Preventive Health ServicesPEPNCT03550066
Patients Engaged in Prevention: Enhancing Outreach to Increase Patient Engagement in Diabetes Prevention
A study testing Values affirmation and No affirmation in people with Preventive Health Services and Health Communication, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preventive Health Services, Health Communication
- What is being tested?
- Values affirmation and No affirmation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 3 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of gestational diabetes
- Body mass index ≥25 kg/m2
- English or Spanish language
Who cannot join
- Current diabetes
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California
Oakland, California, 94612
About this study
Official title: A Self-Affirmation Intervention to Enhance Patient Outreach for Health System-based Lifestyle Programs for Diabetes Prevention
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.
Read the 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).
- Conditions
- Preventive Health Services, Health Communication
- Being tested
- Values affirmation, No affirmation
- Keywords
- Diabetes, gestational, Diabetes Mellitus
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Values affirmationBehavioural
A health message with a prompt asking participants to reflect on important personal values
No affirmationBehavioural
A health message alone
| Study group | Role | What they receive |
|---|---|---|
| Values affirmation | Experimental | In the values affirmation condition, the health outreach message contained a prompt asking participants to reflect on important personal values. Receives: Behavioral: Values affirmation |
| No affirmation | Active comparator | In the "no affirmation" condition, the health outreach message appeared alone, with no values affirmation. Receives: Behavioral: No affirmation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 2 weeks
Secondary outcomes (2)
Diabetes Prevention Behavior: Information Seeking
Seeking information about prevention
Measured: Up to 2 weeks
Diabetes Prevention Behavior: Intention
Behavioral intention to engage in, or seeking information about preventive health services
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Jun 2018
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preventive Health ServicesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan D Brown, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550066
- Sponsor's protocol ID
- CN-14-1871-H
- Other IDs
- K01DK099404, P30DK092924
- Acronym
- PEP
- Status last verified
- Apr 2023
- First submitted
- 14 May 2018
- Last updated
- 27 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Affirmation Intervention to Enhance Patient Outreach for Health System-based Lifestyle Programs for Diabetes Prevention
- ClinicalTrials.gov ID
- NCT03550066
- Acronym / sponsor ID
- PEP / CN-14-1871-H
- Conditions
- Preventive Health Services, Health Communication
- Keywords
- Diabetes, gestational, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Values affirmation | Experimental | Behavioral: Values affirmationIn the values affirmation condition, the health outreach message contained a prompt asking participants to reflect on important personal values. |
| No affirmation | Active comparator | Behavioral: No affirmationIn the "no affirmation" condition, the health outreach message appeared alone, with no values affirmation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of gestational diabetes
- Body mass index ≥25 kg/m2
- English or Spanish language
Key exclusion criteria (2 listed)
- Current diabetes
- Current pregnancy
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 |
|---|---|---|
| Values affirmationA health message with a prompt asking participants to reflect on important personal values | Behavioural | Values affirmation |
| No affirmationA health message alone | Behavioural | No affirmation |
Primary outcome
Acceptance of Health Message
Time frame: 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)
2 secondary outcomes
Diabetes Prevention Behavior: Information Seeking
Time frame: Up to 2 weeks
Diabetes Prevention Behavior: Intention
Time frame: Up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Susan D Brown, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Values affirmation and No affirmation in people with Preventive Health Services and Health Communication, run by Kaiser Permanente 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 3 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 27 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptance of Health Message (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.