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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preventing Postpartum Weight Retention Among Low-Income, Black Women

Conditions
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Pregnancy, Weight Loss, Behavioral, Obesity

Intervention / Treatment
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* Behavioral: Healthy Lifestyle Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Lifestyle Group<br>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<br>* 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<br>|
| No Intervention: Usual Care<br>This condition is meant to represent standard clinical care provided to pregnant and postpartum mothers at Temple University. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum |  | Approximately 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Postpartum, Weight Retention, Behavioral, Electronically-mediated