An interventional study of Interactive intervention group and Lecture-based intervention in Healthy, College Students and Diet Interventions, sponsored by Appalachian State University. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Appalachian State University · Not applicable, Interventional, and Prevention
The goal of this pilot randomized controlled trial (RCT) was to assess the feasibility, acceptability, and impacts of a whole-food plant-based (WFPB) vegan diet intervention for undergraduate university students randomly assigned, stratifying by sex and race/ethnicity, to one of two intervention groups (each with a distinct teaching-learning design, i.e., interactive (IA) versus lecture-based (LB)) and a control group. The main questions the researchers aimed to answer were:
The researchers compared the group outcome means for the two intervention groups against one another and those for the two intervention groups against those of the control group.
Study participants completed two sets of measurements over the course of 6 weeks.
This pilot randomized controlled trial (RCT), exploring the feasibility, acceptability, and impact of a whole-food plant-based (WFPB) vegan diet intervention on diet quality, WFPB vegan diet adherence, and health and intrapersonal factor outcomes for undergraduate students attending a southeastern public university, was theoretically informed by social cognitive theory and the theory of planned behavior. Specifically, key constructs from these two theories were measured via existing and researcher-created or adapted questionnaires. Also, these theories guided the design of the intervention session activities and approaches.
The primary aim of this 6-week pilot RCT was to assess the feasibility and acceptability of the study procedures for all participants and of the intervention sessions, experiential 21-day trial of a WFPB vegan diet, and prospect of continuing this dietary pattern for the intervention participants. The secondary aims included examining differential group mean changes between intervention and control groups in measures of diet quality, physical (e.g., lipids, glucose, weight) and mental (e.g., depressive symptoms, anxiety symptoms) health, and intrapersonal factors (e.g., self-efficacy, attitude toward behavior, perceived behavioral capability).
The researchers established inclusion and exclusion criteria to ensure fidelity of the study and safety of study participants. Institutional review board approval was obtained and recruitment involved emails and posting of fliers with information about the study aimed at reaching XX university students, department chairs, and faculty. Interested students first completed an eligibility survey, and, if eligible and interested in participating, proceeded to read the consent form, confirm their consent to participate by checking a box at the bottom of the form, and then continue with the online baseline survey. Upon completing the baseline survey, those still interested in participating scheduled in-person biometric measurement appointments. Ongoing consent was provided by presenting the consent form again prior to each study measurement.
After participants completed the baseline measurements, they were randomly assigned to one of three study groups. All three groups were asked to complete another set of measurements at the end of the study, i.e., another online survey and a second set of biometric measurements. The two intervention groups were additionally asked to engage in three consecutive weekly 75-minute educational "lunch and learn" sessions to gain knowledge about different aspects of the WFPB vegan diet between the two sets of survey and biometric measurements and were invited to participate in an end-of-study 1-hour audiorecorded focus group session (preceded by review of a written consent form that participants signed). The intervention groups were distinguished by the dominant approaches to and strategies for learning during their intervention sessions. One group, the interactive (IA) intervention group, primarily experienced group-based, active-learning activities during their sessions. The other group, lecture-based (LB) intervention group, learned through traditional lecture and completed activities individually. These two intervention group sessions were facilitated by different researchers in two separate nutrition lab spaces in the same building. The two intervention group sessions took place on the same days and times, lasted the same amount of time, and included the same content and WFPB vegan meals. It was hypothesized that the intervention groups would demonstrate greater improvements in diet quality and health and intrapersonal factor outcomes compared with the control group and, further, that the IA intervention group would exhibit more improvement on these outcomes as well as better adherence to and intention to continue following a WFPB vegan diet than the LB intervention group due to the inclusion of group-based learning and more engaging teaching and learning activities in the IA intervention sessions.
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This study's enrollment of 39 is below the median of 81 across 7,063 interventional studies indexed under Depression.
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Exclusion Criteria:
The control group participated in the following procedures: 1) completed online baseline and post-intervention surveys, and 2) completed in-person baseline and post-intervention biometric measurements. They did not receive any intervention in between these measurements. Of note, once the study concluded, a link to a website with information on the benefits of whole-food plant-based (WFPB) vegan diets and resources helpful to trying out and following this diet was provided to these participants.
