Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT02229708

Collaborator

HRSA/Maternal and Child Health Bureau (U.S. Fed)

262

Enrollment

Location

Arms

58.5

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Body Weight Changes Behavioral Obesity	Behavioral: Healthy Lifestyle Group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

262 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jul 16, 2017

Actual Study Completion Date :

Jul 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: Healthy Lifestyle Group

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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.

Behavioral: Healthy Lifestyle Group

Outcome Measures

Primary Outcome Measures

Change in maternal weight from early pregnancy to 6 months and 1 year postpartum [Approximately 18 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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