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Community-based Obesity Treatment in African American Women After Childbirth

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ClinicalTrials.gov Identifier: NCT02829229
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Temple University

Brief Summary:
The purpose of this study is to determine the effect of the community-based obesity treatment (PP), compared to usual care (UC), on changes in maternal weight over 12 months.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Community-based obesity treatment (PP) Not Applicable

Detailed Description:
The investigators propose to randomize overweight or obese, African American postpartum WIC participants (n=300) to either usual care (UC) or a community-based obesity treatment (PP) arm. Recruitment will occur in 6 of Philadelphia Women Infants Children's (WIC) clinic sites in the early postpartum period (≤ 6 months after birth). Once enrolled, participants will complete surveys and baseline assessments of their weight, waist circumference, blood pressure, and height at The Center for Obesity Research and Education (CORE). Participants will also have a fasting blood sample taken. Study staff will administer a number of questionnaires assessing demographics, psychosocial factors, contextual factors, and behavioral targets via questionnaires prior to randomization. Participants will then be randomized to the 12-month postpartum weight loss intervention (PP) or usual care (UC). Additional assessments will be conducted at 6 and 12 months post baseline. The PP arm includes expanded obesogenic behavior change goals, tailored skills training materials, interactive self-monitoring text messages, video testimonials, and interpersonal counseling support through health coach calls and Facebook. Data will be analyzed using an intent-to-treat (ITT) approach where subjects are analyzed according to their treatment assignment at randomization, regardless of level of engagement. The primary outcome is weight loss at 12 months. If successful, the expected results could provide a sustainable, low-cost, postpartum weight loss intervention model for widespread dissemination to reduce disparities in obesity and cardiometabolic comorbidities.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Community-based Obesity Treatment in African American Women After Childbirth: a Randomized Controlled Trial of Women Infant Children (WIC) Mothers
Actual Study Start Date : September 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual care (UC)
Usual postpartum WIC care
Experimental: Community-based obesity treatment (PP)
The PP arm includes expanded obesogenic behavior change goals, tailored skills training materials, interactive self-monitoring text messages, video testimonials, and interpersonal counseling support through health coach calls and Facebook.
Behavioral: Community-based obesity treatment (PP)
Participants in the treatment (PP) arm will receive a 5-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; 4)Video testimonials & 5)Interpersonal counseling. Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.




Primary Outcome Measures :
  1. Weight loss (kilograms) [ Time Frame: At baseline and 12 months ]
    Weight will be measured using a calibrated scale at baseline and 12-month follow-up. Weight loss will be calculated as the difference between mean 12-month and baseline weight in kilograms.


Secondary Outcome Measures :
  1. Obesogenic dietary behaviors [ Time Frame: At baseline and 12 months ]
    Using National Cancer Institute's Diet History Questionnaire, the investigators will assess categories of sugary drink intake, fast/fried food intake, and snacking at baseline and 12-month follow-up.

  2. Insulin Resistance [ Time Frame: At baseline and 12 months ]
    Blood will be drawn to assess insulin resistance (insulin and glucose). The Homeostatic model assessment for Insulin Resistance (HOMA-IR) calculation will be used to quantify participant mean insulin resistance at baseline and 12-month follow-up.

  3. Health-related quality of life [ Time Frame: At baseline and 12 months ]
    Short Form-12 (SF-12) questionnaire will be used to collect health-related quality of life at baseline and 12-month follow-up.

  4. Physical Activity [ Time Frame: At baseline and 12 months ]
    Wrist Actigraphy will be used to measure physical activity (average number of steps) at baseline and 12-month follow-up.

  5. Physical Activity [ Time Frame: At baseline and 12 months ]
    Wrist Actigraphy will be used to measure physical activity (average intensity of activity) at baseline and 12-month follow-up.

  6. Sleep [ Time Frame: At baseline and 12 months ]
    Wrist Actigraphy will be used to measure sleep (mean duration of sleep) at baseline and 12-month follow-up.

