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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a stable, healthy meal plan (meal provisioning) can help women facing food insecurity manage their weight more effectively. Research tests if regular, personalized meals can improve metabolism and reduce cravings for unhealthy foods. Participants will receive bi-weekly meal deliveries and learn skills for better eating and lifestyle habits. Women who are obese, have prediabetes, experience food insecurity, and live alone may be suitable candidates for this study. As an unphased trial, it offers participants the opportunity to gain valuable skills and support for healthier living.

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 prior data suggests that meal provisioning is safe for improving metabolism and reducing unhealthy eating motivation?

Research has shown that providing meals to those in need is generally safe and can lead to better health. A review of studies found that meal timing and frequency can affect weight and metabolism, potentially aiding those who are overweight. Specifically, eating fewer meals each day proved slightly more effective for weight loss than eating more frequently.

Additionally, research on school meal programs indicates that these initiatives can improve diet quality and help ensure food security. This ensures that individuals receive necessary nutrition without the stress of food scarcity. These findings suggest that planned meal programs are not only safe but also beneficial for health.

While these studies reported no specific negative effects, it is important to monitor how the body responds and consult a healthcare provider if any concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the meal provisioning approach for obesity because it offers a personalized and comprehensive strategy that differs from standard treatments like diet pills or general dietary advice. Unlike typical methods, this approach includes bi-weekly home deliveries of meals tailored to an individual's metabolic rate, aiming for efficient weight loss of about 1-2 pounds per week. Additionally, it combines this with behavioral skills training, which not only supports short-term weight loss but also focuses on long-term lifestyle changes, such as self-monitoring and goal setting, to sustain results over time. This holistic approach could provide more sustainable outcomes compared to traditional weight loss methods.

What evidence suggests that meal provisioning is effective for obesity?

Research has shown that meal provision can significantly aid in weight loss. In this trial, participants in the treatment phase will receive bi-weekly home deliveries of three meals a day, personalized based on their resting metabolic rate. Studies found that 61% of people who received all their meals through a structured program lost at least 5% of their body weight, compared to only 22% of those without meal provision. Additionally, meal delivery has been linked to greater weight loss over 6, 12, and 18 months compared to those without this support. Regular, planned meals can help manage weight and improve overall health. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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

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

Experiencing food insecurity (score of 2-6 on the six-item food insecurity questionnaire)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825747

Meal Timing and Anthropometric and Metabolic Outcomes This systematic review and meta-analysis evaluates the association between meal timing strategies and anthropometric and metabolic outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4282314/

Weight loss in a UK commercial all meal provision study In terms of clinically relevant weight loss, 61% of participants lost 5% or more of their body weight with meal provision compared to 22% on the ...

3. cdn.nutrition.org cdn.nutrition.org/article/S2475-2991(24)01485-9/fulltext

A Systematic Review of the Effectiveness of Meal Provision for ... Most studies showed significant weight changes, but the studies had varied approaches, and more consensus is needed for weight loss plans.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322000448

Impact of Meal Frequency on Anthropometric Outcomes Research has shown that, in adults with overweight and obesity, a reduction in body weight of 5–10% of initial body weight was associated with improvements ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1038/oby.2001.130

Food Provision as a Strategy to Promote Weight Loss At 6, 12, and 18 months, weight losses in the two groups receiving food provision were significantly greater than in the two groups without food ...

6. nutrition.bmj.com nutrition.bmj.com/content/early/2024/04/21/bmjnph-2023-000663

Food environment and obesity: a systematic review ... Food outlets which sell mostly unhealthy and ultra-processed foods were associated with higher levels of obesity.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11533393/

Health outcomes reported by healthcare providers and ... Two-thirds of clients reported food insecurity (66%) and more than half of clients were at high risk of malnutrition (56%). Clients were not ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12081475/

School-Provided Meals and the Prevention of Childhood ... SPMs can positively impact diet quality, household food and nutrition security and potentially weight status but is dependent on the model.