Meal Replacement and Lifestyle Modification for Obesity

(ADMIRE Trial)

Overseen by Justin Ryder, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Minnesota

Must not be taking: Anti-obesity, Supplemental hormones

Disqualifiers: Bariatric surgery, Diabetes, Cancer, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables. Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.

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 data supports the effectiveness of the treatment Meal Replacement and Lifestyle Modification for Obesity?

Research shows that meal replacement programs can lead to greater weight loss compared to other diets, with some studies indicating a weight loss of up to 6.13 kg more than alternative diets when combined with support. However, weight regain is common, with up to 50% of weight lost being regained within a year. ^{1 2 3 4 5}

Is meal replacement therapy generally safe for humans?

Meal replacement therapy (MRT) is generally considered safe for humans, as supported by the Academy of Nutrition and Dietetics, which endorses it as an effective weight management strategy. However, like any diet program, individual responses can vary, and some people may experience weight regain after stopping the program. ^{1 2 4 5 6}

How is Meal Replacement Therapy different from other obesity treatments?

Meal Replacement Therapy (MRT) is unique because it involves replacing one or more meals with a specially formulated nutritional supplement, which can help control calorie intake and promote weight loss. Unlike some other treatments, MRT provides a structured approach that can be combined with lifestyle changes to improve long-term weight management. ^{1 2 3 6 7}

Research Team

Justin Ryder, PhD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Meal replacement and lifestyle modification (Other)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Dr. Michael D. Kelleher

Ann & Robert H Lurie Children's Hospital of Chicago

Chief Medical Officer since 2012

MD from University of Chicago

Dr. Thomas Shanley

Ann & Robert H Lurie Children's Hospital of Chicago

Chief Executive Officer since 2019

MD from University of Chicago Pritzker School of Medicine

Findings from Research

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]

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]

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]

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 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]

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]

References

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

Opinions from the experts: Experiences of adolescents with severe obesity participating in meal replacement therapy. [2023]

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

Barriers to and Facilitators of Weight Management in Adults Using a Meal Replacement Program That Includes Health Coaching. [2020]

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

Evaluation of meal replacements and a home food environment intervention for long-term weight loss: a randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of the effectiveness of meal replacements for weight loss. [2021]

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

Meal replacements, reduced energy density eating, and weight loss maintenance in primary care patients: a randomized controlled trial. [2021]

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

The Effect of Protein-Enriched Meal Replacement on Waist Circumference Reduction among Overweight and Obese Chinese with Hyperlipidemia. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Two Meal Replacement strategies on Cardiovascular Risk Parameters in Advanced Age Patients with Obesity and Osteoarthritis. [2020]