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Completed

NCT Number: NCT01530776

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Temple University

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • BMI ≤ 24.9 or ≥ 45.0
  • 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.
  • Known atherosclerotic cardiovascular disease
  • Known congestive heart failure
  • Known diabetes mellitus (type 1 or type 2)
  • Uncontrolled thyroid disease. Participants with controlled thyroid disease on medication for at least three months are allowable.
  • Known cancer
  • Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
  • History of testing HIV positive
  • Current smoker or tobacco user
  • Current or recent history (past 6 months) of drug or alcohol abuse or dependence
  • Participation in any weight control or investigational drug study within 6 weeks of screening
  • Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful study participation
  • Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
  • Previous weight loss surgery
  • History of bulimia or anorexia

Treatment and study plan

Healthy Lifestyle Group

Behavioral

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

Primary outcomes

  1. Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum

    Time frame: Approximately 18 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Preventing Postpartum Weight Retention Among Low-Income, Black Women

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2012
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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