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

Type 2 Diabetes Mellitus Clinical Trial

— Star-Mama  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240420
• Other study ID #: CFDA 10.586
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: September 28, 2018

Study information

• Verified date: February 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: September 28, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Department of Public Health, San Francisco General Hospital, Sonoma Department of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight loss	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