This interactive intervention (IA) group participated in whole-food plant-based (WFPB) vegan educational sessions emphasizing group-based and individual active-learning strategies.
Other: Interactive intervention group
This lecture-based (LB) intervention group participated in whole-food plant-based (WFPB) vegan educational sessions emphasizing traditional lecture-based learning and time for individual work and reflection.
Other: Lecture-based intervention
This interactive intervention (IA) group participated in the following procedures: 1) completed online baseline and post-intervention surveys, 2) completed in-person baseline and post-intervention biometric measurements, and 3) attended one or more of three consecutive weekly 75-minute lunch and learn sessions, whole-food plant-based (WFPB) vegan educational sessions emphasizing group-based and individual active-learning strategies, e.g., meal-planning, goal-setting, goal-achievement reflection, and experiential learning. They also were given a link to a website with WFPB vegan resources and were invited and voluntarily participated in a 1-hour end-of-study focus group.
Also known as: IA group
This lecture-based intervention (LB) group participated in the following procedures: 1) completed online baseline and post-intervention surveys, 2) completed in-person baseline and post-intervention biometric measurements, 3) attended one or more of three consecutive weekly 75-minute lunch and learn sessions, emphasizing traditional lecture-based learning and time for individual work and reflection, e.g., on meal-planning, goal-setting, goal-achievement reflection, as well as experiential learning. They also were given a link to a website with WFPB vegan resources and were invited and voluntarily participated in a 1-hour end-of-study focus group.
Also known as: LB group
Feasibility and Acceptability: Study Uptake
Feasibility and acceptability of the study design, i.e., study procedures, measurements, and intervention components, were measured via study uptake rate. Study uptake was defined as enrolling in the study, completing a baseline online survey, and completing a baseline measurement session. Higher study uptake reflected greater feasibility and acceptability of the study design.
Time frame: From enrollment through the first 10 days of the study, i.e., the last day to have enrolled, completed an online baseline survey, and completed a baseline biometric measurement session
Feasibility and Acceptability: Study Attrition
Study attrition was computed based on non-completion of one or more of the measurements and, in the case of intervention participants, not attending any of the intervention sessions. Lower study attrition reflected greater feasibility and acceptability.
Time frame: From enrollment to the end of the study at 6 weeks
Feasibility and Acceptability: Intervention Engagement
The researchers examined intervention engagement by taking attendance at the interactive and lecture-based intervention sessions and calculated rates of attendance of 1, 2, or 3 sessions. Attendance of at least one session was counted as receiving the intervention, i.e., engagement. Higher attendance supported better feasibility and acceptability of the intervention sessions.
Time frame: Weeks 3 through 5 of the study
Feasibility and Acceptability: Qualitative Assessment
Feasibility and acceptability of the study design, i.e., study measurement procedures, intervention sessions, and of following a whole-food plant-based vegan diet, were measured qualitatively via a semi-structured focus group session with a non-random subset of interactive (IA) and lecture-based (LB) intervention participants. More positive than negative comments and feedback supported greater feasibility and acceptability.
Time frame: At the end of the study, during week 6
Feasibility and Acceptability: Food Acceptability Questionnaire
Feasibility and acceptability of following a whole-food plant-based vegan diet was measured via responses to the 12-item Food Acceptability Questionnaire as part of the post-intervention online survey. This questionnaire only provides descriptive data. There is no validated scoring procedure or cut-off for high versus low acceptability. Therefore, the findings were assessed descriptively, i.e., with frequencies.
