N/A
Completed N=450
Using Peer Support to Aid in Prevention and Treatment in Prediabetes
Source: ClinicalTrials.gov NCT03689530 ↗Enrolled (actual)
450
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Months — -0.07; -0.06 Percentage — p=0.7436
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Months |
-0.07; -0.06 | 0.7436 |
| PRIMARY Change in Body Weight at 6 Months |
-1.59; -0.70 | 0.1212 |
| SECONDARY Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 Months |
-0.06; -0.06 | 0.8839 |
| SECONDARY Change in Body Weight at 12 Months |
-0.79; 0.22 | 0.1137 |
| SECONDARY Change in Whether Participant Enrolled in a Formal Program to Prevent Diabetes |
25; 14 | 0.0162 sig |
| SECONDARY Change in Number of Sessions Participant Attended in a Formal Program to Prevent Diabetes |
— | — |
| SECONDARY Change in Frequency and Duration Participant Engages in Moderate to Vigorous Physical Activity as Shown by Minutes Per Week |
30.00; 7.50 | 0.2117 |
| SECONDARY Change in the Number of Times Drinking Regular Soda or Pop That Contains Sugar |
0.00; 0.00 | 0.4169 |
| SECONDARY Change in Patient Activation as Measured by the Patient Activation Measure 13 (PAM-13) |
1.12; 1.80 | 0.8785 |
| SECONDARY Change in Participant's Perceived Confidence in Their Ability to Take Steps to Prevent Diabetes Using the Williams Perceived Competence Scale |
-0.34; -0.52 | 0.1006 |
| SECONDARY Change in Autonomous Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Autonomous) |
-0.06; -0.05 | 0.7168 |
| 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 |
9.34; 3.69 | 0.0001 sig |
| 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 |
3.79 | — |
| 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 |
3.73 | — |
| SECONDARY Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 6 Months |
6.22 | — |
| SECONDARY Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 12 Months |
6.18 | — |
| SECONDARY Change in the Number of Times Drinking Sugary Drinks Besides Pop or Soda |
0.00; 0.00 | 0.9126 |
| SECONDARY Change in the Number of Times Eating Fruit |
0.00; 0.00 | 0.7405 |
| SECONDARY Change in the Number of Times Eating Vegetables |
0.00; 0.00 | 0.5956 |
| SECONDARY Change in the Number of Times Eating Meals Cooked With Olive Oil |
0.00; 0.00 | 0.3341 |
| SECONDARY Change in the Number of Times Eating Sweets or Desserts |
-3.60; -4.30 | 0.2049 |
| SECONDARY Change in the Number of Times Eating Whole Grain Breads, Whole Grain Pasta, or Brown Rice |
0.00; 0.00 | 0.0335 sig |
| SECONDARY Change in the Number of Times Eating Breads, Pasta, Rolls, or Rice Made From White, Refined Grains |
-0.15; 0.00 | 0.3219 |
| SECONDARY Change in Controlled Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Controlled) |
0.07; 0.20 | 0.5223 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03689530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.