Meal Provisioning for Obesity

(IMPACT Trial)

Overseen By Leonard H. Epstein, PhD Experimental Psychology

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must not be taking: GLP-1 agonists

Disqualifiers: Pregnancy, Non-ambulatory, Mood disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 25 weeks

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Meal Provisioning for obesity?

Research shows that providing specific meal plans and the actual food to overweight patients can significantly improve weight loss. This suggests that meal provisioning, which involves giving people the meals they should eat, can be an effective way to help manage obesity. ^{1 2 3 4 5}

Is meal provisioning safe for humans?

Meal replacement products, which are similar to meal provisioning, have raised safety concerns among healthcare professionals, particularly regarding weight cycling (repeated loss and gain of weight) and its potential negative psychological effects. However, with proper training and understanding, these products are more likely to be prescribed, suggesting that they can be safe when used correctly. ^{4 6 7 8 9}

How does the Meal Provisioning treatment for obesity differ from other treatments?

Meal Provisioning is unique because it focuses on providing structured meal assistance to optimize nutrition and reduce the risk of malnutrition, unlike other obesity treatments that may focus on medication or surgery. This approach aims to ensure patients have access to healthy meals, potentially reducing food waste and improving dietary habits. ^{2 10 11 12 13}

What is the purpose of this trial?

This study aims to explore how food insecurity, a lack of consistent access to enough food, may lead to changes in the body that make it harder to lose weight. The investigators are testing whether providing women experiencing food insecurity with a stable, healthy, and personalized meal plan can improve their metabolism and reduce their motivation to eat unhealthy foods. The hypothesis is that addressing food insecurity with a predictable diet can lower a person's respiratory quotient (a measure of how the body uses energy), promote fat burning, and improve overall health. This research will improve the understanding for how food insecurity contributes to obesity and may lead to better solutions for managing weight in individuals facing these challenges.

Eligibility Criteria

This trial is for women who are dealing with obesity or obesity combined with Type 2 diabetes and are experiencing food insecurity. They should not have a consistent access to enough food, which may affect their weight loss efforts.

Inclusion Criteria

My BMI is 30 or higher.

Diagnosed with prediabetes (HbA1c: 5.7%-6.4%)

Income below 300% of the household federal poverty threshold

Exclusion Criteria

Actively planning to become pregnant (e.g., individuals trying to conceive or undergoing fertility treatment, based on self-report)

Delivered a baby within the past 6 months (self-report)

I have lost more than 5% of my weight in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

Participants maintain typical behaviors and do not change any normal patterns of activity/eating

4 weeks

Treatment

Participants receive bi-weekly home deliveries of personalized meals and undergo behavioral skills training

25 weeks

Bi-weekly home deliveries

Follow-up

Participants are monitored for changes in metabolic and behavioral factors after treatment

4 weeks

Treatment Details

Interventions

• Meal Provisioning

Trial Overview The study tests if providing these women with stable, healthy meals can improve metabolism and reduce the urge to eat unhealthy foods. It will check changes in how their bodies use energy and whether this can help burn fat better.

Participant Groups

Group I: Treatment phase Experimental Treatment 2 Interventions

There are two components to the treatment: Food provisioning: The food provisioning component will consist of bi-weekly home deliveries of three meals a day. The number of calories in the provided meals for each day will be personalized based on each participant's resting metabolic rate. Caloric targets for each participant will be 20% of TDEE as this translates to \~1-2 pounds of weight loss per week. Diets composition will also be tailored to help improve TEF and RQ. Behavioral Skills Training: This will be based on an evidence-based behavioral weight-loss program developed in our lab. This treatment has shown clinically significant weight loss with positive effects sustained over 10-years. The specific includes lessons on self-monitoring, developing alternatives to foods, meal-planning, goal setting, episodic future thinking, physical activity, and self-reinforcement.

Group II: Control phase Active Control 1 Intervention

During this phase, participants are told to maintain typical behaviors and not change any normal patterns of activity/eating.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

In a study of 163 overweight women, those who received structured meal plans and grocery lists lost significantly more weight than those who only participated in a standard behavioral treatment program, with weight loss averages of -12.0 kg compared to -8.0 kg after six months.

