PreDiabetesNCT05260983
Acceptance and Commitment Therapy Principles for Diabetes Prevention
A study testing Diabetes Prevention Education and Acceptance and Commitment Therapy and Diabetes Prevention Education Only in people with PreDiabetes and Diabetes Mellitus, Type 2, run by University of Oregon at 1 site in United States.
Trial summary
The investigators will evaluate whether a brief intervention (i.e. a workbook and video presenting educational information and activities materials for diabetes prevention) that incorporates principles drawn from focused Acceptance and Commitment Therapy frameworks impact positive and negative affect, stress… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, Diabetes Mellitus, Type 2, Diabetes
- What is being tested?
- Diabetes Prevention Education and Acceptance and Commitment Therapy and Diabetes Prevention Education Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2021to 21 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- United States Residency
- 90% or higher Human Intelligence Task completion ratings (ratings which are assigned by mTurk researchers to workers upon completion of a Human Intelligence Task , and to indicate quality of worker history with mTurk).
- At least 18 years of age
- English-speaking
- High-risk for Type 2 Diabetes, as indicated by a score of 5 or greater on the American Diabetes Association's diabetes risk test.
Who cannot join
- Having been enrolled in a lifestyle program for diabetes prevention presently or within the past year.
- Type 1 Diabetes diagnosis
- Type 2 Diabetes diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oregon - Social Affective Neuroscience Lab
Eugene, Oregon, 97403
About this study
Official title: Preventing Type 2 Diabetes Through Using Acceptance and Commitment Therapy Principles to Target Illness Perceptions and Controllability Awareness in Educational Materials
The investigators will evaluate whether a brief intervention (i.e. a workbook and video presenting educational information and activities materials for diabetes prevention) that incorporates principles drawn from focused Acceptance and Commitment Therapy frameworks impact positive and negative affect, stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, stress, diabetes distress, weight stigma internalization, controllability awareness, psychological flexibility, and self-efficacy - compared to standard diabetes prevention education materials.
Read the detailed description
The investigators aim for this study to represent community-based, participatory research which is accessible, effective, understandable, and minimizing of stigma. Prior to conducting the study, the investigators will develop a community advisory board, consisting of practitioners who have expertise with the development and delivery of the intervention material and study population. Advisory board members will review the study materials and provide feedback for refining the study via meetings with the Principle Investigator. In addition, the investigators will hold a focus group composed of members of the community who have prediabetes or Type 2 Diabetes and who are interested in contributing to the study design. The focus group participants will review the study materials and provide feedback for improvement in understandability, minimizing stigma, effectiveness, access and relatability to the general public. Content from the community advisory board meetings and focus group will be used to inform the study design and will not be used for dissemination of data.
For the study implementation, the investigators will distribute online questionnaires on Amazon's Mechanical Turk and use CloudResearch service to recruit participants and manage the online project. Amazon's Mechanical Turk hosts research opportunities, called Human Intelligence Tasks, to online "workers". To distribute our surveys to this participant pool the investigators will embed our Qualtrics survey link in each Human Intelligence Tasks. The description of study purpose, time commitment, and research method will be available to the online "workers" who meet the inclusion criteria set on CloudResearch.
Participants will be assessed for eligibility (see below) via a qualtrics survey sent via Amazon Mechanical turk. As the eligibility process screens for risk of diabetes and assesses perceived stress, socioeconomic indicators, health status, and state anxiety, participants will also complete an initial consent form prior to eligibility screening. This process generates three distinct participant groups: study 1 ("Randomized Control Trial"), study 2 ("Cross-Sectional") and study 3 ("Sub-study"). The summary of measures given to each group is outlined in Table 1 below.
Study 1 ("Randomized Control Trial"): Participants will complete "pre-intervention measures" to assess individual differences (diabetes risk, diabetes program prevention participation, socioeconomic status, subjective social standing, co-morbidities, health status, illness perceptions, self-efficacy, and perceived stress). Participants will be randomized into either a brief standard diabetes education intervention or a brief diabetes education and acceptance and commitment therapy intervention. Acceptance and Commitment Therapy-informed materials will retain facts about the condition, but will modify health messaging (adapted from the Center for Diseases Control and Prevention's National Diabetes Prevention Program) to clarify common inaccurate illness perceptions, reduce body size discrimination, and encourage psychological flexibility through framing illness perceptions, controllability awareness (i.e. ability to distinguish modifiable from unmodifiable components), non-judgmental awareness of what is occurring, willingness to allow experiences to occur, and the ability to step back from cognitions, acting according to personal values. Following, participants will complete "post-intervention measures" to assess psychosocial variables (i.e. stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, acute stress, diabetes distress, diabetes locus of control, self-efficacy, controllability awareness, psychological flexibility, and self-efficacy).
