Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

Temple University

Status: Completed

Conditions: Behavioral; Obesity; Body Weight Changes; Pregnancy

Treatments: Behavioral: Healthy Lifestyle Group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02229708

R40MC26818 (Other Grant/Funding Number)

22201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 262 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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262 participants in 2 patient groups

Usual Care

No Intervention group

Description:

The Usual Obstetric Care group will receive usual advice about nutrition and activity during pregnancy from their obstetrician along with some additional information about pregnancy and childbirth through readings from The American College of Obstetricians and Gynecologists. In addition, participants will receive weekly text messages to maintain contact and ensure follow-up.

Healthy Lifestlye Group

Experimental group

Description:

The Healthy Lifestyle Group will take part in an individual, technology-based behavioral intervention program which will include specific information about nutrition and physical activity, and strategies for helping them make changes to their diet, physical activity, and weight-related behaviors during pregnancy. Participants will receive information through print materials, text messages, a private Facebook group, and in-person visits and phone calls from a health coach who is part of our research team.

Treatment:

Behavioral: Healthy Lifestyle Group