Healthy Lifestyle Intervention for Obesity in Teens

(LIFT Trial)

Overseen By Rashon Braxton

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Not medically referred, refuses participation

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a healthy lifestyle program, supported by metabolic and bariatric surgery (MBS), can help teens manage obesity. The focus is on facilitating the adoption of healthier habits by teens, their families, and doctors, and assessing its effectiveness. Teens who may qualify have a body mass index (BMI) over 35 with a health issue like high blood pressure or a BMI over 40 and have received psychological clearance for surgery. The trial seeks to evaluate the practicality and effectiveness of this approach in improving health for teens with obesity. As an unphased trial, it offers a unique opportunity for teens to contribute to innovative research and potentially benefit from a comprehensive health program.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this healthy lifestyle behavioral intervention is safe for teens?

Research shows that healthy lifestyle programs for teens are generally safe. These programs typically involve dietary changes, increased physical activity, and counseling. Studies have found no serious harm from these programs. One review, in fact, found they can lower body mass index (BMI) without negative effects. They can also enhance mental health by reducing depression and improving quality of life. Overall, evidence suggests these programs are safe and well-received by teens. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for teen obesity, which often includes medications, surgery, or basic diet and exercise plans, the Healthy Lifestyle Behavioral Intervention focuses on creating sustainable lifestyle changes through behavioral modification. This approach is unique because it targets the psychological and social factors that influence eating and activity habits, rather than just addressing the physical symptoms. Researchers are excited about this treatment because it empowers teens to develop healthier habits that can last a lifetime, potentially reducing the need for more invasive treatments.

What evidence suggests that this healthy lifestyle behavioral intervention is effective for obesity in teens?

Research shows that programs focusing on healthy lifestyle changes can help treat obesity in teenagers. These programs usually include changes in diet and physical activity, along with guidance on behavior. The goal is to help teens develop healthier habits. Studies highlight that concentrating on overall lifestyle improvements, rather than just losing weight, can be more beneficial. Combining different elements like diet and exercise makes these programs more effective. This approach helps young people manage their weight better and improve their overall health. ^{1 2 6 7 8}

Who Is on the Research Team?

Sarah E Messiah, Ph.D., MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for teens with severe obesity, defined as having a BMI over 35 with related health issues like high blood pressure or cholesterol, or a BMI over 40. They must be considered candidates for bariatric surgery according to NIH guidelines and have received psychological clearance.

Inclusion Criteria

I am eligible for weight loss surgery based on my BMI and health conditions.

I am eligible for weight loss surgery based on my BMI and health conditions.

I have been cleared by a psychologist for surgery.

Exclusion Criteria

I do not want to participate in the study.

I have not been referred for weight loss surgery by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery

Participants undergo pre-surgery assessments and preparation

1 month

Surgery

Participants undergo metabolic and bariatric surgery

Post-surgery Treatment

Participants receive a healthy lifestyle behavioral intervention supported by the clinical team

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Lifestyle Behavioral Intervention

Trial Overview The study tests a healthy lifestyle behavioral intervention supported by Metabolic and Bariatric Surgery (MBS) teams. It aims to see if this approach is feasible, acceptable, and effective in helping obese adolescents and their families make positive changes.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a study involving 686 obese children aged 7-13, inpatient lifestyle treatment led to a significant short-term decrease in BMI-SDS, but long-term weight maintenance results were similar regardless of whether parents received additional cognitive-behavioral training or just written information.

Both groups showed improvements in quality of life, healthy food intake, and exercise, indicating that while inpatient treatment is effective, the inclusion of parent training did not enhance long-term outcomes for weight maintenance or psychosocial well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training. Warschburger, P., Kroeller, K., Haerting, J., et al.[2019]

The Coaching on Lifestyle programme (CooL) effectively helped adults achieve sustained improvements in motivation, lifestyle behaviors, quality of life, and weight over an 18-month period.

While adults showed significant positive changes, the program had mixed results for children and their parents, indicating that different strategies may be needed to engage younger participants effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. van Rinsum, C., Gerards, S., Rutten, G., et al.[2019]

Both short-stay (2 months) and long-stay (6 months) intensive lifestyle treatments for severely obese children resulted in significant reductions in SDS-BMI after one year, indicating that both approaches are effective.

There were no significant differences in outcomes between the two treatment durations, suggesting that the shorter treatment may be preferable due to its lower burden on children and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year effects of two intensive inpatient treatments for severely obese children and adolescents. Makkes, S., Renders, CM., Bosmans, JE., et al.[2023]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

In a study of 568 children and adolescents with severe obesity, 73% attended a one-year follow-up, showing a moderate mean reduction in key weight measures, including BMI and waist circumference, indicating that lifestyle interventions can be effective in this population.

About 65% of participants achieved a reduction in their percentage overweight, with 17% moving from severe obesity to obesity, highlighting that while the interventions had positive outcomes, individual responses varied significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention for children and adolescents with severe obesity - results after one year. Skodvin, VA., Lekhal, S., Kommedal, KG., et al.[2021]

Citations

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

Behavioral Weight Loss Intervention Preferences ... Behavioral interventions to treat adolescent obesity should focus messaging/content on healthy lifestyles, rather than weight loss, and be sex stratified.

2. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15278

Behavior‐change lifestyle interventions for the treatment of ... This scoping review discusses optimal behavior-change lifestyle interventions in the treatment of overweight and obesity in children and adolescents.

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

Obesity Treatment Among Adolescents: A Review of ... Behavioral strategies common among adolescent obesity interventions include diet and physical activity modification and behavioral counseling. Multicomponent, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525000920

The effectiveness of school-based obesity prevention ... The aim of this study is to synthesise the effects of child obesity prevention programs on diet, physical activity, tobacco smoking and alcohol intake.

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

Evidence Base Update on Behavioral Treatments for ... This review provides an update to a previous Evidence Base Update addressing behavioral treatments for overweight and obesity in children and adolescents.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4293700/

The COPE healthy lifestyles TEEN randomized controlled ... The primary aim of the study is to evaluate if teens in the COPE TEEN intervention have higher healthy lifestyle behaviors, less weight gain and less depressive ...

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

Interventions for Weight Management in Children and ... In the short term, weight management interventions led to lower BMI in children and adolescents, with no evidence of serious harm.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025000537

Effects of lifestyle interventions on mental health in children ... Lifestyle interventions modestly improve depressive symptoms and quality of life in children and adolescents with overweight or obesity.