Time frame: At the end of the study, during week 6
Predicted Dietary Intakes: Dietary Screener Questionnaire
Diet quality was assessed using predicted dietary intakes calculated via the 26-item Dietary Screener Questionnaire (DSQ). This screener asks about the frequency of consumption in the past month of selected foods and drinks. The DSQ captures intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat. Responses are on 9-point (for food items) and 11-point (for beverages) Likert scales, ranging from "never" to "two or more times/day" and "never" to "six or more times/day," respectively. Regression- and logistic-based scoring algorithms are used to convert self-reported food frequency data into quantitative daily intake estimates and prevalence probabilities. For this study, intakes more aligned with the 2015 Dietary Guidelines for Americans reflected better diet quality. The researchers assessed differential change in mean predicted intakes descriptively and via effect sizes across the study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Diet Quality Changes: Plant-Based Natural and Animal-Based Processed Scores
Diet quality was assessed via calculation of plant-based natural (PBN) and animal-based/processed (ABP) scores. The researchers assigned scores of 1 to 4 to quartiles of cup intakes of vegetables and fruits and ounce equivalents of whole grains (different cup and ounce equivalent thresholds by sex) to calculate the PBN scores. The PBN scores ranged from 3 to 12. The researchers assigned scores of 1 to 4 to different frequencies of intakes of dairy products and red and processed meats and quartiles of teaspoon per day intakes of added sugars to calculate ABP scores; ABP scores ranged from 5 to 20. Dairy product and red and processed meat frequency thresholds were the same by sex, and added sugar amounts differed by sex. Higher PBN and lower ABP scores suggested better overall diet quality. There are no validated cut-off scores for either. The researchers assessed differential change in group mean PBN and ABP scores descriptively and via effect sizes across the study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Dietary Adherence: Plant-Based Natural and Animal-Based Processed Scores
Adherence to a whole-food plant-based (WFPB) vegan diet was assessed via calculation of plant-based natural (PBN) and animal-based/processed (ABP) scores. Scores of 1 to 4 were assigned to quartiles of cup intakes of vegetables and fruits and ounce equivalents of whole grains (different cup and ounce equivalent thresholds by sex) to calculate the PBN scores. The PBN scores ranged from 3 to 12. Scores of 1 to 4 were assigned to different frequencies of intakes of dairy products and red and processed meats and quartiles of teaspoon per day intakes of added sugars to calculate ABP scores. ABP scores ranged from 5 to 20. Dairy product and red and processed meat frequency thresholds were the same by sex, and added sugar amounts differed by sex. Higher PBN and lower ABP scores suggested better adherence to the diet. There are no validated cut-off scores. The researchers assessed differential change in group mean PBN and ABP scores descriptively and via effect sizes across study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Weight Changes
The researchers measured weight in kilograms using a digital scale. Weight alone was not interpreted as high or low; rather, the researchers assessed differential change (gain or loss) in group mean weight descriptively and via effect sizes across the study groups. This measure was also used to calculate body mass index.
Time frame: From enrollment to the end of the study at 6 weeks
Body Mass Index Changes
The researchers measured height in centimeters using a stadiometer at baseline only. The researchers entered this height measurement together with the weight in kilograms into a body mass index (BMI) calculator to calculate and report BMI in kilograms/meter\^2. The researchers assessed differential change in group mean BMI descriptively and via effect sizes across the study groups. The reference ranges used to interpret group mean BMIs were as follows: BMI \< 18.5 = underweight; 18.5 to 24.9 = healthy weight; 25.0 to 29.9 = overweight; 30 or above = obesity.
Time frame: From enrollment to the end of the study at 6 weeks
Waist Circumference Changes
The researchers used a flexible tape measure to assess waist circumference in centimeters. The researchers assessed differential change in group mean waist circumference descriptively and via effect sizes across the study groups. The researchers used standard western population cut-offs, i.e., for males, a measurement greater than or equal to 102 cm, and for females, a measurement greater than or equal to 88 cm, for high versus low waist circumference.
Time frame: From enrollment to the end of the study at 6 weeks
Blood Pressure Changes
The researchers used a stethoscope and manual sphygmomanometer to measure systolic and diastolic blood pressure in millimeters of mercury (mmHG). The researchers assessed and reported differential change in group mean systolic and group mean diastolic blood pressure descriptively and via effect sizes across the study groups. Greater than or equal to 130 systolic and 80 diastolic = hypertension; 130-139 systolic/ 80-89 diastolic = stage 1 hypertension; greater than or equal to 140 systolic/ 90 diastolic = stage 2 hypertension.
