Dietary Intervention for Type 2 Diabetes

(DG3D Trial)

Overseen By Brie Turner-McGrievy, PhD, MS, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Eating disorder, Bariatric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

63 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently taking weight loss medications.

What data supports the effectiveness of the treatment Dietary Intervention Meetings for Type 2 Diabetes?

Research shows that personalized dietary advice and nutrition therapy can help people with type 2 diabetes manage their blood sugar levels and improve overall health. Studies suggest that focusing on the total amount of carbohydrates in meals and providing basic information about food choices can be effective in reaching treatment goals. ^{1 2 3 4 5}

Is the dietary intervention for type 2 diabetes safe for humans?

The studies on dietary interventions for type 2 diabetes, such as low carbohydrate Mediterranean diets and nutritional interventions, generally focus on improving diabetes control and cardiovascular risk factors, suggesting they are safe for human use. ^{3 6 7 8 9}

How is the Dietary Intervention Meetings treatment for type 2 diabetes different from other treatments?

Dietary Intervention Meetings focus on changing eating habits and behaviors through structured meetings, which is different from standard drug treatments that typically involve medication. This approach emphasizes the role of dietitians and personalized dietary changes to manage type 2 diabetes, potentially improving outcomes by addressing individual eating patterns and behaviors. ^{5 7 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for African American adults living in Columbia, SC with overweight/obesity and at least three risk factors for type 2 diabetes. Participants should be aged 18-65, have a BMI of 25-49.9, and not suffer from major diseases or conditions like thyroid issues or diabetes. They must commit to attending all sessions and accept random diet assignments.

Inclusion Criteria

Live in the Columbia, SC area

Be willing to be randomized to either condition and be re-randomized if non-responsive

I can attend all required check-ups.

Exclusion Criteria

I am not in a weight loss program nor taking weight loss medications.

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)

I have not lost more than 10 pounds in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three dietary patterns (U.S.-Style, Mediterranean, or Vegetarian) for 12 weeks to assess dietary quality and T2DM risk factors

12 weeks

Follow-up

Participants are monitored for changes in dietary quality, body weight, and HgbA1c after the intervention

4 weeks

Treatment Details

Interventions

• Dietary Intervention Meetings

Trial Overview The study tests the adoption of three diets based on U.S. Dietary Guidelines over a period of 12 weeks: U.S.-Style, Mediterranean, or Vegetarian. The aim is to tailor these diets culturally for African Americans at risk of type 2 diabetes.

Participant Groups

Group I: Vegetarian diet Experimental Treatment 1 Intervention

Participants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains no meat, poultry, or seafood. Compared with the Healthy U.S.-Style Eating Pattern, it contains more soy products, eggs, beans and peas, nuts and seeds, and whole grains.

Group II: US Healthy Diet Experimental Treatment 1 Intervention

Participants in this group will be assigned to follow the Healthy US dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern is based on the types and amounts of foods Americans typically consume. The main types of food in this eating pattern include a variety of vegetables; fruits; whole grains; fat-free or low-fat dairy; seafood, poultry, meat, and eggs; and nuts, seeds, and soy products.

Group III: Mediterranean diet Experimental Treatment 1 Intervention

Participants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern. There is also less calcium and vitamin D because it includes fewer dairy foods.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Findings from Research

In a study of 136 Japanese adults with type 2 diabetes, individualized dietary advice led to a greater reduction in HbA1c levels (-1.1%) compared to conventional dietary advice (-0.7%) over 6 months, indicating its effectiveness in managing blood sugar levels.

Participants receiving individualized advice also made healthier dietary changes, such as reducing energy intake and consumption of sweets and fats, which contributed to improvements in weight and lipid profiles, although these changes were not significantly different from the conventional group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial. Omura, Y., Murakami, K., Matoba, K., et al.[2022]

Strong evidence indicates that the total amount of carbohydrates consumed is more crucial for managing diabetes than the specific type of carbohydrate, highlighting the importance of portion control and meal planning.

Nutrition therapy is effective in achieving treatment goals for blood sugar, lipids, and blood pressure in individuals with type 2 diabetes, and ongoing monitoring is essential to evaluate the effectiveness of lifestyle changes and medication adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prioritizing diabetes nutrition recommendations based on evidence. Franz, MJ.[2015]

The Expert Patient Programme (EPP) designed for individuals with Type 2 diabetes did not show any significant improvements in glycaemic control or dietary outcomes compared to individual dietitian appointments in a study of 317 adults.

Despite a slight increase in starch intake among the EPP group, the overall results indicate that the EPP approach was ineffective in promoting healthier eating habits or improving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can peer educators influence healthy eating in people with diabetes? Results of a randomized controlled trial. Cade, JE., Kirk, SF., Nelson, P., et al.[2022]

In a qualitative study involving 21 adults with type 2 diabetes, participants identified various dietary behavior change techniques (BCTs) like problem-solving and self-monitoring that they used to improve their diets after diagnosis.

Participants also recognized that their dietitians employed effective BCTs such as goal setting and providing instructions, suggesting that dietitians can enhance dietary behavior change by utilizing established behavior change taxonomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analyzing Dietary Behaviors Self-reported by People With Diabetes Using a Behavior Change Technique Taxonomy. Rigby, RR., Mitchell, LJ., Hamilton, K., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Prioritizing diabetes nutrition recommendations based on evidence. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Nutritional intervention in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment--Lifestyle Over and Above Drugs in Diabetes (LOADD) study: randomised controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Can peer educators influence healthy eating in people with diabetes? Results of a randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Eating Patterns and Health Outcomes in Patients With Type 2 Diabetes. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A low carbohydrate Mediterranean diet improves cardiovascular risk factors and diabetes control among overweight patients with type 2 diabetes mellitus: a 1-year prospective randomized intervention study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Effectiveness of Registered Dietitian Nutritionists in Healthy Behavior Interventions for Managing Type 2 Diabetes in Older Adults: A Systematic Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Resulting Variation in Nutrient Intake With the Inclusion of Walnuts in the Diets of Adults at Risk for Type 2 Diabetes: A Randomized, Controlled, Crossover Trial. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

The Diabetes Excess Weight Loss (DEWL) Trial: a randomised controlled trial of high-protein versus high-carbohydrate diets over 2 years in type 2 diabetes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Analyzing Dietary Behaviors Self-reported by People With Diabetes Using a Behavior Change Technique Taxonomy. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A symposium and workshop report from the Global Nutrition and Epidemiologic Transition Initiative: nutrition transition and the global burden of type 2 diabetes. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Eating behavior among persons with type 2 diabetes mellitus in North Ethiopia: a cross-sectional study. [2021]