Supplemental Nutrition Assistance Program EducationNCT06445452
The Impact of SNAP-Ed Among Bhutanese Adults Residing in New Hampshire
A study testing Direct SNAP-Ed in people with Supplemental Nutrition Assistance Program Education and Bhutanese Refugee Adults, run by University of New Hampshire at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Supplemental Nutrition Assistance Program Education, Bhutanese Refugee Adults
- What is being tested?
- Direct SNAP-Ed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Building Community in New Hampshire
Manchester, New Hampshire, 03101-1824
About this study
Official title: 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).
- Being tested
- Direct SNAP-Ed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct SNAP-EdBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SNAP-Ed | Experimental | Not described Receives: Behavioral: Direct SNAP-Ed |
| No SNAP-Ed | Placebo comparator | Not described Receives: Behavioral: Direct SNAP-Ed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 0 and 7-8 weeks
Inflammatory Biomarkers
TNF-alpha, C-Reactive Protein, and IL-6 will be measured where higher values indicate greater inflammation.
Measured: 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.
Measured: 0 and 7-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Oct 2019
- Primary completion20 Feb 2020
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supplemental Nutrition Assistance Program EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherman Bigornia, University of New Hampshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445452
- Sponsor's protocol ID
- UNH-13-FY2022_38-01
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of SNAP-Ed on Dietary Quality, Food Safety Handling Behaviors, and Insulin Resistance Among Bhutanese Adults Residing in New Hampshire
- ClinicalTrials.gov ID
- NCT06445452
- Acronym / sponsor ID
- UNH-13-FY2022_38-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNAP-Ed | Experimental | Behavioral: Direct SNAP-Ed |
| No SNAP-Ed | Placebo comparator | Behavioral: Direct SNAP-Ed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct SNAP-EdSix 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. | Behavioural | No SNAP-Ed, SNAP-Ed |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct SNAP-Ed in people with Supplemental Nutrition Assistance Program Education and Bhutanese Refugee Adults, run by University of New Hampshire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Eating Index Score (time frame: 0 and 7-8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.