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

Primary Purpose

Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life Style Counseling (Star-Mama)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring Type 2 diabetes prevention in the post-partum, Behavior change among Latinas,, Health Coaching, Motivational interviewing techniques

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Life Style counseling (Star-Mama)

Educational Resource Support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weight loss
Women in the intervention arm will have weight losses related to improved behaviors on physical activity, healthier nutrition habits and breastfeeding.

Full Information

First Posted
September 11, 2014
Last Updated
February 10, 2021
Sponsor
University of California, San Francisco
Collaborators
San Francisco Department of Public Health, San Francisco General Hospital, Sonoma Department of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT02240420
Brief Title
Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes
Acronym
Star-Mama
Official Title
Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
March 10, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Department of Public Health, San Francisco General Hospital, Sonoma Department of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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); Women in the STAR-Moms program will have improved diabetes prevention knowledge; 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes prevention in the post-partum, Behavior change among Latinas,, Health Coaching, Motivational interviewing techniques

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Hybrid type 1 effectiveness implementation design, focusing on weight loss and behavior change outcomes, as well as engagement and acceptability of the intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Life Style counseling (Star-Mama)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Educational Resource Support
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Life Style Counseling (Star-Mama)
Other Intervention Name(s)
Star-Mama intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Behavior change
Description
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.
Time Frame
6 month -12 months post-partum
Secondary Outcome Measure Information:
Title
Weight loss
Description
Women in the intervention arm will have weight losses related to improved behaviors on physical activity, healthier nutrition habits and breastfeeding.
Time Frame
6-12 months post-partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret A. Handley, MPH, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27830157
Citation
Athavale 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.
Results Reference
derived
PubMed Identifier
27193580
Citation
Handley 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.
Results Reference
derived

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Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes

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