Time frame: From enrollment to the end of the study at 6 weeks
Lipid Profile Changes
The researchers assessed lipids using the Cholestech LDX® glucose and lipid analyzer. The researchers collected 40 micrograms of capillary blood to assess and report total cholesterol (TC), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL) and tryglicerides (TG). The researchers calculated non-HDL cholesterol by subtracting HDL from TC. They reported these results in milligrams per deciliter and assessed and reported differential change in group mean TC, HDL, LDL, and non-HDL cholesterol and TG descriptively and via effect sizes across the study groups. Optimal lipid levels: TC equal to or less than 150 mg/dL; LDL equal to or less than 100 mg/dL; HDL at least 40 mg/dL in males and 50 mg/dL in females; TG less than 150 mg/dL; non-HDL less than 130 mg/dL.
Time frame: From enrollment to the end of the study at 6 weeks
Glucose Changes
The researchers assessed fasting glucose using the Cholestech LDX® glucose and lipid analyzer. The researchers collected 40 micrograms of capillary blood to assess glucose and reported the results in milligrams per deciliter. They assessed and reported differential change in group mean glucose descriptively and via effect sizes across the study groups. Normal fasting glucose = 99 mg/dL or less; Prediabetes = 100-125 mg/dL; Diabetes = 126 mg/dL or above.
Time frame: From enrollment to the end of the study at 6 weeks
Depressive Symptoms Changes: Center for Epidemiological Studies Depression Scale Revised
The researchers used the 10-item Center for Epidemiological Studies Depression Scale Revised (CESD-R-10) to measure depressive symptom scores. They assessed and reported differential change in group mean depressive symptom scores descriptively and via effect sizes across the study groups. The possible range of scores is 0-30 with higher scores representing greater degrees of depressed mood. The cut-off score for higher risk for clinical depression is greater than or equal to 10.
Time frame: From enrollment to the end of the study at 6 weeks
Anxiety Symptoms Changes: Generalized Anxiety Disorder Tool
The researchers used the 7-item Generalized Anxiety Disorder (GAD-7) tool to measure anxiety symptom scores. They assessed and reported differential change in group mean anxiety symptom scores descriptively and via effect sizes across the study groups. The possible range of scores is 0-21. Scores from 0-4 = minimal anxiety; 5-9: mild anxiety; 10-14 moderate anxiety; 15-21 severe anxiety. A score of 10 or greater is the cut-off for generalized anxiety disorder with need for further assessment.
Time frame: From enrollment to the end of the study at 6 weeks
Eating Self-Efficacy Score Changes: Eating Self-Efficacy Brief Scale
The researchers measured eating self-efficacy using an adaptation of the 8-item Eating Self-Efficacy Brief Scale. Scores were calculated by summing the scale responses; higher scores reflected higher eating self-efficacy. The range of scores is 8 to 48. There is not validated cut-off score. The researchers modified the stem used in this scale from 'Below is a list of situations in which people may have difficulties in resisting the urge to eat. For each situation, please answer considering how easy it would be to resist the urge to eat' to 'On a scale of 1 to 6 (1= extremely hard to 6= extremely easy), how would it be to follow a whole-food plant-based diet?' They assessed and reported differential change in group mean eating self-efficacy scores descriptively and via effect sizes across the study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Outcome Expectation Score Changes: Outcome Beliefs Scale
The researchers measured outcome expectations using a 10-item translated and adapted Outcome Beliefs Scale. The researchers altered the stem for this scale from 'If eating at least two pieces of fruit and 200 grams of vegetables a day…' to read, 'If eating a whole-food plant-based diet…' and removed the "neutral" response, resulting in a 6-point Likert scale (1= strongly disagree to 6= strongly agree). Scores were calculated by summing the responses; higher scores reflected more positive outcome beliefs. The range of scores was 10 to 60. There is no validated cut-off score. The researchers assessed and reported differential change in group mean eating outcome belief scores descriptively and via effect sizes across the study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Attitude Toward Behavior Score Changes: Attitude Toward Behavior Measure
