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Completed

NCT Number: NCT06445452

The Impact of SNAP-Ed 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).

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Key information

Conditions

Supplemental Nutrition Assistance Program Education Bhutanese Refugee Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Building Community in New Hampshire

Manchester, New Hampshire, 03101-1824, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of New Hampshire

Other

Registry information

Official study title

The Impact of SNAP-Ed on Dietary Quality, Food Safety Handling Behaviors, and Insulin Resistance Among Bhutanese Adults Residing in New Hampshire

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Jun 6, 2024
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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