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Healthy4Baby: Preventing Postpartum Weight Retention Among Low-Income, Black Women

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ClinicalTrials.gov Identifier: NCT01530776
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date  ICMJE January 23, 2012
First Posted Date  ICMJE February 10, 2012
Last Update Posted Date May 21, 2018
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
  • Change in maternal weight from early pregnancy to delivery [ Time Frame: Approximately 6 months ]
  • Change in maternal cardiometabolic biomarkers and additional anthropometrics (insulin sensitivity and secretion, fasting lipids, blood pressure, waist circumference) from early pregnancy to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ]
  • Change in infant weight and length from birth to 6 months and 1 year of age [ Time Frame: Approximately 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
  • Change in maternal cardiometabolic biomarkers and additional anthropometrics (insulin sensitivity and secretion, fasting lipids, blood pressure, waist circumference) from early pregnancy to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ]
  • Change in infant weight and length from birth to 6 months and 1 year of age [ Time Frame: Approximately 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy4Baby: Preventing Postpartum Weight Retention Among Low-Income, Black Women
Official Title  ICMJE Preventing Postpartum Weight Retention Among Low-Income, Black Women
Brief Summary The purpose of this study is to assess the feasibility and efficacy of an electronically-mediated, pregnancy and postpartum, behavioral intervention program, compared to usual obstetric care, on changes in weight and cardiometabolic biomarkers among overweight and obese Black women.
Detailed Description Black women are in particular need for obesity prevention and treatment. Targeting the childbearing period has the potential to slow the accumulation of weight gain among this high risk group. Previous interventions to prevent postpartum weight retention among Blacks are sparse and limited by poor intervention adherence, high attrition, and failure to include pregnancy in the study design. The proposed research aims to overcome these shortcomings by developing an intervention that 1) focuses solely on Black women, 2) incorporates Black mothers' information needs, values, and social context, 3) uses technology to facilitate participant engagement, and 4) includes both the pregnancy and postpartum periods.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pregnancy
  • Weight Loss
  • Behavioral
  • Obesity
Intervention  ICMJE Behavioral: Healthy Lifestyle Group
Electronically-mediated, behavioral intervention during and after pregnancy encouraging mothers to eat healthy, exercise, and return to their early pregnancy weights by 1 year postpartum
Study Arms  ICMJE
  • Experimental: Healthy Lifestyle Group
    Participants randomized to this condition will receive information and strategies to help them eat healthier and be more active during and after pregnancy. They will get this information about eating and activity through handouts, text messages, Facebook updates, and in-person visits and phone calls from a health coach.
    Intervention: Behavioral: Healthy Lifestyle Group
  • No Intervention: Usual Care
    This condition is meant to represent standard clinical care provided to pregnant and postpartum mothers at Temple University.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2016)
66
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2012)
98
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pregnant African-American women at least 18 years of age
  2. BMI at recruitment between 25.0-44.9 kg/m2
  3. Singleton pregnancy
  4. Gestational age of ≤ 20 weeks as determined by last menstrual period
  5. Plan to carry the pregnancy to term and keep the baby
  6. Own a cell phone with a text messaging plan
  7. Member of Facebook social networking site
  8. Able to participate in physical activity
  9. Participants must be willing to comply with all study-related procedures

Exclusion Criteria:

  1. BMI ≤ 24.9 or ≥ 45.0
  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. Uncontrolled thyroid disease. Participants with controlled thyroid disease on medication for at least three months are allowable.
  7. Known cancer
  8. Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
  9. History of testing HIV positive
  10. Current smoker or tobacco user
  11. Current or recent history (past 6 months) of drug or alcohol abuse or dependence
  12. Participation in any weight control or investigational drug study within 6 weeks of screening
  13. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful study participation
  14. Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
  15. Previous weight loss surgery
  16. History of bulimia or anorexia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530776
Other Study ID Numbers  ICMJE 20227
K23HL106231 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Sharon J. Herring, MD, MPH Temple University
PRS Account Temple University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP