Clinical trial NCT01530776: Healthy4Baby: Preventing Postpartum Weight Retention Among Low-Income, Black Women
Official title: Preventing Postpartum Weight Retention Among Low-Income, Black Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy
Weight Loss
Behavioral
Obesity
Keywords: Pregnancy
Postpartum
Weight Retention
Behavioral
Electronically-mediated
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-02-10
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum
timeFrame: Approximately 18 months
Secondary outcomes:
measure: Change in maternal weight from early pregnancy to delivery
timeFrame: Approximately 6 months
measure: 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
timeFrame: Approximately 18 months
measure: Change in infant weight and length from birth to 6 months and 1 year of age
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Sharon J. Herring, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.