A Self-Affirmation Intervention to Enhance Patient Outreach for Health System-based Lifestyle Programs for Diabetes Prevention
Phase: NA
Conditions: Preventive Health Services, Health Communication
Sponsor: Kaiser Permanente

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A Self-Affirmation Intervention to Enhance Patient Outreach for Health System-
based Lifestyle Programs for Diabetes Prevention 
 
Study Protocol and Statistical Analysis Plan  
August 29, 2018 
 
National Clinical Trial (NCT) Identified Number: NCT03550066 
Unique protocol ID: CN-14-1871-H 
 
Principal Investigator: Susan D. Brown, PhD 
 
Sponsor: National Institutes of Health 
 
Human Subjects Approval: Kaiser Foundation Research Institute  
 
 
 
 

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Uploaded to ClinicalTrials.gov 6-28-2019 
I. Study Overview  
This pilot study examines the acceptability of a values affirmation intervention, which prompts 
participants to reflect on important personal values, embedded within a health outreach message 
encouraging participation in healthcare services for diabetes prevention (e.g., a lifestyle program for 
reduction of diabetes risk factors). This study tests whether an outreach message containing the values 
affirmation intervention is as acceptable as (non-inferior to) a standard outreach message without the 
values affirmation. Participants will be sampled from a multi-lingual, ethnically diverse population of 
women who face high risk for type 2 diabetes due to having a history of gestational diabetes mellitus 
(GDM) and elevated body mass index (BMI). This study extends prior research by including English- and 
Spanish-speaking women from African-American and Latina racial/ethnic backgrounds. The overall 
objective is to develop theory-based health messaging that is acceptable to diverse women who may 
benefit from diabetes prevention programs. 
II. Study design and methods 
Two-arm, parallel-group, randomized trial among English- and Spanish-speaking minority women with 
prior GDM and elevated BMI in a healthcare system.  
III. Hypothesis and Outcomes  
We hypothesize that an outreach message containing a values affirmation will be as acceptable to 
participants as an outreach message that does not contain a values affirmation. 
Primary outcome: Acceptability of the message, as assessed by its perceived persuasiveness (e.g., 
perceiving the message as helpful, respectful, personally relevant). Persuasiveness is assessed using a 7-
point self-report scale, with higher mean scores corresponding to greater perceived persuasiveness.  
Secondary outcomes: Whether women a) seek health information on diabetes prevention, and b) either 
seek information about or intend to join a preventive program. 
IV. Recruitment  
Potential participants will be recruited from Kaiser Permanente Northern California, a large integrated 
healthcare delivery system. Eligibility criteria include:  
o Age ≥ 18 years 
o History of gestational diabetes mellitus within the past 4 years 
o Elevated body mass index (≥ 25 kg/m2)  
o Hispanic or Black race/ethnicity 
 
Exclusion criteria include current pregnancy and current diabetes. Participants already participating in a 
lifestyle program for diabetes prevention will be excluded from analyses. 
V. Informed Consent  
Informed consent is obtained from each participant at entry into the study by the following 
process: 
1. Participants are invited to complete the study online via a secure website. On the website, 
participants are first asked to review the study consent form. 
2. A toll-free phone number and study email address are provided so that research staff can 
answer any questions that participants might have. 

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3. Participants agree to participate in the study with an electronic signature. Participants will not 
be able to proceed to the survey unless they have agreed to consent. 
4. Participants are able to save and print out a copy of the consent. 
 
