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

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus; Type 2 Diabetes Mellitus
• Interventions: Behavioral: Life Style Counseling (Star-Mama)

• Registration Number: NCT02240420
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-15
• Study Start: 2014-12
• Primary Completion: 2018-03-10
• Study Completion: 2018-09-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 181

Inclusion Criteria

• Postpartum Latino women (English or Spanish speakers) with history of gestational diabetes.
• 18 years or older

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Life Style counseling (Star-Mama)	Life Style Counseling (Star-Mama)	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.

Primary Outcome Measures

Name	Time	Method
Behavior change	6 month -12 months post-partum	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

Name	Time	Method
Weight loss	6-12 months post-partum	Women in the intervention arm will have weight losses related to improved behaviors on physical activity, healthier nutrition habits and breastfeeding.

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States