Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity

Obesity Clinical Trial

Official title:

Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229708
• Other study ID #: 22201
• Secondary ID: R40MC26818
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 17, 2019

Study information

• Verified date: October 2019
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out whether a technology-base healthy lifestyle program is an acceptable and effective way for African-American mothers to improve their eating and activity during pregnancy, compared to usual obstetric care. The goal of the program is to enhance the health of African-American mothers and their babies.

Description:

Black women are in particular need for obesity prevention and treatment. The childbearing period represents a critical life stage of heightened vulnerability for new or persistent obesity, especially among Black women, who retain 2-3 times more weight after pregnancy than White women. Pregnancy weight gain is the strongest identified risk factor for retaining a substantial amount of weight after pregnancy, yet few published interventions have been effective in reducing excessive weight gain in pregnancy, particularly among low-income Black mothers.

The proposed research aims to meets the needs of low-income, Black mothers by developing a novel pregnancy intervention that 1) focuses solely on Black women, 2) incorporates Black mothers' information needs, values, and social context, and 3) uses technology to facilitate participant engagement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: July 17, 2019
• Est. primary completion date: July 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

• 1. 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 participation in the study

• Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)

• Previous weight loss surgery

• History of bulimia or anorexia

Related Conditions & MeSH terms

• Behavioral
• Body Weight
• Body Weight Changes
• Obesity
• Pregnancy
• Weight Gain

Intervention

Behavioral:
• Healthy Lifestyle Group

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maternal weight from early pregnancy to 6 months and 1 year postpartum		Approximately 18 months
Secondary	Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum		Approximately 18 months
Secondary	Change in infant weight and length from birth to 6 months and 1 year of age		Approximately 12 months