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Using Peer Support to Aid in Prevention and Treatment in Prediabetes

UPSTART: Using Peer Support to Aid in Prevention and Treatment in Prediabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03689530
Acronym
UPSTART
Enrollment
450
Registered
2018-09-28
Start date
2018-10-02
Completion date
2022-04-15
Last updated
2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PreDiabetes

Keywords

peer support

Brief summary

An estimated 86 million adults in the United States have prediabetes, and low-income Latino and African American adults have disproportionately high rates compared to non-Hispanic adults. Structured lifestyle interventions can prevent or delay type 2 diabetes in these at-risk populations and now are widely offered at community organizations and health systems. Yet, uptake of and engagement in available formal programs is very low. Low-income adults in particular face multiple barriers to navigating, engaging in, and sustaining involvement in available programs and lifestyle behaviors found to decrease progression to diabetes. It is critically important to develop and evaluate innovative approaches to increase uptake, engagement, and maintenance of gains in diabetes prevention activities. Peer support has been shown in the investigators' and others' effectiveness trials to be a sustainable, effective approach for positive behavior change and improved outcomes in adults with diabetes and other chronic conditions. The study team's pilot work suggests such approaches are feasible and acceptable among low-income Latino and African American patients with prediabetes to prevent chronic disease and better navigate their health care systems to obtain healthy lifestyle counseling and support. However, such peer support models among Latino, African American, and other low-income adults with prediabetes have not yet been rigorously evaluated. Accordingly, the study will conduct a parallel, two-arm randomized controlled trial in primary care centers in two different health systems that serve multi-ethnic communities with a high concentration of Latinos and African Americans and diverse socio-economic backgrounds. The study will compare enhanced usual care (providing referrals to diabetes prevention programs and resources) with a model of a structured behavioral change intervention supplementing enhanced referral to programs and resources with peer support to help link adults with prediabetes to existing health system and community diabetes prevention programs, to support their engagement in formal programs, maintain achieved gains, and support participants to initiate and sustain healthy behaviors to prevent diabetes.

Detailed description

The intervention seeks to address the need to test in routine primary care evidence-based approaches to increase uptake, engagement, and maintenance of healthy behaviors necessary to decrease progression to diabetes among primary care patients with prediabetes, especially low-income and racial and ethnic minority adults with prediabetes. The study will conduct a parallel, two-armed, randomized controlled pragmatic clinical trial including adults with prediabetes at two primary care centers in two different health systems: Kaiser Permanente Northern California and the University of Michigan Health System. Each health system received IRB approval from its own IRB to accommodate site-specific nuances in its implementation. The trial will evaluate whether adding a 12-month predominantly telephone-based volunteer peer support program (UPSTART) to health care provider counseling and referral to diabetes prevention programs leads to greater improvements in A1c, the weight loss, and waist circumference than health care provider counseling and referral alone (Aim 1). The study will also compare differences in reported physical activity, diet, and enrollment and engagement in diabetes prevention programs as potential mediators as well as autonomous motivation, behavior-specific self-efficacy, patient activation, and perceived support; and moderators such as health literacy (Aim 2). To enhance adoption of the intervention by the two study health systems and dissemination to other health systems if effective, the study will evaluate costs and use an integrated RE-AIM and Consolidated Framework for Implementation Research (CFIR) framework to evaluate processes of intervention implementation in the two primary care settings (Aim 3). The study duration will be 5 years, to allow for peer supporter and patient recruitment, completion of the 12-month program, and assessment of outcomes at 6 months and at 12 months. The study will use mixed methods-i.e., the collection, analysis, and combining of both quantitative and qualitative data-to investigate elements important for implementation and dissemination. The study will gather data on how peer supporters, primary care clinic staff, and patients experience the intervention and how the experiences of participants together with the trial's results suggest the study should modify the intervention. Using this approach, the study aim to ensure that the intervention has the greatest possible likelihood of adoption in both UMHS and KPNC health systems should the study find it has positive effects on processes and outcomes of care. The UPSTART intervention is designed for peers to interact and provide support in a way that is autonomy supportive with the goal of enhancing autonomous motivation and self-efficacy for healthy behaviors. The study will hold periodic initial trainings for new peer supporters over the study period. In addition, peer supporters will receive: 1) routine, structured check-ins that will include monthly peer support group meetings (with option to call in) to allow exchange; 2) back-up support: offering peer supporters contact information for staff who they can call; and 3) continuing education and booster training at the monthly group meetings to enrich their skill sets and knowledge. The peer supporters were included in the total number of participant numbers for the trial and in the intervention arm in the study flow portion of this record because they were consented. Demographic characteristics of the peer supporters are also reported. However, they were not randomized; they were recruited to deliver the intervention to recruited participants with prediabetes whose outcomes we aimed to improve through the delivered intervention. The peer supporters' involvement was to deliver the intervention to the participants who were randomized to either receive the peer support intervention or to enhanced usual care. The study consented the peer supporters because they completed surveys at three time points; the intent was to look at whether delivering the intervention affected the peer supporters' own reported behaviors as exploratory only. There was and is no intention to compare coach data to primary, secondary, or any other outcome measures of the randomized participants in the trial. During the trial, another primary care center within the University of Michigan Health System was added. Because this center was within the University of Michigan Health System, and all contact information was identical, there was no reason to add another participating site.

