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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Gestational Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Behavioral: Life Style Counseling (Star-Mama)

Study type: Interventional

Funder types: Other

Identifiers

NCT02240420

CFDA 10.586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

Life Style counseling (Star-Mama)

Active Comparator group

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.

Treatment:

Behavioral: Life Style Counseling (Star-Mama)

Educational Resource Support

No Intervention group

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.