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2, Diabetes, Diabetes type2
- Being tested
- Diabetes Prevention Education and Acceptance and Commitment Therapy, Diabetes Prevention Education Only
- Keywords
- diabetes, diabetes-related distress, diabetes self-management, illness perceptions, acceptance and commitment therapy, controllability awareness, psychological flexibility, body size stigma
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention Education and Acceptance and Commitment TherapyBehavioural
A brief diabetes prevention education and acceptance and commitment therapy engagement facilitation intervention. Acceptance and Commitment Therapy-informed materials (i.e. video, workbook, and activities) will retain facts about the condition, but will modify health messaging to clarify common inaccurate illness perceptions, reduce body size discrimination, and encourage psychological flexibility through framing illness perceptions, controllability awareness (i.e. ability to distinguish modifiable from unmodifiable components), non-judgmental awareness of what is occurring, willingness to allow experiences to occur, and the ability to step back from cognitions, acting according to personal values.
Diabetes Prevention Education OnlyBehavioural
A brief standard diabetes prevention education engagement facilitation intervention modeled from the Center for Disease Control and Preventions's National Diabetes Prevention Program.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Prevention Education Only | Active comparator | A brief standard diabetes prevention education engagement facilitation intervention modeled from the Center for Diseases Control and Prevention's National Diabetes Prevention Program. Receives: Behavioral: Diabetes Prevention Education Only |
| Diabetes Prevention Education and Acceptance and Commitment Therapy | Experimental | A brief diabetes prevention education and acceptance and commitment therapy engagement facilitation intervention. Acceptance and Commitment Therapy-informed materials (i.e. video, workbook, and activities) will retain facts about the condition, but will modify health messaging to clarify common inaccurate illness perceptions, reduce body size discrimination, and encourage psychological flexibility through framing illness perceptions, controllability awareness (i.e. ability to distinguish modifiable from unmodifiable components), non-judgmental awareness of what is occurring, willingness to allow experiences to occur, and the ability to step back from cognitions, acting according to personal values. Receives: Behavioral: Diabetes Prevention Education and Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Modified) Brief Diabetes Risk-Related Distress
The Diabetes Risk Distress Scale is a 5-item survey designed to measure patient concerns about diabetes prevention efforts and emotional burden of diabetes risk. The scale is modified for use in populations at high-risk of developing diabetes from the Brief Diabetes Distress Scale, with the inclusion of an additional item from the original 17-item Diabetes Distress Scale . Responses are collected using a 6-point likert scale ranging from "Not a problem" (1) to "A Very Serious Problem" (6), with higher scores reflecting higher levels of diabetes distress. Two subscales will also be considered: emotional burden and diabetes distress.
Measured: Directly following the intervention
Brief Illness Perceptions Questionnaire
The Brief Illness Perceptions Questionnaire is a 9-item survey to rapidly assess the cognitive and emotional representations of illness tailored to focus on illness perceptions regarding diabetes risk. There are 5 items to measure cognitive representation of illness perceptions: consequences, timeline, personal control, treatment control, identity; two items to measure emotional representation: concern and emotional response; one item to measure illness comprehensibility / understanding; and one item designed to assess causal representation which asks participants to "rank-order the three most important factors that [the participant] believe caused [the participants] diabetes risk." Responses for the first 8 items are collected on an eleven-point Likert scale (e.g. Not at all affected emotionally (0) to Extremely affected emotionally (10)), where higher scores reflect a more extreme illness perception. Causal representation is an open-ended response.
Measured: Directly following the intervention
Expected Diabetes Prevention-Related Controllability Awareness Scale
The Expected Diabetes Prevention-Related Controllability Awareness Scale is a 20- item survey designed to measure ''controllability awareness,": the extent to which the individual's behavioral and emotional responses to daily life situations reflect awareness of the controllable and uncontrollable aspects of the outcomes of those situations without focusing explicitly on controllability distinctions. The inventory was developed to assess controllability awareness as a characteristic of stress tolerance. The inventory consists of 20 simple statements assessing awareness of various aspects of controllability including personal control, shared control, others in control, and no one in control. Subjects indicate how much they agree or disagree with each statement from 1 = disagree strongly to 5 = agree strongly. Scores from all items are summed for a scoring running from 20-100, where higher scores reflect higher levels of controllability awareness.
