Gestational Diabetes MellitusStar-MamaNCT02240420
Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes
A study testing Life Style Counseling (Star-Mama) in people with Gestational Diabetes Mellitus and Type 2 Diabetes Mellitus, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- Life Style Counseling (Star-Mama)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 28 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum Latino women (English or Spanish speakers) with history of gestational diabetes.
- 18 years or older
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program
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:
Read more
Compared with controls at 9 months post-partum:
- 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);
- Women in the STAR-Moms program will have improved diabetes prevention knowledge;
- 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.
Read the 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.
- Being tested
- Life Style Counseling (Star-Mama)
- Keywords
- Type 2 diabetes prevention in the post-partum, Behavior change among Latinas,, Health Coaching, Motivational interviewing techniques
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Style Counseling (Star-Mama)Behavioural
Also called Star-Mama intervention
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
| Study group | Role | What they receive |
|---|---|---|
| Life Style counseling (Star-Mama) | Active comparator | 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. Receives: Behavioral: Life Style Counseling (Star-Mama) |
| Educational Resource Support | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior change
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.
Measured: 6 month -12 months post-partum
Secondary outcomes (1)
Weight loss
Women in the intervention arm will have weight losses related to improved behaviors on physical activity, healthier nutrition habits and breastfeeding.
Measured: 6-12 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startDec 2014
- Primary completion10 Mar 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Department of Public Health, San Francisco General Hospital, Sonoma Department of Public Health
- Responsible party
- Sponsor
- Investigators
- Margaret A. Handley, MPH, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240420
- Sponsor's protocol ID
- CFDA 10.586
- Acronym
- Star-Mama
- Status last verified
- Feb 2021
- First submitted
- 11 Sep 2014
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Horwitz MEM, Edwards CV, Athavale P, McCloskey L, Cabral HJ, Benjamin EJ, Handley MA. The STAR-MAMA RCT: Bilingual Mobile Health Coaching for Postpartum Weight Loss. Am J Prev Med. 2023 Oct;65(4):596-607. doi: 10.1016/j.amepre.2023.03.021. Epub 2023 Apr 5.
PubMed 37028566Athavale 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.
PubMed 27830157Handley 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.
PubMed 27193580
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program
- ClinicalTrials.gov ID
- NCT02240420
- Acronym / sponsor ID
- Star-Mama / CFDA 10.586
- Keywords
- Type 2 diabetes prevention in the post-partum, Behavior change among Latinas,, Health Coaching, Motivational interviewing techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Department of Public Health, San Francisco General Hospital, Sonoma Department of Public Health
- Study start
- Dec 2014 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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);
- Women in the STAR-Moms program will have improved diabetes prevention knowledge;
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Life Style counseling (Star-Mama) | Active comparator | Behavioral: 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. |
| Educational Resource Support | No intervention | –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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Postpartum Latino women (English or Spanish speakers) with history of gestational diabetes.
- 18 years or older
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Style Counseling (Star-Mama)Also: Star-Mama interventionParticipants 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 | Behavioural | Life Style counseling (Star-Mama) |
Primary outcome
Behavior change
Time frame: 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.
1 secondary outcome
Weight loss
Time frame: 6-12 months post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 37028566Horwitz MEM, Edwards CV, Athavale P, McCloskey L, Cabral HJ, Benjamin EJ, Handley MA. The STAR-MAMA RCT: Bilingual Mobile Health Coaching for Postpartum Weight Loss. Am J Prev Med. 2023 Oct;65(4):596-607. doi: 10.1016/j.amepre.2023.03.021. Epub 2023 Apr 5.
- Derived from this study: PubMed 27830157Athavale 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.
- Derived from this study: PubMed 27193580Handley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret A. Handley, MPH, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Style Counseling (Star-Mama) in people with Gestational Diabetes Mellitus and Type 2 Diabetes Mellitus, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior change (time frame: 6 month -12 months post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.