Interventions

BEHAVIORALPeer Support

Participants will be paired with a peer supporter. They will meet in person one time and then be in contact by phone or texting on a weekly basis for the first 6 months of a year. During the final six months of the year, the peer supporter and participant will be in touch at least monthly. The peer supporter will help link participants to existing health system and community diabetes prevention programs, support their engagement in formal programs, maintain achieved gains, and support participants to initiate and sustain healthy behaviors to prevent diabetes. The 95 peer supporters who consented to participate in the study are included in this arm, along with the participants who were randomized to this arm, in the participant flow. The peer supporters were not randomized to the arm; rather, they consented to deliver the intervention. Although 95 consented, only 68 met with at least one peer, the first step in intervention delivery.

BEHAVIORALEnhanced Usual Care

Participants will receive brief education and folder of information and resources.

Sponsors

Kaiser Foundation Research Institute
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

Peer supporter: * prior A1c 5.7 - 6.4 in last 3 years, with most recent being either lass than 5.7 or 0.4 points less than prior; AND/OR * prior BMI \>=25 or \>=23 if Asian American in last three years with most recent 2% lower body weight;AND/OR * prior completion of a wellness or diabetes prevention program; AND/OR * completion of initial 6 months of UPSTART intervention as participant. Patient participant: * no prior dx of DM or current use of anti-hyperglycemic medication; * BMI \>=25 m2/kg or \>=23 if Asian; and * A1c 5.7 - 6.4.

Exclusion criteria

* serious psychiatric disorder in past 24 months * pregnant or planning pregnancy * substance abuse in past 12 months * diagnosis of dementia, bipolar, schizophrenia, personality disorder * other serious concerns rendering possible development of diabetes unimportant to potential participant.

Design outcomes

Primary

MeasureTime frameDescription
Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Monthsbaseline to 6 monthsAn A1C test measures the percentage of red blood cells that have glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher levels of blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages.
Change in Body Weight at 6 Monthsbaseline to 6 monthsbody weight in kilograms

Secondary

MeasureTime frameDescription
Change in Whether Participant Enrolled in a Formal Program to Prevent Diabetesbaseline through 12 monthsone item with yes/no response. Results indicate percentage of participants who responded yes.
Change in Number of Sessions Participant Attended in a Formal Program to Prevent Diabetesbaseline through 12 monthsone item that asks participant to report number of sessions attended
Change in Frequency and Duration Participant Engages in Moderate to Vigorous Physical Activity as Shown by Minutes Per Weekbaseline through 12 monthsThis combined measure is based on participant-reported frequency and duration of moderate to vigorous physical activity, measured in minutes per week. Frequency and duration were initially registered separately. Two questions were used to calculated minutes of physical activity per week, asked in both the baseline and 12 months surveys: Q1. On average, how many days per week do you engage in moderate-to-vigorous physical activity? A1: 0-7, integer response only Q2: On average on those days, how many minutes do you engage in physical activity as this level? A2: open numeric response A1\*A2 = minutes per week (Physical Activity value) Minutes of physical activity per week reported in 12 month survey - minutes of physical activity per week in baseline survey = change in minutes per week of physical activity
Change in the Number of Times Drinking Regular Soda or Pop That Contains Sugarbaseline through 12 monthsRecorded frequency of consumption in the last 30 days. Participants could report times per day, times per week, or times over past 30 days. These reports were converted to the number of times over past 30 days participants drank regular soda or pop that contained sugar.
Change in Patient Activation as Measured by the Patient Activation Measure 13 (PAM-13)baseline through 12 monthsPAM-13 is a 13-item scale that measures participant beliefs, perceived knowledge, and confidence for engaging in behaviors related to the participant's health condition. PAM-13 has a 0-100 scale, where a low score indicates low activation (disengaged and overwhelmed) and a high score indicates high activation (patient considers self their own advocate). The difference between the score at 12 months and the score at baseline was calculated.
Change in Participant's Perceived Confidence in Their Ability to Take Steps to Prevent Diabetes Using the Williams Perceived Competence Scalebaseline through 12 monthsWilliams Perceived Competence Scale comprises 4 items measuring the participants' perception of their own ability to take steps to prevent diabetes. Responses for each individual question range from 1 (not at all true) to 7 (very true). The responses to all 4 items were averaged (range: 1-7), with higher scores on the scale indicating higher perceived competence in preventing diabetes.
Change in Autonomous Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Autonomous)baseline through 12 monthsThe Treatment Self-Regulation Questionnaire (TSRQ) consisted of 11 items that measured the participants' perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants. The TSRQ was split into two measures: autonomous and controlled. The autonomous measure consisted of 4 items that measured participants' autonomous (or internal) perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants. Responses for each individual question range from 1 (not at all true) to 7 (very true). The responses to all 4-items are averaged (range: 1-7). Higher scores indicate participants agree with more internal reasons for preventing diabetes (ex: wanting to take responsibility for my own health).
Change in the Participant's Level of Social Support Related to Improving Their Own Health Behaviors Using the Change in Health-Specific Social Support Scalebaseline through 12 monthsThe Health-Specific Social Support Scale consisted of 12 items that asked participants to indicate their level of agreement on a 6-point Likert scale (Strongly disagree \[1\] to Strongly agree \[6\]) with statements regarding accessibility of any contact they had with people in the past 3 months who were specifically also at risk for developing diabetes and could provide social support in attempts to prevent diabetes via healthy lifestyle changes. Scores for negative statements were reversed, and the total score was the sum of all scores. Total scores can range from 12 (minimum) to 72 (maximum). A higher score indicated a better outcome because it indicated a higher level of reported social support.
The Role a Participant's Peer Supporter Played in Assisting Them to Set and Reach Their Goals Using the Goal Setting and Intervention Tailoring Subscale of the Patient Assessment of Chronic Illness Care (PACIC) at 6 Months6 monthsThe goal setting and intervention tailoring subscale of the Patient Assessment of Chronic Illness Care (PACIC) consisted of 5 questions that ask the participant to state how often their peer supporter engaged in supportive behaviors regarding setting and achieving goals in order to make healthy lifestyle changes. Each question had a range of 1 (None of the time) to 5 (Always). Averaged scores range from 1 (minimum) to 5 (maximum). A higher score indicated a better outcome because it indicated that the peer perceived their partner to be more supportive.
The Role a Participant's Peer Supporter Played in Assisting Them to Set and Reach Their Goals Using the Goal Setting and Intervention Tailoring Subscale of the Patient Assessment of Chronic Illness Care (PACIC) at 12 Months12 monthsThe goal setting and intervention tailoring subscale of the Patient Assessment of Chronic Illness Care (PACIC) consisted of 5 questions that ask the participant to state how often their peer supporter engaged in supportive behaviors regarding setting and achieving goals in order to make healthy lifestyle changes. Each question had a range of 1 (None of the time) to 5 (Always). Averaged scores range from 1 (minimum) to 5 (maximum). A higher score indicated a better outcome because it indicated that the peer perceived their partner to be more supportive.
Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 Monthsbaseline through 12 monthsAn A1C test measures the percentage of red blood cells that have glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher levels of blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages.
Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 12 Months12 monthsThe Health Care Climate Questionnaire (HCCQ, long form) consisted of 15 items that asked the participants to rank their agreement with statements that indicated degree of autonomy support (Strongly Disagree \[1\] to Strongly Agree \[7\]). Total scores ranged from 1 (minimum) to 7 (maximum). A higher score indicated a better outcome because it indicated that the peer perceived their partner to be more autonomy supportive.
Change in the Number of Times Drinking Sugary Drinks Besides Pop or Sodabaseline through 12 monthsRecorded frequency of consumption in the last 30 days. Participants could report times per day, times per week, or times over past 30 days. These reports were converted to the number of times over past 30 days participants drank sugary drinks besides pop or soda.
Change in the Number of Times Eating Fruitbaseline through 12 monthsRecorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days
Change in the Number of Times Eating Vegetablesbaseline through 12 monthsOne measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days
Change in the Number of Times Eating Meals Cooked With Olive Oilbaseline through 12 monthsOne measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days
Change in the Number of Times Eating Sweets or Dessertsbaseline through 12 monthsOne measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days
Change in the Number of Times Eating Whole Grain Breads, Whole Grain Pasta, or Brown Ricebaseline through 12 monthsOne measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days
Change in the Number of Times Eating Breads, Pasta, Rolls, or Rice Made From White, Refined Grainsbaseline through 12 monthsOne measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days
Change in Controlled Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Controlled)baseline through 12 monthsThe Treatment Self-Regulation Questionnaire (TSRQ) consists of 11 items that measure participants' perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants. The TSRQ is split into two measures: autonomous and controlled. The controlled measure consists of 7 items that measure participants' controlled (or external) perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants. Responses for each individual question range from 1 (not at all true) to 7 (very true). The responses to all 7-items are averaged (range: 1-7). Higher scores indicate participants agree with more external behaviors or reasons for preventing diabetes (ex: feeling pressure to do so from others).
Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 6 Months6 monthsThe Health Care Climate Questionnaire (HCCQ, long form) consisted of 15 items that asked the participant to rank their agreement with statements that indicated degree of autonomy support (Strongly Disagree \[1\] to Strongly Agree \[7\]). Averaged scores ranged from 1 (minimum) to 7 (maximum). A higher the score indicated a better outcome because it indicated that the peer perceived their partner to be more autonomy supportive.
Change in Body Weight at 12 Monthsbaseline through 12 monthsbody weight in kilograms

Countries

United States

Participant flow

Participants by arm

ArmCount
Peer Support Arm (Intervention)
Participants randomized to peer support will be matched with a peer supporter. Peer Support: Participants will be paired with a peer supporter. They will meet in person one time and then be in contact by phone or texting on a weekly basis for the first 6 months of a year. During the final six months of the year, the peer supporter and participant will be in touch at least monthly. The peer supporter will help link participants to existing health system and community diabetes prevention programs, support their engagement in formal programs, maintain achieved gains, and support participants to initiate and sustain healthy behaviors to prevent diabetes.
272
Enhanced Usual Care (Control)
Participants randomized to enhanced usual care will receive brief education and folder of information and resources. Enhanced Usual Care: Participants will receive brief education and folder of information and resources.
178
Total450

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject5316

Baseline characteristics

CharacteristicPeer Support Arm (Intervention)TotalEnhanced Usual Care (Control)
Age, Continuous
Peer Supporters
52.9 years
STANDARD_DEVIATION 14.1
52.9 years
STANDARD_DEVIATION 14.1
Age, Continuous
Randomized Participants
55.8 years
STANDARD_DEVIATION 13
55.1 years
STANDARD_DEVIATION 13
54.4 years
STANDARD_DEVIATION 12.9
Annual Household Income
Peer Supporter
$0 - $30K
19 Participants19 Participants
Annual Household Income
Peer Supporter
>$100K
30 Participants30 Participants
Annual Household Income
Peer Supporter
$31 - $55K
21 Participants21 Participants
Annual Household Income
Peer Supporter
$56 - $100K
18 Participants18 Participants
Annual Household Income
Peer Supporter
Participant refused
7 Participants7 Participants
Annual Household Income
Randomized Participant
$0 - $30K
43 Participants76 Participants33 Participants
Annual Household Income
Randomized Participant
>$100K
56 Participants109 Participants53 Participants
Annual Household Income
Randomized Participant
$31 - $55K
24 Participants56 Participants32 Participants
Annual Household Income
Randomized Participant
$56 - $100K
39 Participants83 Participants44 Participants
Annual Household Income
Randomized Participant
Participant refused
15 Participants31 Participants16 Participants
Body Weight97.0 Kilograms
STANDARD_DEVIATION 21.9
97.0371831 Kilograms
STANDARD_DEVIATION 23.3490493
97.1 Kilograms
STANDARD_DEVIATION 24.7
Food Insecure26 Participants59 Participants33 Participants
Glycosylated Hemoglobin A1c (HbA1c)5.9 Percentage
STANDARD_DEVIATION 0.2
5.9 Percentage
STANDARD_DEVIATION 0.2
5.9 Percentage
STANDARD_DEVIATION 0.2
Highest Education Level
Peer Supporters
College 1-3 years
25 Participants25 Participants
Highest Education Level
Peer Supporters
College 4 or more years
57 Participants57 Participants
Highest Education Level
Peer Supporters
High School or Less / missing
13 Participants13 Participants
Highest Education Level
Randomized Participant
College 1-3 years
53 Participants100 Participants47 Participants
Highest Education Level
Randomized Participant
College 4 or more years
97 Participants193 Participants96 Participants
Highest Education Level
Randomized Participant
High School or Less / missing
27 Participants62 Participants35 Participants
Low Health Literacy20 Participants39 Participants19 Participants
Major Depressive Disorder Likely23 Participants49 Participants26 Participants
Properties of Neighborhood4.1 units on a scale
STANDARD_DEVIATION 0.8
4.1 units on a scale
STANDARD_DEVIATION 0.8
4.1 units on a scale
STANDARD_DEVIATION 0.7
Race/Ethnicity, Customized
Peer Supporters
African American
32 Participants32 Participants
Race/Ethnicity, Customized
Peer Supporters
Asian/Hawaiian Islander/Pacific Islander
11 Participants11 Participants
Race/Ethnicity, Customized
Peer Supporters
Hispanic
7 Participants7 Participants
Race/Ethnicity, Customized
Peer Supporters
Multiracial/Other
10 Participants10 Participants
Race/Ethnicity, Customized
Peer Supporters
White
35 Participants35 Participants
Race/Ethnicity, Customized
Randomized Participants
African American
61 Participants121 Participants60 Participants
Race/Ethnicity, Customized
Randomized Participants
Asian/Hawaiian Islander/Pacific Islander
14 Participants31 Participants17 Participants
Race/Ethnicity, Customized
Randomized Participants
Hispanic
17 Participants32 Participants15 Participants
Race/Ethnicity, Customized
Randomized Participants
Multiracial/Other
11 Participants26 Participants15 Participants
Race/Ethnicity, Customized
Randomized Participants
White
74 Participants145 Participants71 Participants
Region of Enrollment
United States
Peer Supporters
95 Participants95 Participants0 Participants
Region of Enrollment
United States
Randomized Participants
177 Participants355 Participants178 Participants
Self-Rated Health33 Participants69 Participants36 Participants
Sex: Female, Male
Peer Supporters
Female
64 Participants64 Participants
Sex: Female, Male
Peer Supporters
Male
31 Participants31 Participants
Sex: Female, Male
Randomized Participants
Female
105 Participants221 Participants116 Participants
Sex: Female, Male
Randomized Participants
Male
72 Participants134 Participants62 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1781 / 177
other
Total, other adverse events
0 / 1780 / 177
serious
Total, serious adverse events
0 / 1780 / 177

