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

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

Tracking Information

• First Submitted Date: January 23, 2012
• First Posted Date: February 10, 2012
• Last Update Posted Date: May 21, 2018
• Study Start Date: January 2012
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Healthy4Baby: Preventing Postpartum Weight Retention Among Low-Income, Black Women
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Pregnancy
• Weight Loss
• Behavioral
• Obesity

Intervention

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

• 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 *

• Herring SJ, Cruice JF, Bennett GG, Rose MZ, Davey A, Foster GD. Preventing excessive gestational weight gain among African American women: A randomized clinical trial. Obesity (Silver Spring). 2016 Jan;24(1):30-6. doi: 10.1002/oby.21240. Epub 2015 Nov 23.
• Herring SJ, Cruice JF, Bennett GG, Darden N, Wallen JJ, Rose MZ, Davey A, Foster GD. Intervening during and after pregnancy to prevent weight retention among African American women. Prev Med Rep. 2017 Jun 1;7:119-123. doi: 10.1016/j.pmedr.2017.05.015. eCollection 2017 Sep.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2016): 66
• Original Estimated Enrollment (submitted: February 9, 2012): 98
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01530776
• Other Study ID Numbers: 20227; K23HL106231 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Temple University
• Study Sponsor: Temple University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Sharon J. Herring, MD, MPH; Temple University

• PRS Account: Temple University
• Verification Date: May 2018