Obesity Clinical Trial
Official title:
Reduction of Risk Factors for Obesity and Linked Chronic Diseases in Native American Employees of the Twin Arrows Casino Through a Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention
The investigators propose to conduct a randomized controlled trial with a wait-list control to determine efficacy in reducing risk of obesity and related disease in Native American employees of Twin Arrows Casino. Participants will be randomly assigned to the experimental group or the wait-list control. The experimental group will receive a 12-week mNDPR nutrition intervention with culturally relevant materials. Five NAU Masters of Public Health (MPH) students will be trained in Motivational Interviewing and the mNDPR nutrition protocol to serve as Lifestyle Coaches. These students will lead weekly, group-based coaching sessions with up to 15 participants each at Twin Arrows Casino. Participants will be assigned to their designated group based on their availability. The 12 weekly group sessions will be scheduled to accommodate various work shifts (day, night, and swing). The first group session will be 2-hours long to serve as an 'immersion', followed by weekly 1-hour sessions, all led by the Lifestyle Coaches. The Lifestyle Coaches will use Motivational Interviewing techniques to assist participants to develop personal goals. Lifestyle Coaches will also provide nutrition education, specifically using the mNDPR protocol. Participants in the wait-list control will receive the same intervention after the experimental group completes their 12-week intervention. In addition to measures at weeks 0 and 13, a 24-hour diet recall will be conducted in week 26 for the experimental group to explore long-term durability of diet quality changes.
Status | Recruiting |
Enrollment | 146 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Self-identified Native American employee of Twin Arrows Casino; - 21-65 years of age; - self-reported body mass index (BMI) of >24 kg/m; - not currently participating in a weight-loss program; - not taking any medications that could increase medical risk (e.g., insulin) or that had weight loss as a primary side effect; - must work at Navajo Gaming Enterprise one year prior to the start of the study and indicate intent to work at Navajo Gaming Enterprise over the following year through the length of the study. Exclusion Criteria: - Individuals reporting gastric bypass, adjustable gastric band, gastric sleeve, or duodenal switch weight loss surgeries; - pregnancy, or planning to become pregnant within the next year; - insulin dependence; - inability to attend weekly group coaching sessions will be ineligible to participate. |
Country | Name | City | State |
---|---|---|---|
United States | PRANDIAL Lab | Flagstaff | Arizona |
Lead Sponsor | Collaborator |
---|---|
Northern Arizona University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline weight at week 13 and week 26 | Weight will be measured in duplicate using a SECA 813 digital scale, with measurement from 0-440lb (200kg), with higher numbers representing higher weight (worse outcome) | 26 weeks | |
Other | Height | Height will be measured in duplicate using a stadiometer. | Week 0 | |
Other | Change from baseline diet at week 13 and week 26 | The ASA 24-hour dietary assessment tool will be used to measure diet. This is not a single scale, rather the data determine multiple dietary variables including fruit and vegetables, whole grains, and dietary fats. | 26 weeks | |
Primary | Change from baseline Hemoglobin A1c (HgA1c) at week 13 and week 26 | Analysis of plasma from fasting venous blood draws using one of the following methods: 1) HPLC, Cation-exchange HPLC, Boronate affinity chromatography, Capillary electrophoresis, Immunoassays, or Enzymatic methods. | 26 weeks | |
Secondary | Change from baseline Fasting Glucose at week 13 and week 26 | Analysis of plasma from fasting venous blood draws using standardized enzymatic methods. | 26 weeks | |
Secondary | Change from baseline Fasting Insulin at week 13 and week 26 | Analysis of serum from fasting venous blood draws using insulin radioimmunoassay methods. | 26 weeks | |
Secondary | Change from baseline Blood lipids at week 13 and week 26 | Analysis of plasma from fasting venous blood draws using standardized, automated, high throughput, enzymatic analyses. | 26 weeks | |
Secondary | Change from baseline High sensitivity C-reactive protein (hsCRP) at week 13 and week 26 | Analysis of plasma from fasting venous blood draws using ELISA, immunoturbidimetry, time-resolved immunofluorimetric assay, or mass spectometry. | 26 weeks | |
Secondary | Change from baseline Insulin-like Growth Factor (IgF-1) at week 13 and week 26 | Analysis of plasma from fasting venous blood draws using immunoassay, mass spectrometry, liquid chromatography tandem mass spectometry, or liquid chromatography high resolution accurate-mass mass spectrometry. | 26 weeks | |
Secondary | Change from baseline systolic and diastolic blood pressure at week 13 and week 26 | Auscultation method will be used to determine Korotkoff sounds over multiple blood pressure readings that will be averaged at each assessment. At each measurement point (weeks 0, 13, and 26), measurement staff will take blood pressure four times, twice on the first day of testing and twice on the second day. | 26 weeks |
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