Outcome results

Primary

Change in Body Weight at 6 Months

body weight in kilograms

Time frame: baseline to 6 months

Population: Data was unavailable for 22 participants in the Intervention arm and 35 participants in the Control arm because of scheduling issues and COVID.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in Body Weight at 6 Months-1.59 KilogramsStandard Deviation 4.76
Enhanced Usual Care (Control)Change in Body Weight at 6 Months-0.70 KilogramsStandard Deviation 4.21
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.1212Mixed Models Analysis
Primary

Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Months

An A1C test measures the percentage of red blood cells that have glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher levels of blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages.

Time frame: baseline to 6 months

Population: Data was unavailable for 23 participants in the Intervention arm and 37 participants in the Control arm because of scheduling issues and COVID.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Months-0.07 PercentageStandard Deviation 0.2
Enhanced Usual Care (Control)Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Months-0.06 PercentageStandard Deviation 0.22
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.7436Mixed Models Analysis
Secondary

Change in Autonomous Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Autonomous)

The Treatment Self-Regulation Questionnaire (TSRQ) consisted of 11 items that measured the participants' perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants. The TSRQ was split into two measures: autonomous and controlled. The autonomous measure consisted of 4 items that measured participants' autonomous (or internal) perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants. Responses for each individual question range from 1 (not at all true) to 7 (very true). The responses to all 4-items are averaged (range: 1-7). Higher scores indicate participants agree with more internal reasons for preventing diabetes (ex: wanting to take responsibility for my own health).

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 18 participants from the Intervention arm and 23 from the Control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in Autonomous Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Autonomous)-0.06 score on a questionnaireStandard Deviation 0.6
Enhanced Usual Care (Control)Change in Autonomous Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Autonomous)-0.05 score on a questionnaireStandard Deviation 0.68
p-value: 0.7168Mixed Models Analysis
Secondary

Change in Body Weight at 12 Months

body weight in kilograms

Time frame: baseline through 12 months

Population: Data was unavailable for 8 participants in the Intervention arm and 19 participants in the Control arm because of scheduling issues and COVID.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in Body Weight at 12 Months-0.79 KilogramsStandard Deviation 5.99
Enhanced Usual Care (Control)Change in Body Weight at 12 Months0.22 KilogramsStandard Deviation 4.64
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.1137Mixed Models Analysis
Secondary

Change in Controlled Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Controlled)

The Treatment Self-Regulation Questionnaire (TSRQ) consists of 11 items that measure participants' perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants. The TSRQ is split into two measures: autonomous and controlled. The controlled measure consists of 7 items that measure participants' controlled (or external) perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants. Responses for each individual question range from 1 (not at all true) to 7 (very true). The responses to all 7-items are averaged (range: 1-7). Higher scores indicate participants agree with more external behaviors or reasons for preventing diabetes (ex: feeling pressure to do so from others).

