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Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

Primary Purpose

Pregnancy, Body Weight Changes, Behavioral

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Healthy Lifestyle Group

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Pregnancy, Weight control, Behavioral, technology-based intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Healthy Lifestlye Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in maternal weight from early pregnancy to 6 months and 1 year postpartum

Secondary Outcome Measures

Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum

Change in infant weight and length from birth to 6 months and 1 year of age

Full Information

NCT ID

NCT02229708

First Posted

August 28, 2014

Last Updated

October 15, 2019

Sponsor

Temple University

Collaborators

HRSA/Maternal and Child Health Bureau

1. Study Identification

Unique Protocol Identification Number

NCT02229708

Brief Title

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

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

July 16, 2017 (Actual)

Study Completion Date

July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

Collaborators

HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy, Body Weight Changes, Behavioral, Obesity

Keywords

Pregnancy, Weight control, Behavioral, technology-based intervention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Arm Title

Healthy Lifestlye Group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Healthy Lifestyle Group

Primary Outcome Measure Information:

Title

Change in maternal weight from early pregnancy to 6 months and 1 year postpartum

Time Frame

Approximately 18 months

Secondary Outcome Measure Information:

Title

Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum

Time Frame

Approximately 18 months

Title

Change in infant weight and length from birth to 6 months and 1 year of age

Time Frame

Approximately 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon J Herring, MD, MPH

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Temple University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

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