Dietary Intervention for Eating Habits

(EATS Trial)

Overseen By Frank A.J.L. Scheer, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Smoking, Drug dependency, Psychiatric illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications, except for oral contraceptives, to participate in this trial.

What data supports the effectiveness of the treatment Dietary Intervention, Nutritional Counseling, Dietary Therapy?

Research shows that patient-centered counseling, which tailors dietary advice to individual needs and challenges, can improve long-term adherence to dietary changes. Additionally, patients report positive outcomes from nutrition counseling, suggesting it can effectively support dietary improvements. ^{1 2 3 4 5}

Is dietary intervention generally safe for humans?

The research does not specifically address safety concerns, but dietary interventions like nutritional counseling and dietary therapy are generally considered safe as they focus on improving eating habits and are often used to manage conditions like diabetes and heart disease. ^{2 6 7 8 9}

How is the dietary intervention treatment different from other treatments for eating habits?

This dietary intervention is unique because it focuses on personalized nutritional counseling, which involves active problem-solving and developing self-efficacy (confidence in one's ability to make changes) to help patients adopt lasting healthy eating habits. Unlike traditional methods, it considers the patient's environment and uses participatory workshops to practice new skills, making it more adaptable and potentially more effective. ^{2 4 6 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to test the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure. Participants will: complete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, and stool samples

Research Team

Frank AJL Scheer, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for healthy adults aged 18-45 with a BMI of 18.5 to 29.9, who don't smoke or vape and have no history of substance dependency or psychiatric illness. Participants should not have any chronic health conditions like heart disease, diabetes, or cancer.

Inclusion Criteria

BMI 18.5-29.9

I do not have any serious ongoing health issues.

Exclusion Criteria

History of drug or alcohol dependency

History of psychiatric illness or disorder

I am currently smoking/vaping or have smoked/vaped for 5+ years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention A-B

Participants undergo Dietary A followed by Dietary B intervention with standard meals and real-time food intake recording

7 days

2 field-based dietary interventions

Dietary Intervention B-A

Participants undergo Dietary B followed by Dietary A intervention with standard meals and real-time food intake recording

7 days

2 field-based dietary interventions

Inpatient Stay

Participants complete 2 inpatient stays with frequent blood draws and provide urine, saliva, and stool samples

2 days

2 inpatient stays

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietary Intervention

Trial Overview The study tests how different diets affect when people feel hungry and how their bodies use energy. It involves two diet interventions where participants eat provided meals, track their food intake in real-time, and stay at the clinic twice for monitoring including blood draws and other samples.

Participant Groups

Group I: Dietary B-A Intervention Experimental Treatment 1 Intervention

The Dietary B first, then the Dietary A intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes.

Group II: Dietary A-B Intervention Experimental Treatment 1 Intervention

The Dietary A first, then the Dietary B intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A study involving 400 adult patients showed that 83% of participants reported making dietary modifications after nutrition counseling, indicating effective communication and understanding of dietary advice.

Patients who received counseling felt better emotionally (57%) and physically (37%), and 64% felt more in control of their health, highlighting the positive impact of nutrition counseling on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients report positive nutrition counseling outcomes. Schiller, MR., Miller, M., Moore, C., et al.[2022]

Traditional dietary counseling methods often fail because they rely on generalized assumptions about patients' health values and abilities, which may not reflect individual needs.

Enhancing nutrition counseling by focusing on active problem-solving and building self-efficacy can help patients successfully adopt and maintain a heart-healthy diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting dietary change. Crawford, S.[2016]

In a study of 59 patients on continuous ambulatory peritoneal dialysis, dietary advice did not lead to significant changes in energy or protein intake over 4 months, indicating that patients struggled to adjust their diets according to recommendations.

While both groups showed similar adherence to dietary advice, the intervention group had a higher success rate in achieving the lower protein intake goal, suggesting that tailored dietary advice may help some patients meet their nutritional needs, but overall dietary adjustments were limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous ambulatory peritoneal dialysis patients are unable to increase dietary intake to recommended levels. Sutton, D., Higgins, B., Stevens, JM.[2007]

Diet counseling for protein restriction in 125 type 2 diabetic patients led to a modest decrease in protein intake, with reductions of 8 g/day and 15 g/day at 6 months according to urinary urea excretion and food-frequency questionnaires, respectively.

