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

Obesity Clinical Trial

Official title:

Preventing Postpartum Weight Retention Among Low-Income, Black Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530776
• Other study ID #: 20227
• Secondary ID: K23HL106231
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: March 2016

Study information

• Verified date: May 2018
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavioral
• Body Weight
• Obesity
• Pregnancy
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. eCo — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum		Approximately 18 months
Secondary	Change in maternal weight from early pregnancy to delivery		Approximately 6 months
Secondary	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		Approximately 18 months
Secondary	Change in infant weight and length from birth to 6 months and 1 year of age		Approximately 12 months