Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

Not Applicable

Completed

• Conditions: Body Weight Changes; Behavioral; Pregnancy; Obesity
• Interventions: Behavioral: Healthy Lifestyle Group

• Registration Number: NCT02229708
• Lead Sponsor: Temple University

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.

Study Timeline

• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-08-28
• Study Start: 2014-09
• Study First Posted: 2014-09-01
• Primary Completion: 2017-07-16
• Study Completion: 2019-07-17
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Lifestlye Group	Healthy Lifestyle 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.

Primary Outcome Measures

Name	Time	Method
Change in maternal weight from early pregnancy to 6 months and 1 year postpartum	Approximately 18 months

Secondary Outcome Measures

Name	Time	Method
Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum	Approximately 18 months
Change in infant weight and length from birth to 6 months and 1 year of age	Approximately 12 months

Trial Locations

Locations (1)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States