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Home-based Prediabetes Care in Acoma Pueblo - Study 1

NCT04029298 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-07-03

No results posted yet for this study

Summary

The prevalence of overweight, obesity and T2D among American Indians (AIs) in the Albuquerque service area of Indian Health Services (IHS) serving all pueblos in New Mexico including Pueblo of Acoma is disproportionately elevated. Specifically, among AI, adults age 18 and over in the IHS Albuquerque Service Area, 51% have a BMI \> 30, which significantly exceeds the rate of obesity observed nationally (35.3%) and the Healthy People 2020 target of 30.5%. Likewise, the rate of T2D (22.8%) among the adult AI population in our Albuquerque service area is almost double the rate of the U.S. adult population (12.2%), and the age-adjusted diabetes mortality rate for AIs was 104.7 per 100,000 compared to 23.1 per 100,000 among non-Hispanic Whites in the region. At the same time, the median age of diagnosis of T2D among AI adults was much younger (42.2 years) than the national average (53.8 years).

Our major goal of implementing educational interventions to slow the current rate of increase in diabetes in Native communities is aligned with NIH's (NIGMS) and NM INBRE's vision in reducing health disparity using innovative interventions. The investigators propose following aims:

Aim 1: Recruit and Screen 300 community members in Acoma Pueblo, NM to identify incident cases of pre-diabetes for the proposed study of Home Based Diabetes Care (HBDC);

Aim 2: Enroll 150 Acoma Natives aged 21-70 years, at risk for T2D (i.e., overweight, obese, and/or with at least one affected first degree relative or a history of gestational DM) and conduct HBDC for a 16-week lifestyle intervention in a longitudinal cohort study. Randomize household in a 1:1 allocation to enter either the intervention arm immediately or after a 12-month waiting list in control arm. Control participants will be treated with usual care. Participants randomized to the waiting list will enter the intervention group 12 months after entering the study. Both intervention groups will be followed longitudinally for total of 12 months.

Compared with people who will receive "usual care (control group)", prediabetic participants receiving 4 months of the HBDC will exhibit improved risk factor profiles for diabetes, obesity and heart disease, improved Patient Activation Measures, improved adherence with medical treatment, and improved Quality of Life scores.

Conditions

Interventions

BEHAVIORAL

Lifestyle Interventions

Educational based intervention to enhance lifestyle modifications such as diet, exercise, patient activation, and medication adherence

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04029298 on ClinicalTrials.gov