Measured: Directly following the intervention
Expected Program-Related Controllability Awareness Scale
The Expected Program-Related Controllability Awareness Scale was created to measure ''controllability awareness',": how much an individual's behavioral and emotional responses to daily life situations reflect awareness of the controllable and uncontrollable aspects of the outcomes of those situations without focusing explicitly on controllability distinctions. . Participants are provided a description of controllability awareness and then about the degree to which they agree with the statement "A diabetes prevention program like this one would help me prevent diabetes by teaching me to pay attention to the things about my situation that I can change and the things about my situation that I cannot change". Subjects indicate how much they agree or disagree with the statement on a 5-point scale from 1 = disagree strongly to 5 = agree strongly, where higher scores reflect higher controllability awareness.
Measured: Directly following the intervention
Personalized Psychological Flexibility Index-Diabetes Prevention
The Personalized Psychological Flexibility Index-Diabetes Prevention is a 15-item survey designed to measure the ability to pursue valued life aims despite the presence of distress, which is a fundamental contributor to health. The index measures tendencies to avoid, accept, and harness discomfort during valued goal pursuit. For this study, we modified the scale to tailor the wording to goals related to diabetes prevention. In this study, three subscales are calculated: Avoidance subscale, Acceptance subscale, and Harnessing subscale. Items are measured on a 7 point likert scale of "strongly disagree" (1) to "strongly agree" (7). Psychological flexibility scores are computed by summing all items and range from 15-105, with higher scores reflecting more challenge in pursuing valued life goals despite presence of distress.
Measured: Directly following the intervention
Brief Health Belief Model
The Brief Health Belief Model measure is designed to assess patient beliefs about the perceived seriousness ("If someone had Type 2 Diabetes or another related disease (such as stroke or heart disease), their whole life would change"), perceived susceptibility ("It is likely that I will get Type 2 Diabetes or another related disease (such as stroke or heart disease"), perceived prevention program benefits ("If I do a lifestyle change program for diabetes prevention it will decrease my chances of getting Type 2 Diabetes"), confidence ("I am confident that I could do what is recommended in the Diabetes Prevention Program if I wanted to"), and health motivation ("Maintaining good health is extremely important to me"). Each item is scored from 1 to 5 based on a Likert scale: "I strongly disagree" (1 point), "I disagree" (2 points), "I am not sure" (3 points), "I agree" (4 points), and "I strongly agree" (5 points).
Measured: Directly following the intervention
Phenomenological Body Shame Scale - Revised
The Phenomenological Body Shame Scale - Revised is an 8 item survey derived from the original 18 item Phenomenological Body Shame Scale designed to measure the motivational and behavioral components of experiencing shame when participants imagine looking at themselves in a mirror, such as the desire to hide, escape, or disappear. Sample statements include "These diabetes education materials made me feel like covering my body." and "These diabetes education materials made me wish I were invisible." and are measured on a 5 point likert scale ranging from "not at all" scored as 1 to "extremely" scored as 5. Possible scores range from 8 to 40 with higher scores reflecting higher body shame.
Measured: Directly following the intervention
Secondary outcomes (2)
(Modified) 3-item Positive and Negative Affect
The Positive and Negative Affect Scale is a 20-item scale to assess momentary positive (e.g. active, excited, proud) and negative (e.g. afraid, scared, nervous) affect . We modified the Positive and Negative Affect Scale to be a brief 3-item version of the survey which measures overall positive and overall negative affect with examples reflecting the original scale items. This version additionally measures overall stress (e.g. out of control, overwhelmed by difficulties) during the intervention module. The items are prefaced with "While participating in this diabetes prevention module, to what extent did [the participant] feel:", followed by a likert scale ranging from very slightly or not at all (1) to extremely (5). Items for the brief 3-item Positive and Negative Affect Scale are considered individually and each score ranges from 1 to 5, with higher scores reflecting higher positive emotions, higher negative emotions, and higher stress.
