Home-based Prediabetes Care in Acoma Pueblo - Study 1

NCT04029298 | Withdrawn

• 1 other identifier: 19-145-study 1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

PreDiabetes

Outcome Measures

Primary Outcomes (2)

• Change in BMI

  Change in BMI will be determined using a SECA 876 Floor Scale (SECA Inc., Chino, CA) for weight measurement, and height will be assessed using SECA 217 Portable Stadiometer with floor scale adapter. Height and weight will be reported as BMI in kg/m2, with a reference range of 18.5-24.9 kg/m2.

  Baseline, 4, 12 months (intervention group); Baseline, 12, 16, 28 months (control/delayed intervention group)

• Change in hemoglobin A1c

  To reproduce real-life community healthcare conditions, change in A1c will be assessed in both study groups with point-of-care measurement as an indicator of 90 day glucose homeostasis, with normal range of \<5.7%.

  Baseline, 4, 12 months (intervention group); Baseline, 12, 16, 28 months (control/delayed intervention group)

Secondary Outcomes (8)

• Type 2 diabetes incidence

  Baseline, 4, 12 months (intervention group); Baseline, 12, 16, 28 months (control/delayed intervention group)

• Waist-to-hip ratio

  Baseline, 4, 12 months (intervention group); Baseline, 12, 16, 28 months (control/delayed intervention group)

• Change in fasting blood glucose

  Baseline, 4, 12 months (intervention group); Baseline, 12, 16, 28 months (control/delayed intervention group)

• Change in blood pressure

  Baseline, 4, 12 months (intervention group); Baseline, 12, 16, 28 months (control/delayed intervention group)

• Change in fasting lipid panel

  Baseline, 4, 12 months (intervention group); Baseline, 12, 16, 28 months (control/delayed intervention group)

Study Arms (2)

HBDC Intervention Group

EXPERIMENTAL

Immediate enrollment in the 16-week, HBDC education-based intervention, followed by a 12-month observation period

Behavioral: Lifestyle Interventions

Control/Usual Care/Delayed Intervention Group

OTHER

16-week, HBDC education-based intervention will be delayed by 12 months. Following the delayed intervention, this group will be observed for an additional 12-month period

Behavioral: Lifestyle Interventions

Interventions

Lifestyle Interventions BEHAVIORAL

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

Control/Usual Care/Delayed Intervention Group; HBDC Intervention Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female Acoma tribal members aged 21-60 years who have:
• BMI ≥27 kg/m2 and/or a waist circumference \>90 cm for men or \>80 cm for women;
• A high risk of developing T2D as defined by an A1c between 5.7-6.4% and/or a baseline fasting glucose of 100-125 mg/dl;
• Willingness to consent to randomization

You may not qualify if:

• prior diagnosis of diabetes, excluding gestational diabetes;
• pregnant;
• No history of heart disease or advanced liver or kidney disease by participant report;
• diagnosis of terminal cancer in the last 5 years by report;
• taking medications that alter glucose homeostasis

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Pueblo of Acoma

Acoma Pueblo, New Mexico, 87034, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, CDE

Model Details: Prospective, randomized, controlled, non-blinded pilot study

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: March 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)