RightFit
RecruitingNot applicable

Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center

One-arm Feasibility and Acceptability Pilot Study of a Community-informed Nutrition Intervention to Recruit, Engage, and Retain Patients Who Are Eligible to Participate in the Diabetes Prevention Program at Two Community Health Centers in Los Angeles

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study team will also conduct weekly check-ins with the participants during this period to collect surveys to measure satisfaction, nutritional knowledge, consumption of fruits and vegetables, and healthy eating habits."
  • "Castellon-Lopez and the study team will use standard surveys and open-ended questions to ensure that we capture the full range of perspectives from all the participants weekly and at the end of the 7-week intervention period, we will conduct audio-recorded interviews with the study participants."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether hands-on lessons about healthy eating can fit into the Diabetes Prevention Program and whether patients find them helpful and acceptable. It is for adults at a community health center who have prediabetes or are at risk for it.

The purpose of the study is to assess the feasibility and acceptability of incorporating hands-on nutritional demonstrations to enhance the Diabetes Prevention Program (DPP) curriculum among patients who are at-risk for prediabetes

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Body mass index (BMI), a measure of weight compared with height, of 25 or higher, or 23 or higher if Asian.
  • Blood sugar tests showing prediabetes, such as fasting blood sugar of 110–125 mg/dL or A1C of 5.7–6.4%. A1C measures average blood sugar over about 3 months.
  • No diagnosis of type 1 or type 2 diabetes.
  • Moderate to high risk of prediabetes, or a prediabetes diagnosis from a medical provider in the past 12 months. Prediabetes means blood sugar is above normal but below the diabetes range.
  • Able to join or already enrolled in the Diabetes Prevention Program.

Who can't join

  • Younger than 18.
  • The BMI exclusion rule is unclear as written. The entry rule requires a BMI of at least 25, or at least 23 if Asian.
  • Blood sugar tests do not meet the study's rules for prediabetes.
  • Currently diagnosed with type 1 or type 2 diabetes.
  • No medical provider finding of moderate to high risk for prediabetes or diagnosis of prediabetes in the past 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 18+ years old * BMI of 25 or higher (23 or higher if Asian) * Meet specific blood sugar test criteria indicating prediabetes, such as a fasting plasma glucose level between 110-125 mg/dL or an A1C level between 5.7-6.4% * Not be diagnosed with type 1 or type 2 diabetes * Moderate to high risk of having prediabetes or a known diagnosis of prediabetes by their medical provider in the last 12 months. * Eligible or enrolled in the Diabetes Prevention Program Exclusion Criteria: * Younger than 18 years of age * BMI of less than 25 or higher (or under 23 if Asian) * Does not meet specific blood sugar test criteria indicating prediabetes, such as a fasting plasma glucose level between 110-125 mg/dL or an A1C level between 5.7-6.4% * Currently diagnosed with type 1 or type 2 diabetes * Has not been diagnosed as moderate to high risk of having prediabetes or having a known diagnosis of prediabetes by their medical provider in the last 12 months.

Study sites (1)

CA