Factors such as satisfaction with the pre-existing diet, lower body weight, and living alone were associated with better adherence to protein restriction, but these factors only explained a small portion (11%) of the variation in adherence levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to protein restriction in patients with type 2 diabetes mellitus: a randomized trial. Pijls, LT., de Vries, H., van Eijk, JT., et al.[2019]

The patient-centered counseling model improves long-term dietary adherence by personalizing interventions based on individual patient needs and stages of change.

This model includes a 4-step counseling process that helps nutrition professionals effectively support patients in following nutrition care plans and dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating dietary change: the patient-centered counseling model. Rosal, MC., Ebbeling, CB., Lofgren, I., et al.[2022]

A pilot intervention using participatory workshops successfully helped refugees in Geneva reduce their fat consumption by an average of 58% per recipe, demonstrating a significant behavioral change.

The workshops led to a nine-fold increase in the use of oil-sparing techniques, suggesting that group-based approaches can be more effective than traditional one-on-one dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive group education for refugees from the Former Yugoslavia to reduce their oil consumption. Kruseman, M., Stoll, BE., Stalder, H.[2019]

Dietary changes, such as reducing fat and sodium while increasing fiber and fruit and vegetable intake, are crucial for lowering cardiopulmonary risks, yet less than half of U.S. adults follow these recommendations.

While various nutrition education and counseling methods can help improve dietary habits, most successes are seen in research settings with highly motivated individuals, highlighting the need for more practical, interdisciplinary studies to promote long-term dietary changes in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of dietary behavior change. Kumanyika, SK., Van Horn, L., Bowen, D., et al.[2019]

A systematic review of 214 articles identified strong evidence supporting the use of cognitive behavioral therapy (CBT) combined with behavioral theories to effectively change dietary habits and reduce risks for conditions like type 2 diabetes, particularly in patients undergoing intensive CBT for 6 to 12 months.

Motivational interviewing emerged as a highly effective counseling strategy, especially when paired with CBT, while strategies like financial rewards were found to be ineffective, highlighting the importance of goal setting and social support in nutrition counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the evidence regarding behavior change theories and strategies in nutrition counseling to facilitate health and food behavior change. Spahn, JM., Reeves, RS., Keim, KS., et al.[2022]

A short-term intensive nutritional counseling program significantly improved glycemic control in 75% of patients with type 2 diabetes, compared to only 31.6% in the conventional treatment group, highlighting the efficacy of structured dietary interventions.

Increased fiber intake was associated with better blood glucose control, suggesting that dietary adjustments, particularly in fiber consumption, play a crucial role in managing hyperglycemia in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Importance of nutritional counseling and dietary fiber content on glycemic control in type 2 diabetic patients under intensive educational intervention]. Carvalho, FS., Pimazoni Netto, A., Zach, P., et al.[2019]

Understanding the principles of social psychology, such as locus of control and communication models, can significantly enhance the effectiveness of nutritional counseling in motivating patients to change their eating behaviors.

Encouraging patients to take responsibility for their own dietary changes, as highlighted by attribution theory, is crucial for successful behavior modification in nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social-psychologic perspective in motivating changes in eating behavior. Evans, RI., Hall, Y.[2016]

The American Dietetic Association has developed procedural guidelines for dietary counseling, which include clarifying terminology and outlining necessary knowledge, skills, and equipment for effective counseling.

These guidelines are primarily aimed at dietitians in clinical and ambulatory care settings, but the principles can be applied broadly in various educational contexts, adapting to specific circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for diet counseling. [2019]

References

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

Patients report positive nutrition counseling outcomes. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Promoting dietary change. [2016]

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

Continuous ambulatory peritoneal dialysis patients are unable to increase dietary intake to recommended levels. [2007]

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

Adherence to protein restriction in patients with type 2 diabetes mellitus: a randomized trial. [2019]

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

Facilitating dietary change: the patient-centered counseling model. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Interactive group education for refugees from the Former Yugoslavia to reduce their oil consumption. [2019]

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

Maintenance of dietary behavior change. [2019]

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

State of the evidence regarding behavior change theories and strategies in nutrition counseling to facilitate health and food behavior change. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

[Importance of nutritional counseling and dietary fiber content on glycemic control in type 2 diabetic patients under intensive educational intervention]. [2019]

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

Social-psychologic perspective in motivating changes in eating behavior. [2016]

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

Guidelines for diet counseling. [2019]