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

Primary Purpose

Pregnancy, Weight Loss, Behavioral

Status

Completed

Phase

Phase 2

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, Postpartum, Weight Retention, Behavioral, Electronically-mediated

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:

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 study participation
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

Experimental

No Intervention

Arm Label

Healthy Lifestyle Group

Usual Care

Arm Description

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.

This condition is meant to represent standard clinical care provided to pregnant and postpartum mothers at Temple University.

Outcomes

Primary Outcome Measures

Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum

Secondary Outcome Measures

Change in maternal weight from early pregnancy to delivery

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

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

Full Information

NCT ID

NCT01530776

First Posted

January 23, 2012

Last Updated

May 17, 2018

Sponsor

Temple University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01530776

Brief Title

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

Official Title

Preventing Postpartum Weight Retention Among Low-Income, Black Women

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Pregnancy, Weight Loss, Behavioral, Obesity

Keywords

Pregnancy, Postpartum, Weight Retention, Behavioral, Electronically-mediated

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Lifestyle Group

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

This condition is meant to represent standard clinical care provided to pregnant and postpartum mothers at Temple University.

Intervention Type

Behavioral

Intervention Name(s)

Healthy Lifestyle Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum

Time Frame

Approximately 18 months

Secondary Outcome Measure Information:

Title

Change in maternal weight from early pregnancy to delivery

Time Frame

Approximately 6 months

Title

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: 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 study participation 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

Citations:

PubMed Identifier

26592857

Citation

Herring SJ, Cruice JF, Bennett GG, Rose MZ, Davey A, Foster GD. Preventing excessive gestational weight gain among African American women: A randomized clinical trial. Obesity (Silver Spring). 2016 Jan;24(1):30-6. doi: 10.1002/oby.21240. Epub 2015 Nov 23.

Results Reference

result

PubMed Identifier

28660118

Citation

Herring SJ, Cruice JF, Bennett GG, Darden N, Wallen JJ, Rose MZ, Davey A, Foster GD. Intervening during and after pregnancy to prevent weight retention among African American women. Prev Med Rep. 2017 Jun 1;7:119-123. doi: 10.1016/j.pmedr.2017.05.015. eCollection 2017 Sep.

Results Reference

result

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

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