Measured: Directly following the intervention
Short-form State-Trait Anxiety Inventory
The Spielberger State-Trait Anxiety Inventory is a 6-item questionnaire designed and validated. It is a reliable and sensitive measure of anxiety. The 6-item version has been shown to have acceptable reliability , producing similar scores as the full 20-item inventory for those with normal and raised levels of anxiety. Participants are prompted to respond to indicate "how [the participant] feel right now, at this moment", followed by a list of common experiences (e.g. "I feel calm"," and "I am tense"). Responses range from Not at all (1) to Very much (4), with overall scores ranging from 20-80, where higher scores reflect higher states of anxiety.
Measured: Directly following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start28 Aug 2021
- Primary completion4 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Lipsett, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260983
- Sponsor's protocol ID
- STUDY00000198
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lipsett M, Berkman E. A randomized controlled trial of an acceptance and commitment therapy-informed diabetes prevention program reduces body shame and distress. Health Psychol. 2025 May;44(5):549-559. doi: 10.1037/hea0001434.
PubMed 40232790
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Type 2 Diabetes Through Using Acceptance and Commitment Therapy Principles to Target Illness Perceptions and Controllability Awareness in Educational Materials
- ClinicalTrials.gov ID
- NCT05260983
- Acronym / sponsor ID
- STUDY00000198
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2, Diabetes, Diabetes type2
- Keywords
- diabetes, diabetes-related distress, diabetes self-management, illness perceptions, acceptance and commitment therapy, controllability awareness, psychological flexibility, body size stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate whether a brief intervention (i.e. a workbook and video presenting educational information and activities materials for diabetes prevention) that incorporates principles drawn from focused Acceptance and Commitment Therapy frameworks impact positive and negative affect, stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, stress, diabetes distress, weight stigma internalization, controllability awareness, psychological flexibility, and self-efficacy - compared to standard diabetes prevention education materials.
Detailed description
The investigators aim for this study to represent community-based, participatory research which is accessible, effective, understandable, and minimizing of stigma. Prior to conducting the study, the investigators will develop a community advisory board, consisting of practitioners who have expertise with the development and delivery of the intervention material and study population. Advisory board members will review the study materials and provide feedback for refining the study via meetings with the Principle Investigator. In addition, the investigators will hold a focus group composed of members of the community who have prediabetes or Type 2 Diabetes and who are interested in contributing to the study design. The focus group participants will review the study materials and provide feedback for improvement in understandability, minimizing stigma, effectiveness, access and relatability to the general public. Content from the community advisory board meetings and focus group will be used to inform the study design and will not be used for dissemination of data.
For the study implementation, the investigators will distribute online questionnaires on Amazon's Mechanical Turk and use CloudResearch service to recruit participants and manage the online project. Amazon's Mechanical Turk hosts research opportunities, called Human Intelligence Tasks, to online "workers". To distribute our surveys to this participant pool the investigators will embed our Qualtrics survey link in each Human Intelligence Tasks. The description of study purpose, time commitment, and research method will be available to the online "workers" who meet the inclusion criteria set on CloudResearch.
Participants will be assessed for eligibility (see below) via a qualtrics survey sent via Amazon Mechanical turk. As the eligibility process screens for risk of diabetes and assesses perceived stress, socioeconomic indicators, health status, and state anxiety, participants will also complete an initial consent form prior to eligibility screening. This process generates three distinct participant groups: study 1 ("Randomized Control Trial"), study 2 ("Cross-Sectional") and study 3 ("Sub-study"). The summary of measures given to each group is outlined in Table 1 below.
Study 1 ("Randomized Control Trial"): Participants will complete "pre-intervention measures" to assess individual differences (diabetes risk, diabetes program prevention participation, socioeconomic status, subjective social standing, co-morbidities, health status, illness perceptions, self-efficacy, and perceived stress). Participants will be randomized into either a brief standard diabetes education intervention or a brief diabetes education and acceptance and commitment therapy intervention. Acceptance and Commitment Therapy-informed materials will retain facts about the condition, but will modify health messaging (adapted from the Center for Diseases Control and Prevention's National Diabetes Prevention Program) to clarify common inaccurate illness perceptions, reduce body size discrimination, and encourage psychological flexibility through framing illness perceptions, controllability awareness (i.e. ability to distinguish modifiable from unmodifiable components), non-judgmental awareness of what is occurring, willingness to allow experiences to occur, and the ability to step back from cognitions, acting according to personal values. Following, participants will complete "post-intervention measures" to assess psychosocial variables (i.e. stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, acute stress, diabetes distress, diabetes locus of control, self-efficacy, controllability awareness, psychological flexibility, and self-efficacy).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Prevention Education Only | Active comparator | Behavioral: Diabetes Prevention Education OnlyA brief standard diabetes prevention education engagement facilitation intervention modeled from the Center for Diseases Control and Prevention's National Diabetes Prevention Program. |
| Diabetes Prevention Education and Acceptance and Commitment Therapy | Experimental | Behavioral: Diabetes Prevention Education and Acceptance and Commitment TherapyA brief diabetes prevention education and acceptance and commitment therapy engagement facilitation intervention. Acceptance and Commitment Therapy-informed materials (i.e. video, workbook, and activities) will retain facts about the condition, but will modify health messaging to clarify common inaccurate illness perceptions, reduce body size discrimination, and encourage psychological flexibility through framing illness perceptions, controllability awareness (i.e. ability to distinguish modifiable from unmodifiable components), non-judgmental awareness of what is occurring, willingness to allow experiences to occur, and the ability to step back from cognitions, acting according to personal values. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- United States Residency
- 90% or higher Human Intelligence Task completion ratings (ratings which are assigned by mTurk researchers to workers upon completion of a Human Intelligence Task , and to indicate quality of worker history with mTurk).
- At least 18 years of age
- English-speaking
- High-risk for Type 2 Diabetes, as indicated by a score of 5 or greater on the American Diabetes Association's diabetes risk test.
Key exclusion criteria (3 listed)
- Having been enrolled in a lifestyle program for diabetes prevention presently or within the past year.
- Type 1 Diabetes diagnosis
- Type 2 Diabetes diagnosis
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 |
|---|---|---|
| Diabetes Prevention Education and Acceptance and Commitment TherapyA brief diabetes prevention education and acceptance and commitment therapy engagement facilitation intervention. Acceptance and Commitment Therapy-informed materials (i.e. video, workbook, and activities) will retain facts about the condition, but will modify health messaging to clarify common inaccurate illness perceptions, reduce body size discrimination, and encourage psychological flexibility through framing illness perceptions, controllability awareness (i.e. ability to distinguish modifiable from unmodifiable components), non-judgmental awareness of what is occurring, willingness to allow experiences to occur, and the ability to step back from cognitions, acting according to personal values. | Behavioural | Diabetes Prevention Education and Acceptance and Commitment Therapy |
| Diabetes Prevention Education OnlyA brief standard diabetes prevention education engagement facilitation intervention modeled from the Center for Disease Control and Preventions's National Diabetes Prevention Program. | Behavioural | Diabetes Prevention Education Only |
Primary outcome
(Modified) Brief Diabetes Risk-Related Distress
Time frame: Directly following the intervention
The Diabetes Risk Distress Scale is a 5-item survey designed to measure patient concerns about diabetes prevention efforts and emotional burden of diabetes risk. The scale is modified for use in populations at high-risk of developing diabetes from the Brief Diabetes Distress Scale, with the inclusion of an additional item from the original 17-item Diabetes Distress Scale . Responses are collected using a 6-point likert scale ranging from "Not a problem" (1) to "A Very Serious Problem" (6), with higher scores reflecting higher levels of diabetes distress. Two subscales will also be considered: emotional burden and diabetes distress.
Brief Illness Perceptions Questionnaire
Time frame: Directly following the intervention
The Brief Illness Perceptions Questionnaire is a 9-item survey to rapidly assess the cognitive and emotional representations of illness tailored to focus on illness perceptions regarding diabetes risk. There are 5 items to measure cognitive representation of illness perceptions: consequences, timeline, personal control, treatment control, identity; two items to measure emotional representation: concern and emotional response; one item to measure illness comprehensibility / understanding; and one item designed to assess causal representation which asks participants to "rank-order the three most important factors that [the participant] believe caused [the participants] diabetes risk." Responses for the first 8 items are collected on an eleven-point Likert scale (e.g. Not at all affected emotionally (0) to Extremely affected emotionally (10)), where higher scores reflect a more extreme illness perception. Causal representation is an open-ended response.
Expected Diabetes Prevention-Related Controllability Awareness Scale
Time frame: Directly following the intervention
The Expected Diabetes Prevention-Related Controllability Awareness Scale is a 20- item survey designed to measure ''controllability awareness,": the extent to which the individual's behavioral and emotional responses to daily life situations reflect awareness of the controllable and uncontrollable aspects of the outcomes of those situations without focusing explicitly on controllability distinctions. The inventory was developed to assess controllability awareness as a characteristic of stress tolerance. The inventory consists of 20 simple statements assessing awareness of various aspects of controllability including personal control, shared control, others in control, and no one in control. Subjects indicate how much they agree or disagree with each statement from 1 = disagree strongly to 5 = agree strongly. Scores from all items are summed for a scoring running from 20-100, where higher scores reflect higher levels of controllability awareness.
Expected Program-Related Controllability Awareness Scale
Time frame: Directly following the intervention
The Expected Program-Related Controllability Awareness Scale was created to measure ''controllability awareness',": how much an individual's behavioral and emotional responses to daily life situations reflect awareness of the controllable and uncontrollable aspects of the outcomes of those situations without focusing explicitly on controllability distinctions. . Participants are provided a description of controllability awareness and then about the degree to which they agree with the statement "A diabetes prevention program like this one would help me prevent diabetes by teaching me to pay attention to the things about my situation that I can change and the things about my situation that I cannot change". Subjects indicate how much they agree or disagree with the statement on a 5-point scale from 1 = disagree strongly to 5 = agree strongly, where higher scores reflect higher controllability awareness.
Personalized Psychological Flexibility Index-Diabetes Prevention
Time frame: Directly following the intervention
The Personalized Psychological Flexibility Index-Diabetes Prevention is a 15-item survey designed to measure the ability to pursue valued life aims despite the presence of distress, which is a fundamental contributor to health. The index measures tendencies to avoid, accept, and harness discomfort during valued goal pursuit. For this study, we modified the scale to tailor the wording to goals related to diabetes prevention. In this study, three subscales are calculated: Avoidance subscale, Acceptance subscale, and Harnessing subscale. Items are measured on a 7 point likert scale of "strongly disagree" (1) to "strongly agree" (7). Psychological flexibility scores are computed by summing all items and range from 15-105, with higher scores reflecting more challenge in pursuing valued life goals despite presence of distress.
Brief Health Belief Model
Time frame: Directly following the intervention
The Brief Health Belief Model measure is designed to assess patient beliefs about the perceived seriousness ("If someone had Type 2 Diabetes or another related disease (such as stroke or heart disease), their whole life would change"), perceived susceptibility ("It is likely that I will get Type 2 Diabetes or another related disease (such as stroke or heart disease"), perceived prevention program benefits ("If I do a lifestyle change program for diabetes prevention it will decrease my chances of getting Type 2 Diabetes"), confidence ("I am confident that I could do what is recommended in the Diabetes Prevention Program if I wanted to"), and health motivation ("Maintaining good health is extremely important to me"). Each item is scored from 1 to 5 based on a Likert scale: "I strongly disagree" (1 point), "I disagree" (2 points), "I am not sure" (3 points), "I agree" (4 points), and "I strongly agree" (5 points).
Phenomenological Body Shame Scale - Revised
Time frame: Directly following the intervention
The Phenomenological Body Shame Scale - Revised is an 8 item survey derived from the original 18 item Phenomenological Body Shame Scale designed to measure the motivational and behavioral components of experiencing shame when participants imagine looking at themselves in a mirror, such as the desire to hide, escape, or disappear. Sample statements include "These diabetes education materials made me feel like covering my body." and "These diabetes education materials made me wish I were invisible." and are measured on a 5 point likert scale ranging from "not at all" scored as 1 to "extremely" scored as 5. Possible scores range from 8 to 40 with higher scores reflecting higher body shame.
2 secondary outcomes
(Modified) 3-item Positive and Negative Affect
Time frame: Directly following the intervention
Short-form State-Trait Anxiety Inventory
Time frame: Directly following the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 40232790Lipsett M, Berkman E. A randomized controlled trial of an acceptance and commitment therapy-informed diabetes prevention program reduces body shame and distress. Health Psychol. 2025 May;44(5):549-559. doi: 10.1037/hea0001434.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Education and Acceptance and Commitment Therapy and Diabetes Prevention Education Only in people with PreDiabetes and Diabetes Mellitus, Type 2, run by University of Oregon 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 5 inclusion and 3 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 2 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
(Modified) Brief Diabetes Risk-Related Distress (time frame: Directly following the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260983, which also lists 1 linked publication.
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 2 Mar 2022.