Obesity
Conditions
Keywords
Pregnancy, African American, Weight Management Program, Behavioral Modifications
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.
Interventions
Eight weekly in-person groups
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) | Weekly up to 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 8 weeks | 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). |
| Change From Baseline Weight to 8 Weeks | Baseline and 8 weeks | — |
| Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale | Baseline and 8 weeks | 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 | 8 weeks | — |
| Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Baseline and 8 weeks | 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Completers Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups | 16 |
| Intervention Non-completers Non-completers
Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups | 16 |
| Control Completers Standard of care - one counseling visit with a study dietitian | 19 |
| Control Non-completers Non-completers
Standard of care - one counseling visit with a study dietitian | 11 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 10 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Control Completers | Intervention Completers | Intervention Non-completers | Control Non-completers |
|---|---|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 6.2 | 30.5 years STANDARD_DEVIATION 6.6 | 29.5 years STANDARD_DEVIATION 5.1 | 30.3 years STANDARD_DEVIATION 7.4 | 32.6 years STANDARD_DEVIATION 5.3 |
| Body mass index (BMI) | 35.0 kg/m^2 STANDARD_DEVIATION 6.5 | 34.8 kg/m^2 STANDARD_DEVIATION 6.1 | 35.2 kg/m^2 STANDARD_DEVIATION 8.8 | 35.6 kg/m^2 STANDARD_DEVIATION 6.4 | 34.1 kg/m^2 STANDARD_DEVIATION 3.6 |
| Breastfeeding No | 21 participants | 6 participants | 4 participants | 4 participants | 7 participants |
| Breastfeeding Yes | 41 participants | 13 participants | 12 participants | 12 participants | 4 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 62 Participants | 19 Participants | 16 Participants | 16 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 62 Participants | 19 Participants | 16 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Waist circumference | 108.6 centimeters STANDARD_DEVIATION 14.6 | 109.6 centimeters STANDARD_DEVIATION 14.8 | 107.3 centimeters STANDARD_DEVIATION 18.3 | 108.1 centimeters STANDARD_DEVIATION 13.8 | 109.5 centimeters STANDARD_DEVIATION 8.3 |
| Weight | 94.3 kilograms STANDARD_DEVIATION 18.9 | 92.3 kilograms STANDARD_DEVIATION 17.9 | 91.4 kilograms STANDARD_DEVIATION 22.8 | 100.5 kilograms STANDARD_DEVIATION 19.8 | 93.2 kilograms STANDARD_DEVIATION 12.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 0 / 32 | 0 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 30 |
Outcome results
Primary
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Time frame: Weekly up to 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) | Attended 75% of sessions or more | 9 participants |
| Intervention | Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) | Attended at least 1 session, but <75% of sessions | 12 participants |
| Intervention | Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) | Attended no sessions | 11 participants |
Secondary
Change From Baseline Weight to 8 Weeks
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change From Baseline Weight to 8 Weeks | 2.4 kilograms | Standard Error 0.4 |
| Control | Change From Baseline Weight to 8 Weeks | 2.2 kilograms | Standard Error 0.3 |
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.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Appearance orientation | -0.02 units on a scale | Standard Error 0.1 |
| Intervention | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Overweight preoccupation | 0.3 units on a scale | Standard Error 0.2 |
| Intervention | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Body areas satisfaction | 0.1 units on a scale | Standard Error 0.1 |
| Intervention | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Self-classified weight | -0.1 units on a scale | Standard Error 0.1 |
| Intervention | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Appearance evaluation | 0.1 units on a scale | Standard Error 0.2 |
| Control | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Self-classified weight | -0.2 units on a scale | Standard Error 0.1 |
| Control | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Appearance evaluation | 0.2 units on a scale | Standard Error 0.1 |
| Control | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Appearance orientation | -0.02 units on a scale | Standard Error 0.1 |
| Control | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Body areas satisfaction | 0.1 units on a scale | Standard Error 0.1 |
| Control | Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire | Overweight preoccupation | 0.1 units on a scale | Standard Error 0.1 |
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).
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Low fat eating | 4.7 z-score | Standard Error 2.4 |
| Intervention | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Emotional eating | 1.5 z-score | Standard Error 2 |
| Intervention | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Snacking | -0.8 z-score | Standard Error 1.3 |
| Intervention | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Cultural/lifestyle behaviors | 0.6 z-score | Standard Error 1 |
| Intervention | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Haphazard planning | -2.3 z-score | Standard Error 1.7 |
| Intervention | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Meal skipping | -1.3 z-score | Standard Error 0.9 |
| Control | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Haphazard planning | -4.6 z-score | Standard Error 1.1 |
| Control | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Low fat eating | 4.2 z-score | Standard Error 1.8 |
| Control | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Cultural/lifestyle behaviors | -0.6 z-score | Standard Error 0.8 |
| Control | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Emotional eating | -1.2 z-score | Standard Error 1.2 |
| Control | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Meal skipping | -1.6 z-score | Standard Error 0.7 |
| Control | Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire | Snacking | -2.8 z-score | Standard Error 0.8 |
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).
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale | Household/Caregiving Index | -0.1 units on a scale | Standard Error 0.1 |
| Intervention | Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale | Active Living Index | 0.4 units on a scale | Standard Error 0.2 |
| Intervention | Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale | Sports and Exercise Index | -0.6 units on a scale | Standard Error 0.4 |
| Control | Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale | Household/Caregiving Index | 0.2 units on a scale | Standard Error 0.1 |
| Control | Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale | Active Living Index | 0.1 units on a scale | Standard Error 0.2 |
| Control | Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale | Sports and Exercise Index | -0.3 units on a scale | Standard Error 0.3 |
Secondary
Participant Satisfaction as Measured by Questionnaire and Exit Interview
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Enjoyed Program | 100 Percentage |
| Intervention | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Program met diet/exercise needs | 60 Percentage |
| Intervention | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Program met other health concerns | 73 Percentage |
| Intervention | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Interventionist was responsive to questions | 100 Percentage |
| Intervention | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Interventionist was helpful/available | 53 Percentage |
| Intervention | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Program should be continued at hospital | 93 Percentage |
| Control | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Interventionist was helpful/available | 26 Percentage |
| Control | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Enjoyed Program | 58 Percentage |
| Control | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Interventionist was responsive to questions | 74 Percentage |
| Control | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Program met diet/exercise needs | 26 Percentage |
| Control | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Program should be continued at hospital | 58 Percentage |
| Control | Participant Satisfaction as Measured by Questionnaire and Exit Interview | Program met other health concerns | 32 Percentage |
Secondary
Waist Circumference at 8 Weeks
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Waist Circumference at 8 Weeks | 107.3 centimeters | Standard Deviation 18.3 |
| Control | Waist Circumference at 8 Weeks | 108.1 centimeters | Standard Deviation 13.8 |
| Control Completers | Waist Circumference at 8 Weeks | 109.6 centimeters | Standard Deviation 14.8 |
| Control Non-completers | Waist Circumference at 8 Weeks | 109.5 centimeters | Standard Deviation 8.3 |