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

Primary Purpose

PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NDPP-Flex
NDPP
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Denver HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

National Diabetes Prevention Program

NDPP-Flex

Arm Description

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.

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").

Outcomes

Primary Outcome Measures

A1C
Glycated hemoglobin

Secondary Outcome Measures

return to normoglycemia
A1C levels <5.7%

Full Information

First Posted
September 26, 2022
Last Updated
May 1, 2023
Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05559515
Brief Title
Patient-centered Goal Setting in the National Diabetes Prevention Program
Acronym
NDPP-Flex
Official Title
Patient-centered Goal Setting in the National Diabetes Prevention Program: a Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
National Diabetes Prevention Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NDPP-Flex
Arm Type
Experimental
Arm Description
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").
Intervention Type
Behavioral
Intervention Name(s)
NDPP-Flex
Intervention Description
NDPP + patient-centered goal setting
Intervention Type
Behavioral
Intervention Name(s)
NDPP
Intervention Description
Usual care NDPP only
Primary Outcome Measure Information:
Title
A1C
Description
Glycated hemoglobin
Time Frame
12 months
Secondary Outcome Measure Information:
Title
return to normoglycemia
Description
A1C levels <5.7%
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayna DeRoeck
Phone
3036022154
Email
Jayna.DeRoeck@dhha.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Ritchie
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayna DeRoeck
Phone
303-602-2154
Email
Jayna.DeRoeck@dhha.org
First Name & Middle Initial & Last Name & Degree
Natalie Ritchie

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.healthmeasures.net

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Patient-centered Goal Setting in the National Diabetes Prevention Program

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