Meal Replacement and Lifestyle Modification for Obesity

(ADMIRE Trial)

Overseen By Justin Ryder, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Anti-obesity, Supplemental hormones

Disqualifiers: Bariatric surgery, Diabetes, Cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why people often regain weight after losing it and whether hormones play a role. Participants will first follow a meal plan of shakes and frozen meals for eight weeks, along with lifestyle change guidance, known as Meal Replacement Therapy (MRT). Suitable candidates are children aged 11-15 with a high BMI and certain stages of physical development. The trial lasts up to 35 weeks, including multiple visits and check-ins. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on weight management in adolescents.

Will I have to stop taking my current medications?

The trial requires that you have not used certain anti-obesity medications like orlistat, metformin, or phentermine in the 3 months before joining. If you are currently using these, you would need to stop before participating.

What prior data suggests that this meal replacement and lifestyle modification is safe for weight management?

Research has shown that meal replacement products can aid in weight and body fat loss without affecting the body's energy and nutrient management. One study found that participants using meal replacements for 15 months lost an average of 3.8% of their starting weight.

These meal replacements are generally safe, and most people can use them without serious side effects. They provide balanced nutrients, supporting health during weight loss. However, adherence to the diet can decline over time. Another study found that adherence dropped from 81% in the first month to 57% after two years.

Overall, meal replacements are considered safe for weight loss, and many people use them successfully. However, like any dietary change, it's important to follow the guidelines and consult a healthcare provider if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about meal replacement and lifestyle modification for obesity because it offers a structured, convenient approach to weight loss that could simplify calorie control. Unlike standard treatments that might involve more complex meal planning or medications, this method uses meal replacement shakes and frozen meals to ensure a balanced diet with minimal effort. Additionally, the regular lifestyle and behavioral counseling helps reinforce positive habits, which can lead to sustained weight loss and healthier living. This combination of readily available meal options and ongoing support could make it easier for people to achieve and maintain their weight loss goals.

What evidence suggests that meal replacement and lifestyle modification might be an effective treatment for obesity?

Research has shown that meal replacement diets can lead to significant weight loss. In this trial, participants will follow a meal replacement plan combined with lifestyle and behavioral modification counseling. One study found that individuals using meal replacement plans lost more weight than those consuming regular meals. Another study demonstrated that participants continued to lose weight with these plans for over six months. Meal replacements can also reduce body fat without compromising overall health. Lifestyle and behavior changes can further enhance these outcomes. ^{1 4 6 7 8}

Who Is on the Research Team?

Justin Ryder, PhD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for young individuals aged 11 to less than 16 with severe obesity, measured by a BMI >30 kg/m^2 or above the 95th percentile. They should be in the middle stages of puberty (Tanner stage 2-4). Those who are pregnant, have had bariatric surgery, use certain weight-loss drugs, have specific health conditions like polycystic ovary syndrome or thyroid issues, cancer within the last decade, hormonal treatments, genetic obesity forms or diagnosed eating disorders can't participate.

Inclusion Criteria

My body is in the middle stages of puberty.

BMI > 30 kg/m^2 or 95th BMI percentile

I am between 11 and 15 years old.

Exclusion Criteria

I have been diagnosed with an eating disorder such as anorexia, bulimia, or binge eating.

I have diabetes.

I have used weight loss medication in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Meal Replacement Therapy

Participants undergo an 8-week meal replacement therapy period to reduce BMI by >5% with a prescribed eating regimen

8 weeks

4 visits (in-person), 4 visits (virtual)

Follow-up

Participants are monitored for changes in fat mass and hormone levels after initial weight loss

17 weeks

6 visits (in-person), 9 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Meal replacement and lifestyle modification

Trial Overview The study tests if meal replacements and lifestyle changes affect why youth regain weight after dieting. Participants will replace two meals with shakes and eat a calorie-controlled dinner for a period followed by observation. The goal is to understand hormone roles in weight regain post-dieting.

How Is the Trial Designed?

Group I: Meal Replacement and Lifestyle Therapy Experimental Treatment 1 Intervention

Participants in this study will have an 8-week meal replacement therapy period in which they are asked to reduce their BMI by 5% by following a prescribed eating regimen consisting of meal replacement shakes and/or frozen meals for breakfast and lunch. For dinner they will consume a pre-packaged frozen entree to be consumed with two servings of fruit and three servings of vegetables per day. Participants will also have lifestyle/behavioral modification counseling every 2 weeks throughout the entire study.

Meal replacement and lifestyle modification is already approved in United States, European Union for the following indications:

Approved in United States as Meal Replacement Therapy for:

• Weight Management
• Obesity Treatment

Approved in European Union as Meal Replacement Therapy for:

• Weight Loss
• Obesity Management

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

A systematic review of 23 studies involving 7884 adults found that weight loss interventions incorporating meal replacements (MR) led to greater weight loss at 1 year compared to alternative diets, with an average difference of -1.44 kg.

