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| ID | Type | Description | Link |
|---|---|---|---|
| K01DK099404 | U.S. NIH Grant/Contract | View source | |
| P30DK092924 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study examines whether a health message that includes a self-affirmation intervention (where people reflect on values that are important to them) increases acceptance of the message and encourages people to take steps to prevent diabetes, as compared to a health message without the self affirmation intervention.
Background: Despite availability of evidence-based programs for diabetes prevention, few strategies exist to promote patients' interest in them. Strategies should be developed for racial/ethnic minority women with a history of gestational diabetes (GDM), who face exceptionally high risk for chronic diabetes. We previously found that a theory-based outreach message containing a streamlined values affirmation-two sentences prompting individuals to reflect on core personal values-increased women's likelihood of demonstrating interest in a preventive program. Extending this work, this pilot trial tests whether the values affirmation outreach message is as acceptable as (non-inferior to) a standard outreach message among African-American and Latina women.
Methods: Two-arm, parallel-group, randomized trial among English- and Spanish-speaking minority women with prior GDM and overweight/obesity in a healthcare system. Within an online survey, participants are randomized to read an outreach message promoting an existing preventive program. The message contains either a values affirmation (intervention condition) or no affirmation (control condition).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Values affirmation | Experimental | In the values affirmation condition, the health outreach message contained a prompt asking participants to reflect on important personal values. |
|
| No affirmation | Active Comparator | In the "no affirmation" condition, the health outreach message appeared alone, with no values affirmation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Values affirmation | Behavioral | A health message with a prompt asking participants to reflect on important personal values |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of Health Message | Index of message acceptance: Persuasiveness (rated on a 7-point scale from not at all (1) to very (7), with higher mean scores corresponding to greater persuasiveness) | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Prevention Behavior: Information Seeking | Seeking information about prevention | Up to 2 weeks |
| Diabetes Prevention Behavior: Intention | Behavioral intention to engage in, or seeking information about preventive health services |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan D Brown, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Oakland | California | 94612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Values Affirmation | Values affirmation: A health message with a prompt asking participants to reflect on important personal values |
| FG001 | No Affirmation | No affirmation: A health message alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Values Affirmation | A health message with a prompt asking participants to reflect on important personal values |
| BG001 | No Affirmation | A health message presented alone, with no values affirmation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptance of Health Message | Index of message acceptance: Persuasiveness (rated on a 7-point scale from not at all (1) to very (7), with higher mean scores corresponding to greater persuasiveness) | Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program | Posted | Mean | Standard Deviation | units on a scale | Up to 2 weeks |
|
1 month
A priori, few risks were expected, with little to no risk of serious adverse events or mortality. Participants were given contact information to report any concerns about their safety and welfare.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Values Affirmation | Values affirmation: A health message with a prompt asking participants to reflect on important personal values |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan D. Brown | Kaiser Permanente Northern California | 5108913544 | susan.d.brown@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2018 | Jun 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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| No affirmation | Behavioral | A health message alone |
|
| Up to 2 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
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| Secondary | Diabetes Prevention Behavior: Information Seeking | Seeking information about prevention | Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program | Posted | Count of Participants | Participants | Up to 2 weeks |
|
|
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| Secondary | Diabetes Prevention Behavior: Intention | Behavioral intention to engage in, or seeking information about preventive health services | Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program | Posted | Count of Participants | Participants | Up to 2 weeks |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | No Affirmation | No affirmation: A health message alone | 0 | 41 | 0 | 41 | 0 | 41 |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |