NCT02229708

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

2.9 years

First QC Date

August 28, 2014

Last Update Submit

October 15, 2019

Conditions

PregnancyBody Weight ChangesBehavioralObesity

Keywords

PregnancyWeight controlBehavioraltechnology-based intervention

Outcome Measures

Primary Outcomes (1)

  • Change in maternal weight from early pregnancy to 6 months and 1 year postpartum

    Approximately 18 months

Secondary Outcomes (2)

  • Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) 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

Study Arms (2)

Usual Care

NO INTERVENTION

The Usual Obstetric Care group will receive usual advice about nutrition and activity during pregnancy from their obstetrician along with some additional information about pregnancy and childbirth through readings from The American College of Obstetricians and Gynecologists. In addition, participants will receive weekly text messages to maintain contact and ensure follow-up.

Healthy Lifestlye Group

EXPERIMENTAL

The Healthy Lifestyle Group will take part in an individual, technology-based behavioral intervention program which will include specific information about nutrition and physical activity, and strategies for helping them make changes to their diet, physical activity, and weight-related behaviors during pregnancy. Participants will receive information through print materials, text messages, a private Facebook group, and in-person visits and phone calls from a health coach who is part of our research team.

Behavioral: Healthy Lifestyle Group

Interventions

Healthy Lifestyle GroupBEHAVIORAL
Healthy Lifestlye Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Body Weight ChangesBehaviorObesity

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Sharon J Herring, MD, MPH

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 1, 2014

Study Start

September 1, 2014

Primary Completion

July 16, 2017

Study Completion

July 17, 2019

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

US(1)