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Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

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ClinicalTrials.gov Identifier: NCT02229708
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pregnancy Body Weight Changes Behavioral Obesity Behavioral: Healthy Lifestyle Group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : July 16, 2017
Actual Study Completion Date : July 17, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in maternal weight from early pregnancy to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in infant weight and length from birth to 6 months and 1 year of age [ Time Frame: Approximately 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229708


Locations
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United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
HRSA/Maternal and Child Health Bureau
Investigators
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Principal Investigator: Sharon J Herring, MD, MPH Temple University

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02229708     History of Changes
Other Study ID Numbers: 22201
R40MC26818 ( Other Grant/Funding Number: US Department of Health and Human Services, HRSA )
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Keywords provided by Temple University:
Pregnancy
Weight control
Behavioral
technology-based intervention
Additional relevant MeSH terms:
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Obesity
Body Weight
Weight Gain
Body Weight Changes
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms