Health Communication, Preventive Health Services
Conditions
Keywords
Diabetes, gestational, Diabetes Mellitus
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALValues affirmation
A health message with a prompt asking participants to reflect on important personal values
BEHAVIORALNo affirmation
A health message alone
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* History of gestational diabetes * Body mass index ≥25 kg/m2 * English or Spanish language
Exclusion criteria
* Current diabetes * Current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of Health Message | Up to 2 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Prevention Behavior: Information Seeking | Up to 2 weeks | Seeking information about prevention |
| Diabetes Prevention Behavior: Intention | Up to 2 weeks | Behavioral intention to engage in, or seeking information about preventive health services |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Values Affirmation A health message with a prompt asking participants to reflect on important personal values | 49 |
| No Affirmation A health message presented alone, with no values affirmation | 41 |
| Total | 90 |
Baseline characteristics
| Characteristic | Values Affirmation | No Affirmation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 41 Participants | 90 Participants |
| Age, Continuous | 36.3 years STANDARD_DEVIATION 5.5 | 37.0 years STANDARD_DEVIATION 5.2 | 36.5 years STANDARD_DEVIATION 5.3 |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latina | 36 Participants | 26 Participants | 62 Participants |
| Race/Ethnicity, Customized Race/Ethnicity More than one race/ethnicity | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black/African American | 11 Participants | 13 Participants | 24 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Not reported | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 49 participants | 41 participants | 90 participants |
| Sex: Female, Male Female | 49 Participants | 41 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 41 |
| other Total, other adverse events | 0 / 49 | 0 / 41 |
| serious Total, serious adverse events | 0 / 49 | 0 / 41 |
Outcome results
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)
Time frame: Up to 2 weeks
Population: Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Values Affirmation | Acceptance of Health Message | 5.5 units on a scale | Standard Deviation 0.9 |
| No Affirmation | Acceptance of Health Message | 5.4 units on a scale | Standard Deviation 1.2 |
p-value: 0.18t-test, 2 sided
Secondary
Diabetes Prevention Behavior: Information Seeking
Seeking information about prevention
Time frame: Up to 2 weeks
Population: Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Values Affirmation | Diabetes Prevention Behavior: Information Seeking | 30 Participants |
| No Affirmation | Diabetes Prevention Behavior: Information Seeking | 30 Participants |
Secondary
Diabetes Prevention Behavior: Intention
Behavioral intention to engage in, or seeking information about preventive health services
Time frame: Up to 2 weeks
Population: Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Values Affirmation | Diabetes Prevention Behavior: Intention | 32 Participants |
| No Affirmation | Diabetes Prevention Behavior: Intention | 34 Participants |