An interventional study of Values affirmation and No affirmation in Preventive Health Services and Health Communication, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the values affirmation condition, the health outreach message contained a prompt asking participants to reflect on important personal values.
Behavioral: Values affirmation
In the "no affirmation" condition, the health outreach message appeared alone, with no values affirmation.
Behavioral: No affirmation
A health message with a prompt asking participants to reflect on important personal values
A health message alone
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)
Time frame: Up to 2 weeks
Diabetes Prevention Behavior: Information Seeking
Seeking information about prevention
Time frame: Up to 2 weeks
Diabetes Prevention Behavior: Intention
Behavioral intention to engage in, or seeking information about preventive health services
Time frame: Up to 2 weeks
| Milestone | Values Affirmation | No Affirmation |
|---|---|---|
| Started | 49 | 41 |
| Completed | 49 | 41 |
| Not completed | 0 | 0 |
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)
| units on a scale | Values Affirmation | No Affirmation |
|---|---|---|
| Acceptance of Health Message | 5.5 ± 0.9 | 5.4 ± 1.2 |
Seeking information about prevention
| Participants | Values Affirmation | No Affirmation |
|---|---|---|
| Diabetes Prevention Behavior: Information Seeking | 30 | 30 |
Behavioral intention to engage in, or seeking information about preventive health services
| Participants | Values Affirmation | No Affirmation |
|---|---|---|
| Diabetes Prevention Behavior: Intention | 32 | 34 |
Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Values Affirmation | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| No Affirmation | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Age, Categorical(Participants) | Values Affirmation | No Affirmation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 49 | 41 | 90 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Values Affirmation | No Affirmation | Total |
|---|---|---|---|
| Mean | 36.3 ± 5.5 | 37.0 ± 5.2 | 36.5 ± 5.3 |
| Sex: Female, Male(Participants) | Values Affirmation | No Affirmation | Total |
|---|---|---|---|
| Female | 49 | 41 | 90 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Values Affirmation | No Affirmation | Total |
|---|---|---|---|
| Race/Ethnicity — Non-Hispanic Black/African American | 11 | 13 | 24 |
| Race/Ethnicity — Hispanic/Latina | 36 | 26 | 62 |
| Race/Ethnicity — More than one race/ethnicity | 2 | 1 | 3 |
| Race/Ethnicity — Not reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Values Affirmation | No Affirmation | Total |
|---|---|---|---|
| United States | 49 | 41 | 90 |
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Plan to share: No
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