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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Temple University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01530776
First received: January 23, 2012
Last updated: January 17, 2014
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Pregnancy
Weight Loss
Behavioral
Obesity
Behavioral: Healthy Lifestyle Group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Postpartum Weight Retention Among Low-Income, Black Women

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in infant weight and length from birth to 6 months and 1 year of age [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Usual Care
This condition is meant to represent standard clinical care provided to pregnant and postpartum mothers at Temple University.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530776

Contacts
Contact: Sharon J. Herring, MD, MPH 215-707-2234 Sharon.Herring@temple.edu
Contact: Jane Cruice, RN 215-707-8651 tue92027@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: Jane Cruice, RN    215-707-8651    tue92027@temple.edu   
Principal Investigator: Sharon J. Herring, MD, MPH         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Sharon J. Herring, MD, MPH Temple University
  More Information

No publications provided

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01530776     History of Changes
Other Study ID Numbers: 20227, K23HL106231
Study First Received: January 23, 2012
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Temple University:
Pregnancy
Postpartum
Weight Retention
Behavioral
Electronically-mediated

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

ClinicalTrials.gov processed this record on August 21, 2014