When MR was combined with enhanced support, participants experienced even more significant weight loss, averaging -6.13 kg compared to other diets with regular support, suggesting that MR can be an effective strategy for managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of the effectiveness of meal replacements for weight loss. Astbury, NM., Piernas, C., Hartmann-Boyce, J., et al.[2021]

A study involving 17 adolescents with severe obesity revealed that their engagement in meal replacement therapy (MRT) was influenced by three key factors: scheduling and planning, social support, and intrapersonal changes like self-confidence.

Adolescents reported that while planning and social support helped them succeed in MRT, challenges such as unplanned changes and social pressures could hinder their progress, highlighting the need for personalized approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opinions from the experts: Experiences of adolescents with severe obesity participating in meal replacement therapy. Khayutin, S., Kelly, AS., Fox, CK., et al.[2023]

In a study involving 61 participants in meal replacement programs, key barriers to weight loss included challenges with program products, physical activity, and social settings, while facilitators included personal benefits and family support.

For weight loss maintenance, barriers included nutrition knowledge and physical activity, while effective health coach support and personal motivation were identified as crucial facilitators, highlighting the importance of tailored health coaching in overcoming obstacles to long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to and Facilitators of Weight Management in Adults Using a Meal Replacement Program That Includes Health Coaching. Kleine, HD., McCormack, LA., Drooger, A., et al.[2020]

In a study of 238 overweight patients, those who used meal replacements (MRs) combined with an energy density (ED) intervention maintained significantly less weight regain over 2 years compared to other groups, highlighting the effectiveness of this combination for long-term weight management.

The study found that while most participants regained weight after a 12-week weight loss phase, the ED+/MR- group showed the best results in maintaining weight loss, suggesting that specific dietary strategies can play a crucial role in weight maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meal replacements, reduced energy density eating, and weight loss maintenance in primary care patients: a randomized controlled trial. Lowe, MR., Butryn, ML., Thomas, JG., et al.[2021]

In a study of 112 patients with obesity, both one and two meal replacement strategies led to significant weight loss and reductions in fat mass over three months, with no significant difference between the two approaches.

Both strategies also improved cardiovascular risk factors, including lower blood pressure and cholesterol levels, indicating that either meal replacement strategy can be effective for weight management and health improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Two Meal Replacement strategies on Cardiovascular Risk Parameters in Advanced Age Patients with Obesity and Osteoarthritis. López-Gómez, JJ., Izaola-Jauregui, O., Primo-Martín, D., et al.[2020]

In a study involving overweight or obese Chinese individuals with hyperlipidemia, a high-protein meal replacement diet led to a significant reduction in waist-hip ratio compared to a standard-protein diet over 12 weeks.

While both high-protein and standard-protein diets resulted in weight loss and decreased triglycerides, the high-protein diet showed a trend towards better outcomes, suggesting it may be a beneficial strategy for managing abdominal obesity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Protein-Enriched Meal Replacement on Waist Circumference Reduction among Overweight and Obese Chinese with Hyperlipidemia. Chen, W., Liu, Y., Yang, Q., et al.[2017]

A study involving 262 overweight and obese individuals found that a nutrition-focused intervention aimed at modifying the home food environment led to greater long-term weight loss compared to behavior therapy alone, with a mean weight loss of 10.97% at 12 months for the home food environment group.

The increase in cognitive restraint among participants in the home food environment group was a key factor in their improved weight loss, suggesting that changing one's food environment can enhance self-control and support weight management efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of meal replacements and a home food environment intervention for long-term weight loss: a randomized controlled trial. Lowe, MR., Butryn, ML., Zhang, F.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34144920/

The Effect of Meal Replacement on Weight Loss According ... Conclusions: The effect of MR-based LED on weight loss was superior to the effect of food-based LED, and receiving ≥60% of total daily energy ...

2. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15819

The latest evidence and clinical guidelines for use of meal ... Contemporary clinical trials of TDR of more than 6 months demonstrate consistent mean weight loss in a variety of clinical settings, disease ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20222968/

Efficacy of a meal replacement diet plan compared to ... Our data suggest that the meal replacement diet plan evaluated was an effective strategy for producing robust initial weight loss and for achieving improvements

4. mdpi.com mdpi.com/2072-6643/16/19/3284

A 90-Day Randomized Controlled Trial in Adults with Obesity The results indicate that meal replacement products can significantly reduce weight and body fat percentage without affecting metabolic health.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522042575

Metabolic and weight-loss effects of a long-term dietary ... We assessed the long-term effects of an energy-restricted diet combined with 1 or 2 daily meal replacements on body weight and biomarkers of disease risk in 100 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7773341/

Dietary interventions for obesity: clinical and mechanistic ... Across diets, self-reported adherence was 81% in the first month of the intervention and dropped to 57% at 24 months, with no significant differences among ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11479124/

Efficacy of Meal Replacement Products on Weight and ... The results indicate that meal replacement products can significantly reduce weight and body fat percentage without affecting metabolic health.

8. mhealth.jmir.org mhealth.jmir.org/2024/1/e47104

Half-Year Follow-Up Results of a Randomized Controlled Trial The use of a food replacement product might be a reason why the participants in the intervention group did not experience a significant loss of ...