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Completed

NCT Number: NCT02229708

Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

The purpose of this study is to find out whether a technology-base healthy lifestyle program is an acceptable and effective way for African-American mothers to improve their eating and activity during pregnancy, compared to usual obstetric care. The goal of the program is to enhance the health of African-American mothers and their babies.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Temple University

Philadelphia, Pennsylvania, 19140, United States

About this study

Black women are in particular need for obesity prevention and treatment. The childbearing period represents a critical life stage of heightened vulnerability for new or persistent obesity, especially among Black women, who retain 2-3 times more weight after pregnancy than White women. Pregnancy weight gain is the strongest identified risk factor for retaining a substantial amount of weight after pregnancy, yet few published interventions have been effective in reducing excessive weight gain in pregnancy, particularly among low-income Black mothers.

The proposed research aims to meets the needs of low-income, Black mothers by developing a novel pregnancy intervention that 1) focuses solely on Black women, 2) incorporates Black mothers' information needs, values, and social context, and 3) uses technology to facilitate participant engagement.

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

  • 1. 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 participation in the study
  • 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

Primary outcomes

  1. Change in maternal weight from early pregnancy to 6 months and 1 year postpartum

    Time frame: Approximately 18 months

Secondary outcomes

  1. Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum

    Time frame: Approximately 18 months

  2. 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

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity: a Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Sep 1, 2014
Registry last updated
Oct 17, 2019

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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