Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss, Obesity Weight Loss, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:9/19/2018
Start Date:September 2014
End Date:July 17, 2019

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

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.

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.

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
We found this trial at
1
site
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Sharon J Herring, MD, MPH
Phone: 215-707-2234
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