About this trial
The goal of this pilot study is to examine the feasibility of a novel meal kit and nutrition education intervention among adults aged 40 years and older, who are lower income, and to evaluate the preliminary impact of the meal kit and nutrition education intervention on food insecurity, dietary quality, mental health, quality of life and cardiovascular risk factors compared with general nutrition education materials in this population.
The main questions are:
What is the acceptability and satisfaction with the meal kits and nutrition education intervention?
What are the participation rates in the nutrition education program and the evaluation of the intervention?
What is the impact of the intervention on food insecurity, dietary quality and cooking and food preparation self-efficacy compared with general nutrition education materials?
What is the impact of the intervention of psychosocial health, quality of life and cardiometabolic outcomes compared with general nutrition education materials?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 40 years and older.
Household income at or less than the 200% the federal poverty level (household size 1: $30,120, household size 2: $40,880, household size 3: $51,640, household size 4: $62,400, and household size 5: $73,160)
Willing to provide informed consent and complete the study requirements, including attending study visits and completing questionnaires.
Access to a refrigerator or other means to safely store perishable food, as the meal kits require refrigeration.
Disqualifiers
Less than 40 years old
Does not have BMI >30 kg/m2, elevated blood pressure or hypertension, or elevated glucose, prediabetes or diabetes
Not able to provide consent (adults lacking capacity)
Follow a medically restricted diet or have allergies to wheat, soy, or dairy
Trial design
Parallel
Treatments tested in this trial
Meal Kit and Nutrition Education
Other interventionMeal kits contain ingredients for 3 meals designed for 4 servings, along with nutrition education materials, recipes, and information on how to store and prepare the meals. Weekly educational content focused on healthy eating, food security, and meal planning will be provided, either via print materials or through an online platform (e.g., email or app-based resources).
Treatment groups
Trial outcomes
Primary outcomes
Food insecurity
The U.S. Department of Agriculture (USDA) 10-item food security screener will be used. This tool asks participants about their food security within the last 12 months. Scores range from 0 to 10, which a score of 0 indicating high food security, 1-2 indicating marginal food security, 3-5 indicating low food security, and 6-10 indicating very low food security.
Dietary Quality
Dietary data will be collected by three 24-hr dietary recalls, using multi-pass interview software. At each time point, one 24-hour recall will be conducted during the interview, and two by phone within the following week (including a weekend day). A trained interviewer will use the Nutrition Data System for Research software (NDSR version 2019; Nutrition Coordinating Center, University of Minnesota).
Perceived Stress
Perceived Stress Scale: The 14- item Perceived Stress Scale (PSS) gauges the respondent's perception of stress over the last month. The PSS measures the extent to which respondents perceive their lives over the past month as unpredictable and uncontrollable. Total scores ranges from 0-56, with higher scores indicating greater perceived stress.
Anxiety
The State Trait Anxiety Scale assesses anxiety in participants using a 10-item questionnaire. Total scores range from 10 to 40, with greater scores indicating greater anxiety symptoms.
Sponsors and contacts
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