Clinical trial NCT02229708: Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity
Official title: Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Body Weight Changes
Behavioral
Obesity
Keywords: Pregnancy
Weight control
Behavioral
technology-based intervention
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2014-09-01
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in maternal weight from early pregnancy to 6 months and 1 year postpartum
timeFrame: Approximately 18 months
Secondary outcomes:
measure: Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum
timeFrame: Approximately 18 months
measure: Change in infant weight and length from birth to 6 months and 1 year of age
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Sharon J Herring, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: