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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy Weight Loss Behavioral Obesity Behavioral: Healthy Lifestyle Group Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Postpartum Weight Retention Among Low-Income, Black Women
Study Start Date : January 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ]

Secondary Outcome Measures :
  1. Change in maternal weight from early pregnancy to delivery [ Time Frame: Approximately 6 months ]
  2. 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 ]
  3. Change in infant weight and length from birth to 6 months and 1 year of age [ Time Frame: Approximately 12 months ]

Eligibility Criteria
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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. 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
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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): NCT01530776


Locations
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United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Sharon J. Herring, MD, MPH Temple University
More Information
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Publications of Results:

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01530776    
Other Study ID Numbers: 20227
K23HL106231 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Keywords provided by Temple University:
Pregnancy
Postpartum
Weight Retention
Behavioral
Electronically-mediated
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Gestational Weight Gain
Body Weight Changes
Weight Gain