The Dietary Guidelines 3 Diets Study (NCT04981847) | Clinical Trial Compass
CompletedNot Applicable
The Dietary Guidelines 3 Diets Study
United States63 participantsStarted 2021-08-01
Plain-language summary
The goal of this project is to use a two-stepped study to examine both the adoption of the three dietary patterns as presented by the United States Dietary Guidelines (USDG) and testing of a refined, culturally tailored one-year intervention examining the three diet patterns. For this study, African American adult participants with overweight/obesity and ≥three type 2 diabetes (T2DM) risk factors will be recruited to participate in this two-step study. This present study is for our Step 1: formative pilot work to culturally-tailor a dietary intervention of the three healthy eating patterns presented by the USDG for 12 weeks: 1) U.S.-Style, 2) Mediterranean, or 3) Vegetarian.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-65 years of age
* BMI between 25- 49.9 kg/m2
* self-identify as African American
* live in the Columbia, SC area
* be able to attend all monitoring visits
* be willing to be randomized to either condition and be re-randomized if non-responsive
* be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
Exclusion Criteria:
* should not be pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 24 months, or currently breastfeeding
o Women who are pregnant should not be pursuing weight loss and should be under the direct care of a physician. Therefore women who are pregnant or who are anticipating they might be pregnant should not participate in this study. If a woman becomes pregnant during the study, she will be advised to consult with her healthcare provider and will be dropped from the weight loss study.
* should be free of an eating disorder as screened by the Eating disorder Screen for Primary care \[ESP\]. (If a participant has an eating disorder, they will be given contact information for the eating disorder clinic at the University of South Carolina)
* no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
* no recent or planned bariatric surgery
* no recent weight loss (\>10 lbs in the last 6 months)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared three different diets for people with type 2 diabetes and measured changes in blood sugar control using HbA1c — which of the three diets tested might align best with how I currently eat, and is there any early evidence from this completed trial about which one showed the most meaningful change in HbA1c?
2Since this trial is now completed and was measuring real-world diet quality changes alongside body weight, has any published data come out that you think is relevant to my own diabetes management plan?
3This study wasn't testing a drug — it was comparing dietary approaches — so how does the evidence from a completed dietary intervention study like this compare to what you'd recommend for me through standard nutritional counseling or a registered dietitian?
4Body weight was one of the key things being tracked in this trial — given my current weight and diabetes status, do you think a structured dietary intervention like the ones studied here could realistically be part of my treatment plan, or are there other priorities we should address first?
5Since this trial has finished, is there a way for me to access its findings or ask about what dietary patterns were tested, so I can have a more informed conversation with you and my care team about changes I might make at home?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delta Dietary Quality
Timeframe: From baseline to the end of the intervention at 3 months
2
Delta Body Weight
Timeframe: From baseline to the end of the intervention at 3 months
3
Delta Hemoglobin A1c
Timeframe: From baseline to the end of the intervention at 3 months