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PregnancyPhase 2NCT01530776

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

A Phase 2 study testing Healthy Lifestyle Group in people with Pregnancy and Weight Loss, run by Temple University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Weight Loss, Behavioral
What is being tested?
Healthy Lifestyle Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Jan 2012to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • Member of Facebook social networking site
  • Able to participate in physical activity
  • Participants must be willing to comply with all study-related procedures

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Temple University

    Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Healthy Lifestyle Group
Keywords
Pregnancy, Postpartum, Weight Retention, Behavioral, Electronically-mediated
Medical subject headings
Weight Loss, Behavior, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Lifestyle GroupBehavioural

    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

Study groups in NCT01530776
Study groupRoleWhat they receive
Healthy Lifestyle GroupExperimentalParticipants 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.
Receives: Behavioral: Healthy Lifestyle Group
Usual CareNo interventionThis condition is meant to represent standard clinical care provided to pregnant and postpartum mothers at Temple University.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Approximately 18 months

Secondary outcomes (3)

  1. Change in maternal weight from early pregnancy to delivery

    Measured: Approximately 6 months

  2. 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

    Measured: Approximately 18 months

  3. Change in infant weight and length from birth to 6 months and 1 year of age

    Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01530776
Sponsor's protocol ID
20227
Other IDs
K23HL106231
Status last verified
May 2018
First submitted
23 Jan 2012
Last updated
21 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Herring SJ, Cruice JF, Bennett GG, Rose MZ, Davey A, Foster GD. Preventing excessive gestational weight gain among African American women: A randomized clinical trial. Obesity (Silver Spring). 2016 Jan;24(1):30-6. doi: 10.1002/oby.21240. Epub 2015 Nov 23.

    PubMed 26592857

  • Herring SJ, Cruice JF, Bennett GG, Darden N, Wallen JJ, Rose MZ, Davey A, Foster GD. Intervening during and after pregnancy to prevent weight retention among African American women. Prev Med Rep. 2017 Jun 1;7:119-123. doi: 10.1016/j.pmedr.2017.05.015. eCollection 2017 Sep.

    PubMed 28660118

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Healthy Lifestyle Group in people with Pregnancy and Weight Loss, run by Temple University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum (time frame: Approximately 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01530776, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.

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