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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02240420
Acronym
Star-Mama
Enrollment
181
Registered
2014-09-15
Start date
2014-12-31
Completion date
2018-09-28
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes prevention in the post-partum, Behavior change among Latinas,, Health Coaching, Motivational interviewing techniques

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.

Interventions

BEHAVIORALLife 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

Sponsors

San Francisco Department of Public Health
CollaboratorOTHER_GOV
San Francisco General Hospital
CollaboratorOTHER
Sonoma Department of Public Health
CollaboratorUNKNOWN
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Hybrid type 1 effectiveness implementation design, focusing on weight loss and behavior change outcomes, as well as engagement and acceptability of the intervention

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Behavior change6 month -12 months post-partumWomen 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

MeasureTime frameDescription
Weight loss6-12 months post-partumWomen in the intervention arm will have weight losses related to improved behaviors on physical activity, healthier nutrition habits and breastfeeding.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026