas satisfaction |
|
| Overweight preoccupation |
|
| Self-classified weight |
|
| Sports and Exercise Index |
|