Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes
Star-Mama
Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program
1 other identifier
interventional
181
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2014
CompletedFirst Posted
Study publicly available on registry
September 15, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2018
CompletedFebruary 11, 2021
February 1, 2021
3.3 years
September 11, 2014
February 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Behavior change
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 Outcomes (1)
Weight loss
6-12 months post-partum
Study Arms (2)
Life Style counseling (Star-Mama)
ACTIVE COMPARATORStar-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.
Educational Resource Support
NO INTERVENTIONParticipants 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Postpartum Latino women (English or Spanish speakers) with history of gestational diabetes.
- years or older
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- San Francisco Department of Public Healthcollaborator
- San Francisco General Hospitalcollaborator
- Sonoma Department of Public Healthcollaborator
Study Sites (1)
San Francisco General Hospital
San Francisco, California, 94110, United States
Related Publications (3)
Horwitz MEM, Edwards CV, Athavale P, McCloskey L, Cabral HJ, Benjamin EJ, Handley MA. The STAR-MAMA RCT: Bilingual Mobile Health Coaching for Postpartum Weight Loss. Am J Prev Med. 2023 Oct;65(4):596-607. doi: 10.1016/j.amepre.2023.03.021. Epub 2023 Apr 5.
PMID: 37028566DERIVEDAthavale P, Thomas M, Delgadillo-Duenas AT, Leong K, Najmabadi A, Harleman E, Rios C, Quan J, Soria C, Handley MA. Linking High Risk Postpartum Women with a Technology Enabled Health Coaching Program to Reduce Diabetes Risk and Improve Wellbeing: Program Description, Case Studies, and Recommendations for Community Health Coaching Programs. J Diabetes Res. 2016;2016:4353956. doi: 10.1155/2016/4353956. Epub 2016 Oct 26.
PMID: 27830157DERIVEDHandley MA, Harleman E, Gonzalez-Mendez E, Stotland NE, Althavale P, Fisher L, Martinez D, Ko J, Sausjord I, Rios C. Applying the COM-B model to creation of an IT-enabled health coaching and resource linkage program for low-income Latina moms with recent gestational diabetes: the STAR MAMA program. Implement Sci. 2016 May 18;11(1):73. doi: 10.1186/s13012-016-0426-2.
PMID: 27193580DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret A. Handley, MPH, PhD
University of California, San Francisco
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
September 11, 2014
First Posted
September 15, 2014
Study Start
December 1, 2014
Primary Completion
March 10, 2018
Study Completion
September 28, 2018
Last Updated
February 11, 2021
Record last verified: 2021-02