The Impact of SNAP-Ed Among Bhutanese Adults Residing in New Hampshire

NCT06445452 | Completed

• 1 other identifier: UNH-13-FY2022_38-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Supplemental Nutrition Assistance Program Education; Bhutanese Refugee Adults

Outcome Measures

Primary Outcomes (5)

• Healthy Eating Index Score

  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

  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

  Total cholesterol, LDL-Cholesterol, HDL-Cholesterol and triglycerides will be measured as an indicators of CVD risk.

  0 and 7-8 weeks

• Inflammatory Biomarkers

  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

  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

Study Arms (2)

SNAP-Ed

EXPERIMENTAL

Behavioral: Direct SNAP-Ed

No SNAP-Ed

PLACEBO COMPARATOR

Behavioral: Direct SNAP-Ed

Interventions

Direct SNAP-Ed BEHAVIORAL

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.

No SNAP-Ed; SNAP-Ed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of New Hampshire: lead

Study Sites (1)

Building Community in New Hampshire

Manchester, New Hampshire, 03101-1824, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: October 1, 2019
• Primary Completion: February 20, 2020
• Study Completion: September 30, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)