Trial Outcomes & Findings for Reducing Obesity in Underserved Postpartum African American Women (NCT NCT02448563)

NCT ID: NCT02448563

Last Updated: 2017-08-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 128 participants
• Primary outcome timeframe: Weekly up to 8 weeks
• Results posted on: 2017-08-09

Participant Flow

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.

Participant milestones

Measure	Intervention Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control Standard of care - one counseling visit with a study dietitian
Overall Study STARTED	32	30
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	16	11

Reasons for withdrawal

Measure	Intervention Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control Standard of care - one counseling visit with a study dietitian
Overall Study Lost to Follow-up	16	10
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Reducing Obesity in Underserved Postpartum African American Women

Baseline characteristics by cohort

Measure	Intervention Completers n=16 Participants Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Intervention Non-completers n=16 Participants Non-completers Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control Completers n=19 Participants Standard of care - one counseling visit with a study dietitian	Control Non-completers n=11 Participants Non-completers Standard of care - one counseling visit with a study dietitian	Total n=62 Participants Total of all reporting groups
Age, Continuous	29.5 years STANDARD_DEVIATION 5.1 • n=5 Participants	30.3 years STANDARD_DEVIATION 7.4 • n=7 Participants	30.5 years STANDARD_DEVIATION 6.6 • n=5 Participants	32.6 years STANDARD_DEVIATION 5.3 • n=4 Participants	30.6 years STANDARD_DEVIATION 6.2 • n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants	11 Participants n=4 Participants	62 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants	11 Participants n=4 Participants	62 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Weight	91.4 kilograms STANDARD_DEVIATION 22.8 • n=5 Participants	100.5 kilograms STANDARD_DEVIATION 19.8 • n=7 Participants	92.3 kilograms STANDARD_DEVIATION 17.9 • n=5 Participants	93.2 kilograms STANDARD_DEVIATION 12.1 • n=4 Participants	94.3 kilograms STANDARD_DEVIATION 18.9 • n=21 Participants
Body mass index (BMI)	35.2 kg/m^2 STANDARD_DEVIATION 8.8 • n=5 Participants	35.6 kg/m^2 STANDARD_DEVIATION 6.4 • n=7 Participants	34.8 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants	34.1 kg/m^2 STANDARD_DEVIATION 3.6 • n=4 Participants	35.0 kg/m^2 STANDARD_DEVIATION 6.5 • n=21 Participants
Waist circumference	107.3 centimeters STANDARD_DEVIATION 18.3 • n=5 Participants	108.1 centimeters STANDARD_DEVIATION 13.8 • n=7 Participants	109.6 centimeters STANDARD_DEVIATION 14.8 • n=5 Participants	109.5 centimeters STANDARD_DEVIATION 8.3 • n=4 Participants	108.6 centimeters STANDARD_DEVIATION 14.6 • n=21 Participants
Breastfeeding Yes	12 participants n=5 Participants	12 participants n=7 Participants	13 participants n=5 Participants	4 participants n=4 Participants	41 participants n=21 Participants
Breastfeeding No	4 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	7 participants n=4 Participants	21 participants n=21 Participants

PRIMARY outcome

Timeframe: Weekly up to 8 weeks

Outcome measures

Measure	Intervention n=32 Participants Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control Standard of care - one counseling visit with a study dietitian	Control Completers Standard of care - one counseling visit with a study dietitian	Control Non-completers Non-completers Standard of care - one counseling visit with a study dietitian
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	—	—	—
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	—	—	—
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) Attended no sessions	11 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Intervention n=16 Participants Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control n=19 Participants Standard of care - one counseling visit with a study dietitian	Control Completers Standard of care - one counseling visit with a study dietitian	Control Non-completers Non-completers Standard of care - one counseling visit with a study dietitian
Change From Baseline Weight to 8 Weeks	2.4 kilograms Standard Error 0.4	2.2 kilograms Standard Error 0.3	—	—

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	Intervention n=16 Participants Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control n=19 Participants Standard of care - one counseling visit with a study dietitian	Control Completers Standard of care - one counseling visit with a study dietitian	Control Non-completers Non-completers Standard of care - one counseling visit with a study dietitian
Participant Satisfaction as Measured by Questionnaire and Exit Interview Program met diet/exercise needs	60 Percentage	26 Percentage	—	—
Participant Satisfaction as Measured by Questionnaire and Exit Interview Program met other health concerns	73 Percentage	32 Percentage	—	—
Participant Satisfaction as Measured by Questionnaire and Exit Interview Interventionist was responsive to questions	100 Percentage	74 Percentage	—	—
Participant Satisfaction as Measured by Questionnaire and Exit Interview Enjoyed Program	100 Percentage	58 Percentage	—	—
Participant Satisfaction as Measured by Questionnaire and Exit Interview Interventionist was helpful/available	53 Percentage	26 Percentage	—	—
Participant Satisfaction as Measured by Questionnaire and Exit Interview Program should be continued at hospital	93 Percentage	58 Percentage	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Intervention n=16 Participants Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control n=19 Participants Standard of care - one counseling visit with a study dietitian	Control Completers Standard of care - one counseling visit with a study dietitian	Control Non-completers Non-completers Standard of care - one counseling visit with a study dietitian
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire Snacking	-0.8 z-score Standard Error 1.3	-2.8 z-score Standard Error 0.8	—	—
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	4.2 z-score Standard Error 1.8	—	—
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire Emotional eating	1.5 z-score Standard Error 2.0	-1.2 z-score Standard Error 1.2	—	—
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire Cultural/lifestyle behaviors	0.6 z-score Standard Error 1.0	-0.6 z-score Standard Error 0.8	—	—
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	-4.6 z-score Standard Error 1.1	—	—
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	-1.6 z-score Standard Error 0.7	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=16 Participants Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control n=19 Participants Standard of care - one counseling visit with a study dietitian	Control Completers Standard of care - one counseling visit with a study dietitian	Control Non-completers Non-completers Standard of care - one counseling visit with a study dietitian
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	-0.2 units on a scale Standard Error 0.1	—	—
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	0.2 units on a scale Standard Error 0.1	—	—
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	-0.02 units on a scale Standard Error 0.1	—	—
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	0.1 units on a scale Standard Error 0.1	—	—
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	0.1 units on a scale Standard Error 0.1	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Intervention n=16 Participants Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control n=19 Participants Standard of care - one counseling visit with a study dietitian	Control Completers Standard of care - one counseling visit with a study dietitian	Control Non-completers Non-completers Standard of care - one counseling visit with a study dietitian
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	0.2 units on a scale Standard Error 0.1	—	—
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	0.1 units on a scale Standard Error 0.2	—	—
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	-0.3 units on a scale Standard Error 0.3	—	—

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	Intervention n=16 Participants Weekly, in-person, support groups providing nutrition and physical activity education Nutrition and physical activity education: Eight weekly in-person groups	Control n=16 Participants Standard of care - one counseling visit with a study dietitian	Control Completers n=19 Participants Standard of care - one counseling visit with a study dietitian	Control Non-completers n=11 Participants Non-completers Standard of care - one counseling visit with a study dietitian
Waist Circumference at 8 Weeks	107.3 centimeters Standard Deviation 18.3	108.1 centimeters Standard Deviation 13.8	109.6 centimeters Standard Deviation 14.8	109.5 centimeters Standard Deviation 8.3

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ashley McCarthy, Clinical Research Manager

Boston Medical Center

Phone: 617-638-5906

Email: ashley.mccarthy@bmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place