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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how different diets affect eating times, hunger levels, and energy expenditure. Participants will follow two different diets and record their food intake. This study suits generally healthy individuals aged 18-45 with a BMI between 18.5 and 29.9, without special dietary restrictions or medical conditions.

As an unphased study, this trial provides a unique opportunity to contribute to understanding dietary impacts on health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that changing one's diet is safe for most people. One study found that patients undergoing chemotherapy handled dietary changes well, with no major side effects. Another review of various diet changes also found them to be both practical and safe for patients.

While some diets might cause issues like malnutrition and fatigue, these problems are usually linked to specific conditions and diets. Overall, many studies have shown that dietary changes are safe, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard dietary programs that often stick to one set plan, the Dietary Intervention being tested offers a unique twist by alternating between two different dietary approaches: Dietary A and Dietary B. This method could potentially provide more flexibility and adaptability to individual needs, which might lead to better adherence and long-term success in improving eating habits. Researchers are excited about this approach because it could reveal insights into how varying dietary patterns affect eating behaviors and health outcomes, helping to tailor future interventions more effectively.

What evidence suggests that this trial's dietary interventions could be effective for regulating eating habits?

Research has shown that changing one's diet can lead to healthier eating habits. In one study, 83% of participants altered their eating habits after receiving nutritional advice, demonstrating its effectiveness. Another study found that forming new habits and understanding the impact of food choices significantly improved dietary behavior. Although some changes were small, they became more noticeable when combined with other helpful strategies. This trial will compare two dietary interventions: the Dietary A-B Intervention and the Dietary B-A Intervention. Overall, these findings suggest that well-planned diet programs, like those tested in this trial, can successfully change eating habits and help control appetite. ^{6 7 8 9 10}

Who Is on the Research Team?

Frank AJL Scheer, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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

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

History of drug or alcohol dependency

History of psychiatric illness or disorder

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9196970/

Effectiveness of a Patient-Centered Dietary Educational ... Intervention patients had better knowledge of the MyPlate diet (P=0.009), felt it would be easier to change their diet (P=0.03), and were more motivated to have ...

2. withpower.com withpower.com/trial/phase-dietary-habits-8-2023-655b4

Dietary Intervention for Eating Habits (EATS Trial) A study involving 400 adult patients showed that 83% of participants reported making dietary modifications after nutrition counseling, indicating effective ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0738399121007886

Towards effective dietary counseling: a scoping review The aim of this scoping review was to identify and map available evidence concerning counseling strategies that contribute to effective DC.

4. mdpi.com mdpi.com/2072-6643/11/4/825

A Systematic Review and Meta-Analysis of RCTs The BCTs with the highest effectiveness ratio were habit formation (100%), salience of consequences (83%) and adding objects to the environment (70%). The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7353268/

Effectiveness of Interventions to Promote Healthy Eating ... Small effects of behavioral interventions were found to promote healthy eating habits, but better effects were shown in cases where the invention was followed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9542820/

Effectiveness of dietary counseling with or without nutrition ... Nutrition support is associated with improved survival and nonelective hospital readmission rates among malnourished medical inpatients; however, ...

7. nature.com nature.com/articles/s41392-024-01771-x

Effects of dietary intervention on human diseases These dietary practices could exacerbate the risk of malnutrition, sarcopenia, fatigue, delayed wound healing, and impaired immunity, ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/01635581.2024.2406999?src=

Dietary Counseling Interventions During Radiation Therapy In conclusion, this systematic review compiles feasibility, safety, and efficacy of 32 publications from 27 clinical trials on dietary ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424001742

Feasibility, safety, and efficacy of dietary or lifestyle ... Studies assessing feasibility, safety, or efficacy of any dietary or lifestyle intervention in children with hypothalamic overweight or obesity, were included.

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39851919/

A Systematic Review of Feasibility, Safety, and Efficacy Nutritional interventions were feasible and safe for patients undergoing chemotherapy and demonstrated preliminary efficacy to improve nutritional status, ...