Dietary Intervention for Healthy Habits and Diet

Recruiting at 1 trial location

Overseen By Dan Sleeper

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zoe Global Limited

Disqualifiers: Pregnancy, Recent heart attack, 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: Unknown

250000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to check with your primary care physician to ensure the study is safe for you.

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

Research shows that personalized and frequent dietary counseling can be effective in treating obesity, and patients report positive outcomes from nutrition counseling, suggesting that these approaches can help people develop healthier eating habits. ^{1 2 3 4 5}

Is dietary intervention generally safe for humans?

The research articles reviewed do not report any safety concerns related to dietary interventions, nutritional counseling, or dietary therapy, suggesting these approaches are generally safe for humans. ^{2 3 6 7 8}

How does the dietary intervention treatment differ from other treatments for healthy habits and diet?

The dietary intervention treatment is unique because it combines nutrition education with behavioral change strategies, such as self-monitoring and coping skills, to effectively modify dietary behavior. Unlike other treatments that may focus solely on providing dietary information, this approach emphasizes the psychological and cultural aspects of eating, making it more comprehensive and potentially more effective in achieving lasting dietary changes. ^{6 8 9 10 11}

What is the purpose of this trial?

The PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science.

Research Team

Tim Spector, PhD

Principal Investigator

Zoe Global Limited

Eligibility Criteria

The trial is for adults who are part of the ZOE testing program, have a BMI of at least 16.5 kg/m2, and live in the continental US (excluding New York) or UK. They must be able to follow the study protocol and give informed consent. Those with chronic conditions should consult their doctor before joining.

Inclusion Criteria

Your body mass index (BMI) is 16.5 or higher.

Under care for chronic medical conditions (including eating disorders, type 1 diabetes, type 2 diabetes), and confirm they have checked with their primary care physician that this study is safe for them (US cohort only)

You are currently participating in the ZOE testing program for commercial purposes.

Exclusion Criteria

Are pregnant

Are unable to read and write in English, as the ZOE app is only available in English

I cannot safely eat standard US meals due to allergies or recent surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dietary Intervention

Participants undergo a dietary intervention with standardized test meals to measure postprandial metabolic response.

6-14 days

Regular contact via phone, app, and text messages

Free-living Monitoring

Participants track all meals, snacks, and drinks using a digital app, and monitor lifestyle factors such as sleep and physical activity.

Up to 14 days

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention, with optional follow-on study for dietary guidance.

12 months

Monthly reporting

Treatment Details

Interventions

• Dietary Intervention

Trial Overview This study tests how different foods affect individuals by using machine learning models to predict responses to diet. Participants will undergo controlled dietary interventions and record their meals during a free-living period to assess various factors' impact on post-meal responses.

Participant Groups

Group I: Dietary Intervention Experimental Treatment 1 Intervention

Dietary intervention using standardized test meals after which the postprandial metabolic response is measured.

Who Is Running the Clinical Trial?

Zoe Global Limited

Lead Sponsor

Trials

12

Recruited

11,450,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

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]

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]

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]

A study involving 64 obese patients showed that personal and ongoing dietary counseling led to a greater average weight loss (3.9 kg) at 2 months compared to a control group (2.2 kg), indicating some effectiveness of the intervention.

However, the overall efficiency of the dietary counseling intervention was deemed low, as the weight loss differences between the groups were not significant at 4 months, suggesting that the resources used may not justify the modest outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of personalized and frequent dietetic counseling in the treatment of obesity]. Vila Córcoles, A., Llor Vilá, C., Pellejá Pellejá, J., et al.[2016]

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]

Diet significantly influences health, cognitive performance, and psychological well-being, but simply providing information about healthy eating is often not enough to change dietary behaviors.

Successful dietary interventions must combine nutrition education with behavioral psychology strategies, such as self-monitoring and coping skills, to effectively promote and maintain dietary changes across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to dietary regimens. 2: Components of effective interventions. Brownell, KD., Cohen, LR.[2016]

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. 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]

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

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

5. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of personalized and frequent dietetic counseling in the treatment of obesity]. [2016]

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. Japan pubmed.ncbi.nlm.nih.gov

Lifestyle changes through the use of delivered meals and dietary counseling in a single-blind study. The STYLIST study. [2022]

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

Adherence to dietary regimens. 2: Components of effective interventions. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Healthy eating counseling : Clinical and community perspectives]. [2021]

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

How to implement dietary changes to prevent the development of metabolic syndrome. [2019]