Patient-centered Goal Setting in the National Diabetes Prevention Program (NDPP-Flex)

Patient-centered Goal Setting in the National Diabetes Prevention Program: a Clinical Trial

This is a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP to evaluate effects on glycemia, heterogeneity of treatment effects, and mechanisms of change. We will recruit 200 diverse adults with prediabetes (A1C 5.7-6.4%) and normal weight or overweight/obesity. Participants will enroll in classes (N=20) that are randomized to deliver NDPP-Flex or the standard NDPP. The trial is designed to have >95% power to detect anticipated treatment effects of ~0.2% A1C improvement and ~10% increase in participants who reach normoglycemia compared to the control arm. The study will be conducted in a health system with the 6th largest network of FQHCs in the US (Denver Health) and in partnership with a premier research institution (University of Colorado).

Study Overview

• Status: Recruiting
• Conditions: PreDiabetes
• Intervention / Treatment: Behavioral: NDPP; Behavioral: NDPP-Flex

Detailed Description

Diabetes affects 13.0% of US adults, a rising trend that especially impacts racial and ethnic minority and low-income individuals. In response, the Centers for Disease Control and Prevention launched the National Diabetes Prevention Program (NDPP) in 2010 to provide evidence-based lifestyle intervention for adults with risk factors such as overweight/obesity and prediabetes (e.g., A1C 5.7-6.4%). Successes include reaching >300,000 participants and delivery in all 50 states. However, a major concern is limited effectiveness for disadvantaged groups with the highest risk of diabetes. For example, Latinx are the largest ethnic minority group in the US, but least likely to enroll in or complete the yearlong NDPP, which may widen disparities and diminish overall program impact. The NDPP focuses primarily on weight loss to reduce risk, but racial/ethnic minority and low-income groups both lose about half as much weight as white and higher-income groups, respectively (~2% vs. ~4%).

To address these challenges, we adapted the NDPP with an array of personalized goals for risk-reduction to meet individual needs (NDPP-Flex). We developed NDPP-Flex based on the Health Belief Model in which factors like personal characteristics, perceived barriers, and self-efficacy influence health outcomes. We also focused on no-cost modifications per our extensive prior research on NDPP implementation that identified both strengths (e.g., cost-effectiveness) and weaknesses (e.g., low reimbursement rates). We piloted NDPP-Flex with 95 diverse participants (e.g., 76% Latinx) in Federally Qualified Health Centers (FQHCs). We compared outcomes to a demographically matched sample (n=245) from our prior delivery of the standard NDPP with pre-set goals for ≥150 minutes of physical activity per week and ≥5% weight loss. NDPP-Flex participants had similar attendance, physical activity, and weight loss, yet achieved about four times greater A1C improvement (0.22 ± 0.05% vs. 0.06 ± 0.03%; p=.018) and likelihood of normoglycemia at follow-up (OR 4.62; p=.013 [95% CI 1.38-15.50]). Clinically, these outcomes are highly significant as a 0.2% A1C reduction is associated with 58% lower risk of diabetes at 3 years, and a return to normoglycemia predicts 56% lower long-term incidence of diabetes. Our findings were published in Diabetes Care along with an invited commentary which noted that our approach is "innovative" and "should be adopted as part of our national strategy of health promotion."

We propose a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP to evaluate effects on glycemia, heterogeneity of treatment effects, and mechanisms of change. We will recruit 200 diverse adults with prediabetes (A1C 5.7-6.4%) and normal weight or overweight/obesity. Participants will enroll in classes (N=20) that are randomized to deliver NDPP-Flex or the standard NDPP. The trial is designed to have >95% power to detect anticipated treatment effects of ~0.2% A1C improvement and ~10% increase in participants who reach normoglycemia compared to the control arm. The study will be conducted by an expert team in a health system with the 8th largest network of FQHCs in the US (Denver Health) and in partnership with a premier research institution (University of Colorado). Specific aims are:

Aim 1. To assess effects of NDPP-Flex on A1C change (primary outcome) and achieving normoglycemia (A1C <5.7%) at 12-months (secondary outcome). Hypothesis: Compared to the standard NDPP, NDPP-Flex will reduce A1C and increase the likelihood of normoglycemia.

Aim 2. To assess heterogeneity of treatment effects on A1C by demographic characteristics (age, gender, race/ethnicity, income, language) and for individuals of normal weight (vs. overweight/obesity) to understand for whom NDPP-Flex may be effective. Hypothesis: For all subgroups of participants, NDPP-Flex will result in equivalent or superior A1C improvement than the standard NDPP.

Aim 3. To explore effects of NDPP-Flex on other health outcomes (weight, diet, physical activity) and psychosocial outcomes (motivation, perceived control, perceived stress). We will explore these outcomes as mediators of glycemic improvement to understand the key mechanisms of change. Hypothesis: NDPP-Flex will have a greater positive effect on psychosocial factors than the standard NDPP, which will account for greater A1C improvement than differences in health outcomes.

Impact: NDPP-Flex could shift clinical guidelines from prescriptive (and largely unattainable) goals to a more person-centered approach to diabetes prevention. Moreover, NDPP-Flex will be preferable from a health equity lens if it is better for underserved groups and without diminishing benefits for others. This approach could also expand public health impact by reaching lean adults with prediabetes who are currently excluded from the NDPP (given its focus on overweight/obesity), but account for ~10-20% of incident diabetes cases. The results have strong implementation potential through rapid dissemination among >2000 organizations that currently deliver the NDPP, and by contributing high-quality evidence to modernize clinical guidelines for prevention.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jayna DeRoeck; Phone Number: 3036022154; Email: Jayna.DeRoeck@dhha.org

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health
      • Contact: Jayna DeRoeck; Phone Number: 303-602-2154; Email: Jayna.DeRoeck@dhha.org
      • Principal Investigator: Natalie Ritchie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Established patient at Denver Health
• Age ≥18 years
• English- or Spanish-speaking
• Prediabetes (as defined by A1C of 5.7-6.4%)
• BMI ≥20 kg/m2 (≥18.5 kg/m2 if identifying as Asian)

Exclusion Criteria:

• Currently pregnant
• Prior participation in the NDPP
• Anti-hyperglycemic medication (e.g., metformin)
• Diabetes (type 1 or 2)
• BMI <20 kg/m2 (<18.5 kg/m2 if identifying as Asian)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: National Diabetes Prevention Program; The Diabetes Prevention Program was a successful clinical trial demonstrating that intensive lifestyle support for weight loss reduced diabetes incidence by 58%. The intervention was translated into the National Diabetes Prevention Program (NDPP) and disseminated by the Centers for Disease Control and Prevention as a yearlong group-based program since 2012.	Behavioral: NDPP; Usual care NDPP only
Experimental: NDPP-Flex; NDPP-Flex. The primary difference between NDPP-Flex and the standard NDPP is the approach to goal setting. In NDPP-Flex, coaches use the latest CDC-published curriculum, but adapted such that participants are encouraged to 1) set attainable, individually-tailored goals for risk-reduction, 2) adjust goals over time as needed, and 3) avoid all-or-nothing assessments of goal attainment. At each session, coaches provide a goal setting worksheet (see excerpt) with a simple, fillable format to better accommodate low literacy (e.g., "I will limit my soda and sugary drinks to __ per day").	Behavioral: NDPP-Flex; NDPP + patient-centered goal setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1C	Glycated hemoglobin	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
return to normoglycemia	A1C levels <5.7%	12 months

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: Natalie Ritchie, Denver Health

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 22-1695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified data resulting from ADA-funded research will be shared without compromising human subject protections to an approved open data repository. As appropriate for the research subject matter, data from the proposed study will be added to the PROMIS (Patient-Reported Outcomes Measurement Information System) repository. Recommended by NIH, PROMIS "is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions" (Source: http://www.healthmeasures.net/explore-measurement-systems/promis?tmpl=component). Making study data available on PROMIS is expected to support accessibility and expedient reuse of the data by a broad scientific community.
• IPD Sharing Time Frame: within 6 months of publication or 18 months of the award end date if the study remains unpublished; indefinite
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No