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

Temple University

Status and phase: Completed; Phase 2

Conditions: Weight Loss; Behavioral; Obesity; Pregnancy

Treatments: Behavioral: Healthy Lifestyle Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01530776

K23HL106231 (U.S. NIH Grant/Contract)

20227

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 2 patient groups

Healthy Lifestyle Group

Experimental group

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.

Treatment:

Behavioral: Healthy Lifestyle Group

Usual Care

No Intervention group

Description:

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