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 20 participants from the intervention arm and 26 from the control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in Controlled Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Controlled)0.07 score on a questionnaireStandard Deviation 1.09
Enhanced Usual Care (Control)Change in Controlled Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Controlled)0.20 score on a questionnaireStandard Deviation 1.16
p-value: 0.5223Mixed Models Analysis
Secondary

Change in Frequency and Duration Participant Engages in Moderate to Vigorous Physical Activity as Shown by Minutes Per Week

This combined measure is based on participant-reported frequency and duration of moderate to vigorous physical activity, measured in minutes per week. Frequency and duration were initially registered separately. Two questions were used to calculated minutes of physical activity per week, asked in both the baseline and 12 months surveys: Q1. On average, how many days per week do you engage in moderate-to-vigorous physical activity? A1: 0-7, integer response only Q2: On average on those days, how many minutes do you engage in physical activity as this level? A2: open numeric response A1\*A2 = minutes per week (Physical Activity value) Minutes of physical activity per week reported in 12 month survey - minutes of physical activity per week in baseline survey = change in minutes per week of physical activity

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 20 participants from the Intervention arm and 22 from the Control arm because some participants never completed either a baseline or a 12-month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in Frequency and Duration Participant Engages in Moderate to Vigorous Physical Activity as Shown by Minutes Per Week30.00 Minutes
Enhanced Usual Care (Control)Change in Frequency and Duration Participant Engages in Moderate to Vigorous Physical Activity as Shown by Minutes Per Week7.50 Minutes
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.2117Mixed Models Analysis
Secondary

Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 Months

An A1C test measures the percentage of red blood cells that have glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher levels of blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages.

Time frame: baseline through 12 months

Population: Data was unavailable for 14 participants in the Intervention arm and 29 participants in the Control arm because of scheduling issues and COVID.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 Months-0.06 PercentageStandard Deviation 0.24
Enhanced Usual Care (Control)Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 Months-0.06 PercentageStandard Deviation 0.27
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.8839Mixed Models Analysis
Secondary

Change in Number of Sessions Participant Attended in a Formal Program to Prevent Diabetes

one item that asks participant to report number of sessions attended

Time frame: baseline through 12 months

Population: Measure was initially conceived of as a face-to-face session. However, when the trial began, additional sessions became available online because of COVID and an increase in online offerings. As a result, no data was collected for this measure.

Secondary

Change in Participant's Perceived Confidence in Their Ability to Take Steps to Prevent Diabetes Using the Williams Perceived Competence Scale

Williams Perceived Competence Scale comprises 4 items measuring the participants' perception of their own ability to take steps to prevent diabetes. Responses for each individual question range from 1 (not at all true) to 7 (very true). The responses to all 4 items were averaged (range: 1-7), with higher scores on the scale indicating higher perceived competence in preventing diabetes.

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 18 participants from the Intervention arm and 22 from the Control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in Participant's Perceived Confidence in Their Ability to Take Steps to Prevent Diabetes Using the Williams Perceived Competence Scale-0.34 units on a scaleStandard Deviation 1.32
Enhanced Usual Care (Control)Change in Participant's Perceived Confidence in Their Ability to Take Steps to Prevent Diabetes Using the Williams Perceived Competence Scale-0.52 units on a scaleStandard Deviation 1.26
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.1006Mixed Models Analysis
Secondary

Change in Patient Activation as Measured by the Patient Activation Measure 13 (PAM-13)

PAM-13 is a 13-item scale that measures participant beliefs, perceived knowledge, and confidence for engaging in behaviors related to the participant's health condition. PAM-13 has a 0-100 scale, where a low score indicates low activation (disengaged and overwhelmed) and a high score indicates high activation (patient considers self their own advocate). The difference between the score at 12 months and the score at baseline was calculated.

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 17 participants from the Intervention arm and 23 from the Control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in Patient Activation as Measured by the Patient Activation Measure 13 (PAM-13)1.12 units on a scaleStandard Deviation 13.34
Enhanced Usual Care (Control)Change in Patient Activation as Measured by the Patient Activation Measure 13 (PAM-13)1.80 units on a scaleStandard Deviation 14.13
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.8785Mixed Models Analysis
Secondary

Change in the Number of Times Drinking Regular Soda or Pop That Contains Sugar

Recorded frequency of consumption in the last 30 days. Participants could report times per day, times per week, or times over past 30 days. These reports were converted to the number of times over past 30 days participants drank regular soda or pop that contained sugar.

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 20 participants from the Intervention arm and 23 from the Control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in the Number of Times Drinking Regular Soda or Pop That Contains Sugar0.00 Times Consumed
Enhanced Usual Care (Control)Change in the Number of Times Drinking Regular Soda or Pop That Contains Sugar0.00 Times Consumed
p-value: 0.4169Mixed Models Analysis
Secondary

Change in the Number of Times Drinking Sugary Drinks Besides Pop or Soda

Recorded frequency of consumption in the last 30 days. Participants could report times per day, times per week, or times over past 30 days. These reports were converted to the number of times over past 30 days participants drank sugary drinks besides pop or soda.

