Clinical trial NCT02240420: Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes
Official title: Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Department of Public Health
name: San Francisco General Hospital
name: Sonoma Department of Public Health
First posted: 2014-09-15
Enrollment: 181
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Behavior change
timeFrame: 6 month -12 months post-partum
Secondary outcomes:
measure: Weight loss
timeFrame: 6-12 months post-partum
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Margaret A. Handley, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Athavale P, Thomas M, Delgadillo-Duenas AT, Leong K, Najmabadi A, Harleman E, Rios C, Quan J, Soria C, Handley MA. Linking High Risk Postpartum Women with a Technology Enabled Health Coaching Program to Reduce Diabetes Risk and Improve Wellbeing: Program Description, Case Studies, and Recommendations for Community Health Coaching Programs. J Diabetes Res. 2016;2016:4353956. doi: 10.1155/2016/4353956. Epub 2016 Oct 26.
citation: Handley MA, Harleman E, Gonzalez-Mendez E, Stotland NE, Althavale P, Fisher L, Martinez D, Ko J, Sausjord I, Rios C. Applying the COM-B model to creation of an IT-enabled health coaching and resource linkage program for low-income Latina moms with recent gestational diabetes: the STAR MAMA program. Implement Sci. 2016 May 18;11(1):73. doi: 10.1186/s13012-016-0426-2.