Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes (Star-Mama)

February 10, 2021 updated by: University of California, San Francisco

Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program

The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base counseling intervention for young Latino women who are at high risk of diabetes. The intervention will focus at the end of pregnancy and the 9 months post-partum period to improve education and behavioral counseling on nutrition and other related health topics .

The following hypotheses will be formally tested:

Compared with controls at 9 months post-partum:

  1. Women in the STAR-Moms program will have improved self-reported behavioral outcomes for minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);
  2. Women in the STAR-Moms program will have improved diabetes prevention knowledge;
  3. Women in the STAR-Moms program will have increased diabetes-relevant screening rates.

Women in the STAR-MAMA will have lost more weight than women in the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The STAR-MAMA intervention builds on theoretical constructs found in Social Cognitive Theory, Theory of Planned Behavior, and Theories of Social Support found to be effective in weight loss, physical activity and dietary change, based on a recent meta-analysis and other studies. The investigators proposed development of STAR-MAMA will incorporate specific behavior change techniques associated with these theories, including: "self-regulatory" intervention techniques (specific goal setting, prompting self-monitoring, providing feedback on performance, goal review), self-efficacy building intervention techniques (motivational interviewing, using decisional balance and relapse prevention), individual tailoring techniques (information on content and resources), and culturally tailored social support, and which incorporates family needs.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postpartum Latino women (English or Spanish speakers) with history of gestational diabetes.
  • 18 years or older

Exclusion Criteria:

  • Do not have type 1 or type 2 diabetes.
  • Do not have access to phone line or a cellphone to receive weekly calls of health coaching education over the phone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Life Style counseling (Star-Mama)
Star-Mama intervention group will receive during 6 months weekly phone calls with queries and narratives about health habits. The participant's answers will be sent to a health coach who will follow up with the participant, and develop a plan with the participant to address her needs.
Behavioral: Life Style Counseling (Star-Mama)
Participants enrolled in the Star-Mama intervention group will receive 1. weekly automated phone calls with prevention-focused queries (e.g., diet, exercise, breastfeeding). 2. If a participant generates a value rated "out of range," a health coach who receives daily electronic downloads of STAR-Mama responses will call the participant to coach her about the specific health issue. Participants also hear recorded narratives related to their "out of range" reply encouraging behavior change. 3. Call-backs enable coaches to engage patients in goals setting/action plans and providing information about community resources
Other Names:
  • Star-Mama intervention
No Intervention: Educational Resource Support
Participants in the control group of the study will receive a set of educational materials with information about their health and the health of their babies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavior change
Time Frame: 6 month -12 months post-partum
Women in the intervention arm of the study (Star-Mama) will have behavior changes that lower their risk of developing gestational diabetes in the next pregnancy of type 2 diabetes later in life.
6 month -12 months post-partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 6-12 months post-partum
Women in the intervention arm will have weight losses related to improved behaviors on physical activity, healthier nutrition habits and breastfeeding.
6-12 months post-partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

San Francisco Department of Public Health
San Francisco General Hospital
Sonoma Department of Public Health

Investigators

  • Principal Investigator: Margaret A. Handley, MPH, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

March 10, 2018

Study Completion (Actual)

September 28, 2018

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFDA 10.586

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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