  7. Sleep [ Time Frame: At baseline and 12 months ]
    Wrist Actigraphy will be used to measure sleep (mean sleep efficiency) at baseline and 12-month follow-up.

  8. Sleep [ Time Frame: At baseline and 12 months ]
    Wrist Actigraphy will be used to measure sleep (mean wake after sleep onset) at baseline and 12-month follow-up.

  9. Hemoglobin A1c (HbA1c) [ Time Frame: At baseline and 12 months ]
    Hemoglobin A1c test will be performed by a lab to identify the 3-month average plasma glucose concentration at baseline and 12-month follow-up. The investigators will categorize participants as no diabetes (HbA1c <5.7), prediabetes (HBA1c 5.7-6.4), and diabetes (HBA1c >6.4) at both timepoints.

  10. Lipids [ Time Frame: At baseline and 12 months ]
    Total cholesterol test will be performed by a lab to identify mean total blood cholesterol level, low density lipoprotein and high density lipoprotein levels at baseline and 12-month follow-up.


Other Outcome Measures:
  1. Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential [ Time Frame: 12 months ]
    The five steps are Reach the target population; Effectiveness; Adoption by target staff, settings or institutions; Implementation consistency, costs and adaptions made during delivery and Maintenance of intervention effects in individuals and settings over time. Previously collected data such as target population characteristics; attrition and completion percentages; results related to primary, secondary and unintended outcomes; intervention fidelity; participant knowledge application and sustainability will be used within scope of 5 steps to determine dissemination potential.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Self-identification as African American
  2. Self-report pre-pregnancy BMI between 25-49.9 kg/m2
  3. Measured BMI at baseline between 25-49.9 kg/m2
  4. Philadelphia WIC participant
  5. Singleton birth
  6. Between 1 and 6 months postpartum
  7. Own a cell phone with an unlimited text messaging plan
  8. Able to participate in light physical activity (walking)
  9. Participants must be willing to comply with all study-related procedures
  10. Participants must be able to read and write fluently in English

Exclusion Criteria:

  1. BMI ≤ 24.9 or ≥ 50.0 kg/m2
  2. Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure > 95 mmHg). Participants with controlled hypertension on medication for at least three months are allowable.
  3. Known atherosclerotic cardiovascular disease
  4. Known congestive heart failure
  5. Known diabetes mellitus (type 1 or type 2)
  6. Known thyroid disease
  7. Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
  8. History of testing HIV positive
  9. Current smoker or tobacco user. Participants with < 5 cigarettes daily are allowable
  10. Current or recent history (past 6 months) of drug or alcohol abuse or dependence
  11. Participation in any weight control or investigational drug study within 6 weeks of screening
  12. Current consumption of any of the following medications: appetite suppressants, anti-psychotics, lipase inhibitors
  13. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful participation in the study
  14. Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
  15. Previous weight loss surgery
  16. History of bulimia or anorexia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829229


Contacts
Contact: Sharon J. Herring, MD, MPH 2157072234 Sharon.Herring@temple.edu
Contact: Veronica Bersani, MPH 2157078664 tuf59011@temple.edu

Locations
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Sharon J Herring, MD, MPH    215-707-2234    Sharon.Herring@temple.edu   
Contact: Veronica Bersani, MPH    215-707-8664    tuf59011@temple.edu   
Principal Investigator: Sharon J. Herring, MD, MPH         
Sponsors and Collaborators
Temple University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Sharon J Herring, MD MPH Temple University

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02829229     History of Changes
Other Study ID Numbers: 23187
R01HL130816 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Dr. Herring (PI) will ensure that all publications that result from data collected as part of this project will comply with the NIH public access policy. Also, Dr. Herring agrees to develop a transportable de-identified database, codebook, and mechanism by which data can be shared with other investigators upon approval of the study's research team. The Resource Sharing Plan will be reviewed and approved by Temple University's Institutional Review Board.

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms