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NCT04755062 · ClinicalTrials.gov registry record · NA
A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans
A NA study of Obesity and Blood Glucose, High, sponsored by Northern Arizona University.
- Recruiting
- Registry status
- NA
- Development phase
- 146
- Enrollment target
- 1
- Study location
NCT04755062: Recruiting NA study of Obesity and Blood Glucose, High, sponsored by Northern Arizona University.
NCT04755062 is a NA study of Obesity and Blood Glucose, High that is actively recruiting participants, run by Northern Arizona University. The registered enrollment target is 146 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04755062, a NA study of Obesity and Blood Glucose, High, is actively recruiting participants, sponsored by Northern Arizona University.
- RECRUITING
- Registry status
- NA
- Development phase
- 146 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Micronutrient-dense plant-rich Intervention
Study Locations (1)
Arizona
- PRANDIAL Lab - Flagstaff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2025-06 |
| Phase | NA |
What NCT04755062 shows while recruiting
NCT04755062 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Micronutrient-dense plant-rich Intervention is the first listed.
NCT04755062 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT04755062 about?
NCT04755062 is a clinical study titled "A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans". 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 cont...
What is the current status of trial NCT04755062?
This trial is currently recruiting. It is a NA study. The enrollment target is 146 participants. The study started on 2023-01-18. Estimated completion is 2025-06.
What conditions does trial NCT04755062 study?
This clinical trial studies the following conditions: Obesity, Blood Glucose, High.
What interventions are being tested in trial NCT04755062?
The interventions under investigation include: Micronutrient-dense plant-rich Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04755062?
This trial is sponsored by Northern Arizona University, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04755062 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04755062's enrollment target sits among peer trials
146 392nd of 1053 higher than 659 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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