Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

NCT ID: NCT02229708

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-07-17

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.

Conditions

Pregnancy; Body Weight Changes; Behavioral; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Lifestlye Group

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.

Group Type: EXPERIMENTAL

Healthy Lifestyle Group

Intervention Type: BEHAVIORAL

Interventions

Healthy Lifestyle Group

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

HRSA/Maternal and Child Health Bureau

FED

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon J Herring, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R40MC26818

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22201

Identifier Type: -

Identifier Source: org_study_id