The researchers measured attitude toward eating a whole-food plant-based (WFPB) vegan diet via the 4-item attitude toward behavior (ATB) measure. Originally created to assess this construct in relation to meat-eating, vegetarian, and vegan diets, for this study, the ATB measure was asked only with regard to a WFPB vegan diet. The ATB measure asks participants to rate on a 7-point Likert scale their attitudes towards a diet, i.e. 1= very bad to 7= very good, 1= very harmful to 7= very beneficial, 1= very unpleasant to 7= very pleasant, and 1=very unenjoyable to 7= very enjoyable. Scores were calculated by summing the responses; higher scores reflected more positive ATB. The scores ranged from 4 to 28. There is no validated cut-off score. The researchers assessed and reported differential change in group mean ATB scores descriptively and via effect sizes across the study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Perceived Behavioral Control Score Changes: Perceived Behavioral Control Measure
The researchers measured perceived behavioral control (PBC) with following a whole-food plant-based (WFPB) vegan diet with the 3-item perceived behavioral control measure. Originally created to assess PBC in relation to meat-eating, vegetarian, and vegan diets, for this study, this measure was asked with regard only to the WFPB vegan diet. The PBC measure inquired, using a 7-point Likert scale, about personal control (1= no control to 7= complete control), capability (1= very incapable to 7= very capable), and difficulty (1= very difficult to 7= very easy) with following a WFPB vegan diet in the future. Scores were calculated by summing the responses; higher scores reflected higher PBC. The scores ranged from 3 to 21. There is no validated cut-off score. The researchers assessed and reported differential change in group mean PBC scores descriptively and via effect sizes across the study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Behavioral Intention Score Changes: Behavioral Intention Measure
The researchers measured behavioral intention (BI) to continue following a whole-food plant-based (WFBP) vegan diet in the future with the 1-item behavioral intention measure. Originally created to assess BI in relation to meat-eating, vegetarian, and vegan diets, for this study, participants were asked to rate their agreement with a single statement about intending to eat a WFPB vegan diet in the future on a 6-point Likert scale (removed the "neutral" response on the original measure) from 1= strongly disagree to 6= strongly agree. Scores ranged from 1 to 6. There is no validated cut-off score. The researchers assessed and reported differential change descriptively and via effect sizes in group mean BI scores across the study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Behavioral Capability Score Changes: Food and Cooking Skills Confidence Measure
Behavioral capability (BC) was measured using the confidence measure from the Food and Cooking Skills tool, consisting of 19-items divided into 5 different domains: meal planning and preparing, shopping, budgeting, resourcefulness, and label reading/consumer awareness. The researchers dropped 3 items due to their lack of relevance (e.g., buying cheaper cuts of meat to save money, using best-before dates, and storage use-by information). Participants were asked to rate on a 7-point Likert scale how good they were at particular food/cooking skills: 1=very poor and 7=very good and 0=never/rarely do the skill. The confidence score was derived by summing the 1 to 7 ratings for the skills used. Thus, the range in scores was 1 to 112, with higher scores indicating greater confidence. There is no validated cut-off score. Differential change in group mean BC scores across the study groups was reported descriptively and via effect sizes.
Time frame: From enrollment to the end of the study at 6 weeks
Self-Regulation of Eating Behavior: Self-Regulation of Eating Behaviour Questionnaire
The researchers measured self-regulation of eating behavior (SREB) using an adaptation of the 5-item Self-Regulation of Eating Behaviour Questionnaire (SREBQ). Three screening questions about intentions to eat a healthy diet or avoid tempting foods precede the questionnaire. The researchers dropped these three screening questions and used one prompt that asked participants to rate on a 5-point Likert scale the frequency with which statements about eating intentions were true for them, 1=never to 5=always (3 statements with reverse scoring). The scale is scored by calculating the means of the responses, ranging from 1 to 5; a mean \< 2.8 suggests low self-regulation, 2.8 to 3.6 medium self-regulation, and \> 3.6 high self-regulation. The researchers assessed and reported differential change in group mean SREBQ scores descriptively and via effect sizes across the study groups.
Time frame: From enrollment to the end of the study at 6 weeks
Plan to share: No
Ran from Mar 2023 to primary completion in May 2023, 1 month.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 1 month is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
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Appalachian State University