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

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT01530776

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Weight Loss Behavioral Obesity	Behavioral: Healthy Lifestyle Group	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Preventing Postpartum Weight Retention Among Low-Income, Black Women

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum [Approximately 18 months]

Secondary Outcome Measures

Change in maternal weight from early pregnancy to delivery [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 [Approximately 18 months]
Change in infant weight and length from birth to 6 months and 1 year of age [Approximately 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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