Healthy4Baby: Preventing Postpartum Weight Retention Among Low-Income, Black Women

May 17, 2018 updated by: Temple University

Preventing Postpartum Weight Retention Among Low-Income, Black Women

The purpose of this study is to assess the feasibility and efficacy of an electronically-mediated, pregnancy and postpartum, behavioral intervention program, compared to usual obstetric care, on changes in weight and cardiometabolic biomarkers among overweight and obese Black women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Black women are in particular need for obesity prevention and treatment. Targeting the childbearing period has the potential to slow the accumulation of weight gain among this high risk group. Previous interventions to prevent postpartum weight retention among Blacks are sparse and limited by poor intervention adherence, high attrition, and failure to include pregnancy in the study design. The proposed research aims to overcome these shortcomings by developing an intervention that 1) focuses solely on Black women, 2) incorporates Black mothers' information needs, values, and social context, 3) uses technology to facilitate participant engagement, and 4) includes both the pregnancy and postpartum periods.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Pregnant African-American women at least 18 years of age
  2. BMI at recruitment between 25.0-44.9 kg/m2
  3. Singleton pregnancy
  4. Gestational age of ≤ 20 weeks as determined by last menstrual period
  5. Plan to carry the pregnancy to term and keep the baby
  6. Own a cell phone with a text messaging plan
  7. Member of Facebook social networking site
  8. Able to participate in physical activity
  9. Participants must be willing to comply with all study-related procedures

Exclusion Criteria:

  1. BMI ≤ 24.9 or ≥ 45.0
  2. 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.
  3. Known atherosclerotic cardiovascular disease
  4. Known congestive heart failure
  5. Known diabetes mellitus (type 1 or type 2)
  6. Uncontrolled thyroid disease. Participants with controlled thyroid disease on medication for at least three months are allowable.
  7. Known cancer
  8. Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
  9. History of testing HIV positive
  10. Current smoker or tobacco user
  11. Current or recent history (past 6 months) of drug or alcohol abuse or dependence
  12. Participation in any weight control or investigational drug study within 6 weeks of screening
  13. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful study participation
  14. Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
  15. Previous weight loss surgery
  16. History of bulimia or anorexia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Lifestyle Group
Participants randomized to this condition will receive information and strategies to help them eat healthier and be more active during and after pregnancy. They will get this information about eating and activity through handouts, text messages, Facebook updates, and in-person visits and phone calls from a health coach.
Behavioral: Healthy Lifestyle Group
Electronically-mediated, behavioral intervention during and after pregnancy encouraging mothers to eat healthy, exercise, and return to their early pregnancy weights by 1 year postpartum
No Intervention: Usual Care
This condition is meant to represent standard clinical care provided to pregnant and postpartum mothers at Temple University.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum
Time Frame: Approximately 18 months
Approximately 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in infant weight and length from birth to 6 months and 1 year of age
Time Frame: Approximately 12 months
Approximately 12 months
Change in maternal weight from early pregnancy to delivery
Time Frame: Approximately 6 months
Approximately 6 months
Change in maternal cardiometabolic biomarkers and additional anthropometrics (insulin sensitivity and secretion, fasting lipids, blood pressure, waist circumference) from early pregnancy to 6 months and 1 year postpartum
Time Frame: Approximately 18 months
Approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Sharon J. Herring, MD, MPH, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20227
  • K23HL106231 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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