- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06445452
The Impact of SNAP-Ed Among Bhutanese Adults Residing in New Hampshire
May 31, 2024 updated by: Sherman Bigornia, University of New Hampshire
The Impact of SNAP-Ed on Dietary Quality, Food Safety Handling Behaviors, and Insulin Resistance Among Bhutanese Adults Residing in New Hampshire
The goal of this pilot randomized controlled trial is to test the potential efficacy of Supplemental Nutrition Assistance Program Education (SNAP-Ed) among Bhutanese refugee adults residing in New Hampshire.
The main questions are whether direct SNAP-Ed delivered through 6 lessons affects dietary quality and biomarkers of metabolic risk.
Participants in the SNAP-Ed arm will be asked to participate in weekly lessons delivered in their homes by a bicultural and bilingual nutrition educator.
Individuals in the control group did not receive SNAP-ED.
All participants will be asked to complete surveys and provide blood and fecal samples prior at baseline and at the end of the study period (7 to 8 weeks).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Manchester, New Hampshire, United States, 03101-1824
- Building Community in New Hampshire
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria are (1) identifies as a Bhutanese refugee (2) 18 years and older (3) does most of the cooking and shopping for his/her household.
Exclusion Criteria are (1) has been told by her/his doctor that she/he has diabetes (2) history of use of glucose lowering medications (3) pregnant or trying to become pregnant (4) currently diets for weight loss or dietary restrictions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SNAP-Ed
|
Six in-home SNAP-Ed lessons are delivered to participants in the SNAP-Ed arm.
Lessons are offered weekly and directed by a bilingual and bicultural community health worker.
|
|
Placebo Comparator: No SNAP-Ed
|
Six in-home SNAP-Ed lessons are delivered to participants in the SNAP-Ed arm.
Lessons are offered weekly and directed by a bilingual and bicultural community health worker.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy Eating Index Score
Time Frame: 0 and 7-8 weeks
|
All participants will provide three 24-hr recalls at baseline and the exit visit.
Dietary intake will be average across the three recalls.
The HEI score rubric will be applied to the dietary intakes where a higher score indicates greater adherence to the US Dietary Guidelines.
|
0 and 7-8 weeks
|
|
Glucose Homeostasis Biomarkers
Time Frame: 0 and 7-8 weeks
|
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) is calculated using fasting insulin and glucose values, where a higher values indicates greater insulin resistance.
HbA1c will also be measured.
|
0 and 7-8 weeks
|
|
Lipid Panel
Time Frame: 0 and 7-8 weeks
|
Total cholesterol, LDL-Cholesterol, HDL-Cholesterol and triglycerides will be measured as an indicators of CVD risk.
|
0 and 7-8 weeks
|
|
Inflammatory Biomarkers
Time Frame: 0 and 7-8 weeks
|
TNF-alpha, C-Reactive Protein, and IL-6 will be measured where higher values indicate greater inflammation.
|
0 and 7-8 weeks
|
|
Gut Microbiome Composition
Time Frame: 0 and 7-8 weeks
|
Outcomes include short-chain fatty acids (Akkermansia municiphilla, Ruminococcus bromii, Faecalibacterium prausnitzii, Eubacterium rectale, and Eubacterium hallii) and lower abundance of those that synthesize branched-chain amino acids (Bacillus-Lactobacillus-Streptococcus groups, and Proteobacteria).
In addition, gut microbial diversity will be assessed.
|
0 and 7-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
February 20, 2020
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
May 31, 2024
First Submitted That Met QC Criteria
May 31, 2024
First Posted (Actual)
June 6, 2024
Study Record Updates
Last Update Posted (Actual)
June 6, 2024
Last Update Submitted That Met QC Criteria
May 31, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- UNH-13-FY2022_38-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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