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 19 participants from the Intervention arm and 24 from the Control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in the Number of Times Drinking Sugary Drinks Besides Pop or Soda0.00 Times Consumed
Enhanced Usual Care (Control)Change in the Number of Times Drinking Sugary Drinks Besides Pop or Soda0.00 Times Consumed
p-value: 0.9126Mixed Models Analysis
Secondary

Change in the Number of Times Eating Breads, Pasta, Rolls, or Rice Made From White, Refined Grains

One measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 19 participants from the intervention arm and 22 from the control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in the Number of Times Eating Breads, Pasta, Rolls, or Rice Made From White, Refined Grains-0.15 Times Consumed
Enhanced Usual Care (Control)Change in the Number of Times Eating Breads, Pasta, Rolls, or Rice Made From White, Refined Grains0.00 Times Consumed
p-value: 0.3219Mixed Models Analysis
Secondary

Change in the Number of Times Eating Fruit

Recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 19 participants from the Intervention arm and 22 from the Control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in the Number of Times Eating Fruit0.00 Times Consumed
Enhanced Usual Care (Control)Change in the Number of Times Eating Fruit0.00 Times Consumed
p-value: 0.7405Mixed Models Analysis
Secondary

Change in the Number of Times Eating Meals Cooked With Olive Oil

One measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 19 participants from the intervention arm and 23 from the control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in the Number of Times Eating Meals Cooked With Olive Oil0.00 Times Consumed
Enhanced Usual Care (Control)Change in the Number of Times Eating Meals Cooked With Olive Oil0.00 Times Consumed
p-value: 0.3341Mixed Models Analysis
Secondary

Change in the Number of Times Eating Sweets or Desserts

One measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 18 participants from the intervention arm and 22 from the control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in the Number of Times Eating Sweets or Desserts-3.60 Times Consumed
Enhanced Usual Care (Control)Change in the Number of Times Eating Sweets or Desserts-4.30 Times Consumed
p-value: 0.2049Mixed Models Analysis
Secondary

Change in the Number of Times Eating Vegetables

One measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 18 participants from the intervention arm and 22 from the control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in the Number of Times Eating Vegetables0.00 Times Consumed
Enhanced Usual Care (Control)Change in the Number of Times Eating Vegetables0.00 Times Consumed
p-value: 0.5956Mixed Models Analysis
Secondary

Change in the Number of Times Eating Whole Grain Breads, Whole Grain Pasta, or Brown Rice

One measure that recorded frequency of consumption in the last 30 days - participants could report times per day, times per week, or times over past 30 days, which was converted to times over past 30 days

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 18 participants from the intervention arm and 22 from the control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEDIAN)
Peer Support Arm (Intervention)Change in the Number of Times Eating Whole Grain Breads, Whole Grain Pasta, or Brown Rice0.00 Times Consumed
Enhanced Usual Care (Control)Change in the Number of Times Eating Whole Grain Breads, Whole Grain Pasta, or Brown Rice0.00 Times Consumed
p-value: 0.0335Mixed Models Analysis
Secondary

Change in the Participant's Level of Social Support Related to Improving Their Own Health Behaviors Using the Change in Health-Specific Social Support Scale

The Health-Specific Social Support Scale consisted of 12 items that asked participants to indicate their level of agreement on a 6-point Likert scale (Strongly disagree \[1\] to Strongly agree \[6\]) with statements regarding accessibility of any contact they had with people in the past 3 months who were specifically also at risk for developing diabetes and could provide social support in attempts to prevent diabetes via healthy lifestyle changes. Scores for negative statements were reversed, and the total score was the sum of all scores. Total scores can range from 12 (minimum) to 72 (maximum). A higher score indicated a better outcome because it indicated a higher level of reported social support.

Time frame: baseline through 12 months

Population: Survey responses/data were unavailable for 22 participants from the Intervention arm and 26 from the Control arm because some participants never completed either a baseline or a 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Change in the Participant's Level of Social Support Related to Improving Their Own Health Behaviors Using the Change in Health-Specific Social Support Scale9.34 units on a scaleStandard Deviation 12.13
Enhanced Usual Care (Control)Change in the Participant's Level of Social Support Related to Improving Their Own Health Behaviors Using the Change in Health-Specific Social Support Scale3.69 units on a scaleStandard Deviation 13.59
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.0001Mixed Models Analysis
Secondary

Change in Whether Participant Enrolled in a Formal Program to Prevent Diabetes

one item with yes/no response. Results indicate percentage of participants who responded yes.

Time frame: baseline through 12 months

Population: This measure only includes participants who, at baseline, had not enrolled in a formal program to prevent diabetes, and who answered the 12-month survey. For this reason, data was unavailable for 17 participants in the Intervention arm and 22 participants in the Control arm.

