Decision-Making Skills for Adolescent Obesity

(REACH Trial)

Overseen By Adam Payne-Reichert, B.S.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Bariatric surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping adolescents understand how their decision-making affects their weight loss journey. Researchers are testing a weight loss program designed specifically for teens to assess how their choices around food and activity impact their success. The trial aims to identify which decision-making skills should be included in future programs for teens dealing with overweight or obesity. Teens aged 14-18, living at home with a parent or guardian, and able to use a smartphone to track food and activity, might be a good fit. Participants should not have conditions like diabetes or have undergone weight loss surgery.

As an unphased trial, this study offers a unique opportunity for teens to contribute to developing effective weight loss programs tailored to their needs.

Will I have to stop taking my current medications?

If you are taking medication specifically for weight loss, you will need to stop taking it to participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that this weight loss treatment is safe for adolescents?

Research has shown that weight loss programs designed specifically for teenagers can help them lose weight. One study found that teens lost weight by following plans like the Traffic Light Diet, with their Body Mass Index (BMI) dropping between 0.18 and 2.6 points. This suggests these programs can be effective.

However, not all studies show the same results. While many teens lose weight with these programs, some do not see significant changes. This indicates that although most teens handle these programs well, results can vary from person to person.

Overall, weight loss programs for teens are generally safe. They focus on improving eating habits and lifestyle choices, which usually carry a low risk of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the adolescent-specific behavioral weight loss treatment because it focuses on developing decision-making skills tailored to teens, which is a fresh approach compared to typical diet and exercise programs. Unlike standard treatments that often emphasize calorie counting or physical activity alone, this method aims to empower young people by improving their ability to make healthier lifestyle choices. This personalized strategy could lead to more sustainable weight loss and long-term health benefits for adolescents dealing with obesity.

What evidence suggests that this weight loss treatment might be effective for adolescent obesity?

Research has shown that programs focused on changing behavior can help teens lose a small amount of weight, averaging about 3.67 kg. Programs incorporating lifestyle changes have proven effective for some teens in maintaining weight loss over time. Out of 20 studies on these treatments, 17 found that they helped teens lose weight. These programs often lead to small decreases in BMI (Body Mass Index, a measure of body fat) over 6 to 12 months. ^{1 5 6 7 8}

Who Is on the Research Team?

Stephanie Manasse, Ph.D.

Principal Investigator

Drexel University

Are You a Good Fit for This Trial?

Adolescents aged 14-18 with obesity, defined as having a BMI between the 85th and 99th percentiles. Participants must have a smartphone, be willing to use an app and wear a fitness tracker for two weeks, and live at home in the US with parental involvement. Excluded are those on certain medications or with conditions affecting weight or ability to exercise.

Inclusion Criteria

You need to have a smartphone and be willing to download an app to track your food intake and complete surveys on your phone for two seven-day periods during the study. You also need to be willing to wear a fitness tracker during these same two week-long periods.

Have a BMI between the 85th and 99th percentiles for sex and age as determined by the CDC growth charts

Have at least one parent or guardian who is willing to participate in the study

Exclusion Criteria

You started taking or changed the dosage of a medication that can cause significant weight change recently.

You have been vomiting or using other severe methods to control your weight frequently (more than 12 times) in the past 3 months.

You have an immediate risk of attempting suicide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 16-week group-based, remotely delivered behavioral weight loss intervention

16 weeks

Follow-up

Participants are monitored for weight loss outcomes and problematic eating behaviors

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Weight loss treatment

Trial Overview The study is looking into how decision-making affects dieting behaviors and weight loss success in overweight teens. It aims to identify key factors that should be included in future interventions targeting adolescent decision-making related to food choices.

How Is the Trial Designed?

Group I: Adolescent-specific behavioral weight loss treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8182474/

Behavioral Weight Loss Intervention Preferences ... However, behavioral weight loss treatments to date have led to modest weight loss,10–12 with a reduction in weight of ∼3.67 kg. Additionally, while obesity in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7483247/

Obesity Treatment Among Adolescents: A Review of ... For some adolescents with obesity, multicomponent, intensive lifestyle modification programs can be effective for weight reduction, with long-term weight loss ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/15374416.2023.2251164

Evidence Base Update on Behavioral Treatments for ... Of these studies, 20 were RCTs, of which 17 were found to be effective in treating adolescents (3), adolescents and children (2), children (10), ...

4. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7420a1.htm

Prescriptions for Obesity Medications Among Adolescents ... A 2024 study reported an increase of 504% (among boys) to 588% (among girls) in the number of GLP-1RAs dispensed to U.S. adolescents during 2020 ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2820245

Interventions for Weight Management in Children and ... Behavioral weight management interventions were associated with small reductions in BMI and other weight outcomes after 6 to 12 months (BMI mean ...

6. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2819567

Financial Incentives and Treatment Outcomes in ... This study found that financial incentives improved outcomes of a dietary intervention among adolescents with severe obesity.

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04848532?term=drexel&recrs=abc&draw=2&rank=5

Problematic Decision-Making and Adolescent Weight Loss ... Unfortunately, adolescent outcomes from pediatric behavioral obesity treatments are poor. In fact, the modal weight loss in behavioral interventions is less ...

8. publications.aap.org publications.aap.org/pediatrics/article/151/2/e2022060640/190443/Clinical-Practice-Guideline-for-the-Evaluation-and

Clinical Practice Guideline for the Evaluation and ... This is the AAP's first clinical practice guideline (CPG) outlining evidence-based evaluation and treatment of children and adolescents with ...