Reducing Obesity in Underserved Postpartum African American Women

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

Boston Medical Center

Washirika

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

JARIBIO LA KLINIKI: NCT02448563

BioSeek: nct02448563

Maneno muhimu

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho:	05/31/2017
Iliyowasilishwa Kwanza:	05/11/2015
Uandikishaji uliokadiriwa Uliwasilishwa:	05/14/2015
Iliyotumwa Kwanza:	05/18/2015
Sasisho la Mwisho Liliwasilishwa:	06/26/2017
Sasisho la Mwisho Lilichapishwa:	08/08/2017
Tarehe ya matokeo ya kwanza yaliyowasilishwa:	07/24/2016
Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa:	06/26/2017
Tarehe ya matokeo ya kwanza kuchapishwa:	08/08/2017
Tarehe halisi ya kuanza kwa masomo:	07/31/2011
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	08/31/2013
Tarehe ya Kukamilisha Utafiti:	08/31/2013

Hali au ugonjwa

Obesity

Uingiliaji / matibabu

Behavioral: Intervention

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: Intervention Weekly, in-person, support groups providing nutrition and physical activity education	Behavioral: Intervention Eight weekly in-person groups
No Intervention: Control Standard of care - one counseling visit with a study dietitian

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	18 Years Kwa 18 Years
Jinsia Inastahiki Kujifunza	Female
Hupokea Wajitolea wa Afya	Ndio
Vigezo	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)

Matokeo

Hatua za Matokeo ya Msingi

1. Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) [Weekly up to 8 weeks]

Hatua za Matokeo ya Sekondari

1. Change From Baseline Weight to 8 Weeks [Baseline and 8 weeks]

2. Participant Satisfaction as Measured by Questionnaire and Exit Interview [8 weeks]

3. 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).

4. 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.

5. 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).

6. Waist Circumference at 8 Weeks [8 weeks]