Healthy4Baby: Preventing Postpartum Weight Retention Among Low-Income, Black Women
This study is ongoing, but not recruiting participants.
Sponsor:
Temple University
Collaborator:
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01530776
First received: January 23, 2012
Last updated: February 9, 2012
Last verified: January 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pregnancy Weight Loss Behavioral Obesity |
Behavioral: Healthy Lifestyle Group |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Preventing Postpartum Weight Retention Among Low-Income, Black Women |
Resource links provided by NLM:
Further study details as provided by Temple University:
Primary Outcome Measures:
- Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: Approximately 18 months ] [ Designated as safety issue: No ]
- Change in infant weight and length from birth to 6 months and 1 year of age [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 98 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530776
Locations
| United States, Pennsylvania | |
| Temple University | |
| Philadelphia, Pennsylvania, United States, 19140 | |
Sponsors and Collaborators
Temple University
Investigators
| Principal Investigator: | Sharon J. Herring, MD, MPH | Temple University |
More Information
No publications provided
| Responsible Party: | Temple University |
| ClinicalTrials.gov Identifier: | NCT01530776 History of Changes |
| Other Study ID Numbers: | 20227, K23HL106231 |
| Study First Received: | January 23, 2012 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Temple University:
|
Pregnancy Postpartum Weight Retention Behavioral Electronically-mediated |
Additional relevant MeSH terms:
|
Obesity Urinary Retention Weight Loss Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Urination Disorders Urologic Diseases Body Weight Changes |
ClinicalTrials.gov processed this record on June 18, 2013