Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02240420
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2014-09-11
Brief Title:
Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Star-Mama
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
Women in the STAR-MAMA will have lost more weight than women in the control group
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None