VI. Procedure 
Study participation involves completing a single online survey. Within the survey, participants are 
assigned to read an outreach message promoting an existing preventive program that contains either a 
values affirmation (intervention condition) or no affirmation (control condition). Participants complete 
survey items before and after being exposed to the outreach message in their assigned condition. 
Participants receive a $10 gift card upon completion of the survey. 
VII. Adherence statement 
The Data and Safety Monitoring Plan (DSMP) outlined below for CN-14-1871-H will adhere to the 
protocol approved by the Kaiser Permanente Northern California IRB.  
VIII. Adverse Events  
A. Adverse event assessment 
Few risks are expected in the present study, with little to no risk of serious adverse events or mortality. 
Risks include the potential for participants to find the survey questions and outreach materials 
upsetting. Risks are addressed in the consent form. Steps taken to minimize risks include using materials 
based on existing, publicly available health education materials or based on established research 
instruments used in prior studies which, to our knowledge, no studies have found to be more than 
minimally upsetting. Additionally, participants are explicitly advised in the consent form that they may 
skip any questions that make them feel uncomfortable. The consent form reminds participants that they 
may seek medical care as needed as members of the Kaiser Foundation Health Plan. Participants are 
provided with study contact information to report any concerns regarding their safety and welfare.  
B. Adverse event reporting  
Applicable events reported by participants to either the principal investigator or the designated research 
associates will be documented. For each adverse event, a report will be generated including, at a 
minimum, a description of the event, when and how it was reported, and determinations of attribution 
(related or unrelated to the study) and severity. Recipients of the adverse event report will include the 
IRB in accordance with institutional policies for timeliness of reporting. Any action resulting in a 
temporary or permanent suspension of this study will be immediately reported to the appropriate 
NIDDK program official.  
IX. Safety Review Plan and Monitoring  
A. Justification of sample size 
The primary goal of the study is to examine the acceptability of a self-affirmation intervention 
embedded within an outreach message promoting patient uptake of health services for type 2 diabetes 
prevention. A sample size of 70 participants (35 per condition) for this early-stage pilot and feasibility 
project will provide adequate power to determine that there is no difference in acceptability between 
conditions (see Statistical Design and Power, below).  
B. Safety and study progress review 

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The PI will review study progress, e.g., recruitment, retention, and protocol adherence, on a weekly 
basis (and more frequently if needed). The PI will review adverse events at least monthly. No formal 
stopping points will be included. 
X. Data Quality and Management  
Study staff will review all data collection forms for completeness, accuracy, and protocol compliance 
on an ongoing basis during active data collection, and again upon completion of data collection.  
Measures taken to ensure data integrity and protection of databases: Data verification will be 
performed by study staff. The PI has consulted with Kaiser Permanente Division of Research (DOR) IT 
Development and Application Services to offer the data collection survey online. An authentication 
process will be used to ensure the privacy of user accounts. Access to survey data will be provided to 
the research team in a secure web console requiring authentication.  
XI. Confidentiality  
Risks to confidentiality will be mitigated by extensive provisions to safeguard participants’ confidential 
information. No data collection forms will have identifying information on them except for a unique 
study participant identification (ID) number. Any physical data (paper copies) will be kept in locked file 
cabinets with access limited to the study team on a need-to-know basis. The list that links study 
identification numbers with participants’ names will be maintained electronically in a password-
protected folder on our secure sever, to which only study staff will have access on a need-to-know 
basis. Access to computerized patient tracking systems and data files will be restricted to the study 
staff by the use of a password. No individual-level data will be included in any report or publication 
related to any study. All data will be reported in the aggregate. 
XII. Statistical Analysis and Power 
The primary goal of the study is to examine the acceptability of a self-affirmation intervention 
embedded within an outreach message promoting patient uptake of health services for type 2 diabetes 
prevention. The primary hypothesis is that acceptability of an outreach message that includes self-
affirmation (experimental condition) will be non-inferior to the acceptability of a standard outreach 
message without self-affirmation (no-affirmation control condition). The target sample size is 70 
participants (35 per condition) for this early-stage pilot and feasibility project. This sample size provides 
80% power to determine that there is no difference in acceptability between conditions above a non-
inferiority limit of d=.6. The primary outcome of acceptability will be examined using t-tests. Outcomes 
will be assessed by modified intent-to-treat analyses (excluding participants who already have diabetes 
or who are already participating in a lifestyle program for diabetes prevention).