The study found that providing free food did not lead to additional weight loss benefits, indicating that the key factor for success was the structured meal planning rather than the actual provision of food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food provision vs structured meal plans in the behavioral treatment of obesity. Wing, RR., Jeffery, RW., Burton, LR., et al.[2014]

Implementing a co-designed mealtime assistance process in a 31-bed ward led to a significant reduction in wasted meals from an average of 3 per day to 0, which also decreased food waste by 0.43 kg per patient daily.

Patients who received mealtime assistance showed no new incidences of aspiration pneumonia or swallowing difficulties, indicating that the intervention not only improved meal access but also enhanced patient safety and nutritional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing risk of development or exacerbation of nutritional deficits by optimizing patient access to mealtime assistance. Teeling, SP., Coetzee, H., Phillips, M., et al.[2020]

Meal replacement products (MRPs) are effective for weight loss in obesity management, but are prescribed to only about 7% of patients by healthcare professionals (HCPs), despite over 70% having prescribed them at some point.

Safety concerns, particularly regarding long-term weight loss durability and the risk of weight cycling, hinder MRP prescriptions; however, HCPs with formal training in MRPs are 66% more likely to prescribe them, indicating that education could improve their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and Approaches to Use of Meal Replacement Products among Healthcare Professionals in Management of Excess Weight. Maston, G., Franklin, J., Gibson, AA., et al.[2023]

Home-delivered meal services, like Meals on Wheels, can enhance energy and protein intake for older adults by including protein-enriched options and providing full-day meal plans, according to a systematic review of 19 studies.

Despite the positive outcomes, none of the studies were rated as high quality, highlighting the need for further research to optimize these meal services for better nutritional care at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. IJmker-Hemink, VE., Dijxhoorn, DN., Briseno Ozumbilla, CM., et al.[2020]

The novel FoodforCare meal service significantly improved protein and energy intake among patients compared to the traditional meal service, with notable increases in intake on both the first and fourth days of full oral intake.

Patient satisfaction with the meal service remained stable, but the FoodforCare group reported better satisfaction regarding the appearance and smell of the meals, indicating a positive reception of the new service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. Dijxhoorn, DN., van den Berg, MGA., Drenth, JPH., et al.[2018]

Patients using the Meals on Wheels system had a mean total daily food intake that was 236 grams higher compared to those in the control group, indicating improved nutritional support.

The Meals on Wheels program not only reduced food waste but also enhanced patient satisfaction regarding food choice, quality, and organization, suggesting a more effective meal distribution system for hospitalized patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher food intake and appreciation with a new food delivery system in a Belgian hospital. Meals on Wheels, a bedside meal approach: a prospective cohort trial. Goeminne, PC., De Wit, EH., Burtin, C., et al.[2015]

A study involving 18 participants showed that providing real-time feedback on chew counts can significantly reduce the amount of food consumed during meals without impacting feelings of hunger or fullness.

Targeting a 25% reduction in chew counts led to decreased mass and energy intake, suggesting that wearable sensor systems could be effective tools for managing food intake and developing personalized dietary strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of energy intake using just-in-time feedback from a wearable sensor system. Farooq, M., McCrory, MA., Sazonov, E.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Food provision vs structured meal plans in the behavioral treatment of obesity. [2014]

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

Reducing risk of development or exacerbation of nutritional deficits by optimizing patient access to mealtime assistance. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring Overnutrition, Overweight, and Obesity in the Hospital Setting-A Point Prevalence Study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Attitudes and Approaches to Use of Meal Replacement Products among Healthcare Professionals in Management of Excess Weight. [2023]

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

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Acceptability and potential effectiveness of commercial portion control tools amongst people with obesity. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Higher food intake and appreciation with a new food delivery system in a Belgian hospital. Meals on Wheels, a bedside meal approach: a prospective cohort trial. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring the Experiences of People with Obesity Using Portion Control Tools-A Qualitative Study. [2023]

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

Reduction of energy intake using just-in-time feedback from a wearable sensor system. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[An approach for planning hospital menus using a knowledge-based system]. [2019]

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

Usability Study of a Novel Tool: The Virtual Cafeteria in Nutrition Education. [2021]

13. Singapore pubmed.ncbi.nlm.nih.gov

Pocket Dietitian: Automated Healthy Dish Recommendations by Location. [2020]