Trial Outcomes & Findings for Using Peer Support to Aid in Prevention and Treatment in Prediabetes (NCT NCT03689530)

Last Updated: 2023-03-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

450 participants

Primary outcome timeframe

baseline to 6 months

Results posted on

2023-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	272	178
Overall Study 6-month Follow-up	223	169
Overall Study 12-month Follow-up	212	162
Overall Study COMPLETED	219	162
Overall Study NOT COMPLETED	53	16

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	53	16

Baseline Characteristics

Demographics are presented separately by participant type: by the participants who were randomized and by the peer supporters who delivered the intervention.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=135 Participants 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.	Enhanced Usual Care (Control) n=132 Participants 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.
Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Months	-0.07 Percentage Standard Deviation 0.20	-0.06 Percentage Standard Deviation 0.22

PRIMARY outcome

Timeframe: 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.

body weight in kilograms

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=136 Participants 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.	Enhanced Usual Care (Control) n=134 Participants 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.
Change in Body Weight at 6 Months	-1.59 Kilograms Standard Deviation 4.76	-0.70 Kilograms Standard Deviation 4.21

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=137 Participants 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.	Enhanced Usual Care (Control) n=133 Participants 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.
Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 Months	-0.06 Percentage Standard Deviation 0.24	-0.06 Percentage Standard Deviation 0.27

SECONDARY outcome

Timeframe: 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.

body weight in kilograms

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=143 Participants 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.	Enhanced Usual Care (Control) n=143 Participants 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.
Change in Body Weight at 12 Months	-0.79 Kilograms Standard Deviation 5.99	0.22 Kilograms Standard Deviation 4.64

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=134 Participants 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.	Enhanced Usual Care (Control) n=140 Participants 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.
Change in Whether Participant Enrolled in a Formal Program to Prevent Diabetes	25 percentage of participants	14 percentage of participants

SECONDARY outcome

Timeframe: 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.

one item that asks participant to report number of sessions attended

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=131 Participants 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.	Enhanced Usual Care (Control) n=140 Participants 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.
Change in Frequency and Duration Participant Engages in Moderate to Vigorous Physical Activity as Shown by Minutes Per Week	30.00 Minutes Interval -40.0 to 105.0	7.50 Minutes Interval -30.0 to 75.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=131 Participants 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.	Enhanced Usual Care (Control) n=139 Participants 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.
Change in the Number of Times Drinking Regular Soda or Pop That Contains Sugar	0.00 Times Consumed Interval -3.0 to 0.0	0.00 Times Consumed Interval -1.0 to 0.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=134 Participants 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.	Enhanced Usual Care (Control) n=139 Participants 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.
Change in Patient Activation as Measured by the Patient Activation Measure 13 (PAM-13)	1.12 units on a scale Standard Deviation 13.34	1.80 units on a scale Standard Deviation 14.13

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=133 Participants 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.	Enhanced Usual Care (Control) n=140 Participants 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.
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 scale Standard Deviation 1.32	-0.52 units on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=133 Participants 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.	Enhanced Usual Care (Control) n=139 Participants 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.
Change in Autonomous Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Autonomous)	-0.06 score on a questionnaire Standard Deviation 0.60	-0.05 score on a questionnaire Standard Deviation 0.68

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=129 Participants 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.	Enhanced Usual Care (Control) n=136 Participants 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.
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	9.34 units on a scale Standard Deviation 12.13	3.69 units on a scale Standard Deviation 13.59

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=138 Participants 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.	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.
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	3.79 Score on a questionnaire Standard Deviation 0.89	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=124 Participants 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.	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.
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	3.73 Score on a questionnaire Standard Deviation 0.99	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=138 Participants 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.	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.
Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 6 Months	6.22 score on a scale Standard Deviation 1.08	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=124 Participants 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.	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.
Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 12 Months	6.18 Score on Questionnaire Standard Deviation 1.14	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=132 Participants 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.	Enhanced Usual Care (Control) n=138 Participants 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.
Change in the Number of Times Drinking Sugary Drinks Besides Pop or Soda	0.00 Times Consumed Interval -5.0 to 0.0	0.00 Times Consumed Interval -4.3 to 2.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=132 Participants 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.	Enhanced Usual Care (Control) n=140 Participants 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.
Change in the Number of Times Eating Fruit	0.00 Times Consumed Interval -10.6 to 8.6	0.00 Times Consumed Interval -8.5 to 7.55

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=133 Participants 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.	Enhanced Usual Care (Control) n=140 Participants 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.
Change in the Number of Times Eating Vegetables	0.00 Times Consumed Interval -4.3 to 8.6	0.00 Times Consumed Interval -12.8 to 12.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=132 Participants 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.	Enhanced Usual Care (Control) n=139 Participants 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.
Change in the Number of Times Eating Meals Cooked With Olive Oil	0.00 Times Consumed Interval -4.3 to 7.5	0.00 Times Consumed Interval -6.6 to 8.6

SECONDARY outcome

Timeframe: baseline through 12 months

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=133 Participants 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.	Enhanced Usual Care (Control) n=140 Participants 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.
Change in the Number of Times Eating Sweets or Desserts	-3.60 Times Consumed Interval -9.0 to 0.3	-4.30 Times Consumed Interval -16.3 to 4.3

SECONDARY outcome

Timeframe: baseline through 12 months

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=133 Participants 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.	Enhanced Usual Care (Control) n=140 Participants 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.
Change in the Number of Times Eating Whole Grain Breads, Whole Grain Pasta, or Brown Rice	0.00 Times Consumed Interval -7.6 to 8.6	0.00 Times Consumed Interval -9.25 to 4.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=132 Participants 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.	Enhanced Usual Care (Control) n=140 Participants 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.
Change in the Number of Times Eating Breads, Pasta, Rolls, or Rice Made From White, Refined Grains	-0.15 Times Consumed Interval -6.6 to 3.0	0.00 Times Consumed Interval -8.6 to 4.1

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Peer Support Arm (Intervention) n=131 Participants 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.	Enhanced Usual Care (Control) n=136 Participants 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.
Change in Controlled Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Controlled)	0.07 score on a questionnaire Standard Deviation 1.09	0.20 score on a questionnaire Standard Deviation 1.16

Adverse Events

Enhanced Usual Care (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peer Support Arm (Intervention)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michele Heisler

University of Michigan

Phone: (734) 845-3504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place