Pulse Education and Children

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT07648446
Status
Recruiting

Conditions

  • Cardiometabolic Health Indicators
  • Dysbiosis
  • Education on Feeding and Health Status
  • Gut Motility

Eligibility Criteria

Sex
ALL
Age
6 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

  • Education Only — OTHER
    Participants receive six weekly pulse-focused nutrition sessions via printed handouts, PPTs, and recipe cards covering pulse nutrition, health benefits, and cooking methods. Families prepare three pulse-based meals per week following a stepwise intake schedule (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6) and purchase pulses independently. One of four pulses (lentils, chickpeas, black eye peas, black beans) will be assigned each week.
  • Education + Pulse Provision — OTHER
    Participants will receive the same six-week pulse education program as the EO group. To further improve success, EP will include individualized dietitian counseling alongside written educational materials, a common strategy in dietary education interventions. In addition to education, EP families will receive free weekly supply of pulses, pre-measured and packaged according to the same stepwise intake plan. The pulses provided will include chickpeas, lentils, and black beans, owing to their prebiotic and gut health benefits as identified in previous research. Families prepare three pulse-based meals per week and complete the same adherence tracking as the EO group. Pulse provisions are scaled to household size to ensure all members meet intake goals.
  • Cooking Class — OTHER
    The cooking class component will consist of a 4-week family-based cooking series involving both parent(s) and child(ren), with each week focused on a specific pulse: Week 1 (black beans), Week 2 (lentils), Week 3 (black-eyed peas), and Week 4 (chickpeas). Participants will be expected to prepare at least three meals per week using the designated pulse, for a total intake of approximately 1.5 cups per week. On days when pulses are consumed, participants will complete a Pulse Meal Record using a 24-hour dietary recall format to document intake, preparation method, and portion size. Children will also complete a Child Food Experience Survey after each pulse-containing meal; for children aged 6-8 years, parents may read the survey questions aloud as needed. Cooking classes will be administered in separate blocks to ensure that EO and EP participants attend distinct sessions. EO participants will independently review the assigned educational materials before each class. EP participants wi

Study Details

This parallel-arm, randomized controlled trial will evaluate the effectiveness of a 6-week pulse-focused nutrition intervention in school-aged children (6-13 years). The study aims to assess adherence to a pulse-based diet providing 1.5 cups of pulses per week and to examine the effects of whole-cooked pulse consumption on gut health, including gut microbiome composition, metabolomic profiles, and gut barrier function. Secondary objectives include evaluating the impact of pulse consumption on markers of metabolic health and inflammation. Forty participants will be randomized to either a pulse-focused nutrition education program with weekly provision of pre-measured pulses (black beans, lentils, and chickpeas) or a pulse-focused nutrition education program in which participants independently procure their own pulses. Participants will follow the assigned intervention for 6 weeks.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Education + Pulse Provision Condition
    Participants will a six-week pulse education program similar to the education-only group. However, this group will include individualized dietitian counseling alongside written educational materials, a common strategy in dietary education interventions. In addition to education, families will receive free weekly supply of pulses, pre-measured and packaged according to a stepwise intake plan (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6). The pulses provided will include chickpeas, lentils, and black beans, owing to their prebiotic and gut health benefits as identified in previous research. Families will be asked to prepare three pulse-based meals per week and complete adherence tracking. Pulse provisions are scaled to household size to ensure all members meet intake goals.
  • Active Comparator: Education Only Condition
    Participants will receive six weekly pulse-focused nutrition sessions via printed handouts, PPTs, and recipe cards covering pulse nutrition, health benefits, and cooking methods. Families will be asked to prepare three pulse-based meals per week following a stepwise intake schedule (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6) and purchase pulses independently. Adherence is tracked through weekly food logs, checklists, and surveys on child acceptance, meal satisfaction, and preparation feasibility.

Primary Outcome Measure

Adherence to Pulse Intake [ Time Frame: Baseline to Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Gut Biome LabTallahasseeFlorida32306
Ravinder Nagpal, PhD
850-644-1829
Rayven Nairn, MS, RD (SUB_INVESTIGATOR)

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