ArmMeasureValue (NUMBER)
Peer Support Arm (Intervention)Change in Whether Participant Enrolled in a Formal Program to Prevent Diabetes25 percentage of participants
Enhanced Usual Care (Control)Change in Whether Participant Enrolled in a Formal Program to Prevent Diabetes14 percentage of participants
Comparison: Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4p-value: 0.0162Mixed Models Analysis
Secondary

Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 12 Months

The Health Care Climate Questionnaire (HCCQ, long form) consisted of 15 items that asked the participants to rank their agreement with statements that indicated degree of autonomy support (Strongly Disagree \[1\] to Strongly Agree \[7\]). Total scores ranged from 1 (minimum) to 7 (maximum). A higher score indicated a better outcome because it indicated that the peer perceived their partner to be more autonomy supportive.

Time frame: 12 months

Population: Survey responses/data were unavailable for 27 participants from the Intervention arm because some participants never completed a baseline or 12-month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded. For these specific intervention-only questions, some peers were never assigned a coach and therefore skipped these questions regarding coach interactions. Participants in the Enhanced Usual Care (Control) arm were not assigned a peer supporter.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 12 Months6.18 Score on QuestionnaireStandard Deviation 1.14
Secondary

Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 6 Months

The Health Care Climate Questionnaire (HCCQ, long form) consisted of 15 items that asked the participant to rank their agreement with statements that indicated degree of autonomy support (Strongly Disagree \[1\] to Strongly Agree \[7\]). Averaged scores ranged from 1 (minimum) to 7 (maximum). A higher the score indicated a better outcome because it indicated that the peer perceived their partner to be more autonomy supportive.

Time frame: 6 months

Population: Survey responses/data were unavailable for 20 participants from the Intervention arm because some participants never completed a baseline or 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded. For these specific intervention-only questions, some peers were never assigned a coach and therefore skipped these questions regarding coach interactions. Participants in the Enhanced Usual Care (Control) arm were not assigned a peer supporter.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 6 Months6.22 score on a scaleStandard Deviation 1.08
Secondary

The Role a Participant's Peer Supporter Played in Assisting Them to Set and Reach Their Goals Using the Goal Setting and Intervention Tailoring Subscale of the Patient Assessment of Chronic Illness Care (PACIC) at 12 Months

The goal setting and intervention tailoring subscale of the Patient Assessment of Chronic Illness Care (PACIC) consisted of 5 questions that ask the participant to state how often their peer supporter engaged in supportive behaviors regarding setting and achieving goals in order to make healthy lifestyle changes. Each question had a range of 1 (None of the time) to 5 (Always). Averaged scores range from 1 (minimum) to 5 (maximum). A higher score indicated a better outcome because it indicated that the peer perceived their partner to be more supportive.

Time frame: 12 months

Population: Survey responses/data were unavailable for 27 participants from Intervention arm because some participants never completed a baseline or 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded. For these specific intervention-only questions, some peers were never assigned a coach and therefore skipped these questions regarding coach interactions. Participants in the Enhanced Usual Care (Control) arm were not assigned a peer supporter.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)The Role a Participant's Peer Supporter Played in Assisting Them to Set and Reach Their Goals Using the Goal Setting and Intervention Tailoring Subscale of the Patient Assessment of Chronic Illness Care (PACIC) at 12 Months3.73 Score on a questionnaireStandard Deviation 0.99
Secondary

The Role a Participant's Peer Supporter Played in Assisting Them to Set and Reach Their Goals Using the Goal Setting and Intervention Tailoring Subscale of the Patient Assessment of Chronic Illness Care (PACIC) at 6 Months

The goal setting and intervention tailoring subscale of the Patient Assessment of Chronic Illness Care (PACIC) consisted of 5 questions that ask the participant to state how often their peer supporter engaged in supportive behaviors regarding setting and achieving goals in order to make healthy lifestyle changes. Each question had a range of 1 (None of the time) to 5 (Always). Averaged scores range from 1 (minimum) to 5 (maximum). A higher score indicated a better outcome because it indicated that the peer perceived their partner to be more supportive.

Time frame: 6 months

Population: Survey responses/data were unavailable for 20 participants from Intervention arm because some participants never completed a baseline or 12 month survey. Additionally, KPNC allowed participants to skip survey questions, so some may not have responded. For these specific intervention-only questions, some peers were never assigned a coach and therefore skipped these questions regarding coach interactions. Participants in the Enhanced Usual Care (Control) arm were not assigned a peer supporter.

ArmMeasureValue (MEAN)Dispersion
Peer Support Arm (Intervention)The Role a Participant's Peer Supporter Played in Assisting Them to Set and Reach Their Goals Using the Goal Setting and Intervention Tailoring Subscale of the Patient Assessment of Chronic Illness Care (PACIC) at 6 Months3.79 Score on a questionnaireStandard Deviation 0.89

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026