NCT02240420

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gestational Diabetes Mellitus
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-03-10
• Completion: 2018-09-28
• First posted: 2014-09-15
• Last updated: 2021-02-11

Locations

1 site across 1 country: United States